WO2012106593A2 - Dispositifs, systèmes et procédés d'évaluation de lésion de nerf périphérique - Google Patents

Dispositifs, systèmes et procédés d'évaluation de lésion de nerf périphérique Download PDF

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Publication number
WO2012106593A2
WO2012106593A2 PCT/US2012/023761 US2012023761W WO2012106593A2 WO 2012106593 A2 WO2012106593 A2 WO 2012106593A2 US 2012023761 W US2012023761 W US 2012023761W WO 2012106593 A2 WO2012106593 A2 WO 2012106593A2
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Prior art keywords
subject
pressure
pain
probe
body part
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WO2012106593A3 (fr
Inventor
Robert Perry TUCKETT
David Hardie BRADSHAW
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University of Utah Research Foundation Inc
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University of Utah Research Foundation Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
    • A61B5/4041—Evaluating nerves condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4824—Touch or pain perception evaluation
    • A61B5/4827—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency

Definitions

  • This invention relates to devices, systems, and methods for assessing peripheral nerve damage in a subject by monitoring the subject's pain threshold.
  • Small-fiber, peripheral sensory neuropathy has a significant impact on health and economic outcomes in the United States. Some neuropathies are caused by chemical neurotoxicity (e.g., pharmaceutical interventions, alcoholism, environmental toxins) and work-related injuries (e.g., carpal tunnel and hand-arm vibration syndromes), while others are caused by oxidative stress related to metabolic syndrome, diabetes, and age-related diseases. Secondary consequences of peripheral neuropathy include silent heart attack; cutaneous ulceration and infection; hearing deficit; dizziness; or decreases in motor function, fine motor skill, and balance. In some cases, consequences can be life-threatening.
  • chemical neurotoxicity e.g., pharmaceutical interventions, alcoholism, environmental toxins
  • work-related injuries e.g., carpal tunnel and hand-arm vibration syndromes
  • secondary consequences of peripheral neuropathy include silent heart attack; cutaneous ulceration and infection; hearing deficit; dizziness; or decreases in motor function, fine motor skill, and balance. In some cases, consequences can be life-threatening.
  • Dying-back neuropathies which lead to an increased pain threshold, most commonly result from ingestion of therapeutic agents with neurotoxic side effects and from metabolic disorders (e.g., diabetes).
  • the most common complication of diabetes is neuropathy.
  • diabetes is the most common cause of neuropathy in the western world. From 1980 to 2008, diabetes in the United States has more than tripled. An estimated 24 million individuals (7.8%) of the general population of the United States currently have diabetes. In the over-65 subpopulation, the diabetes rate is much greater, ranging from 18- 25%.
  • #1267884vl older suffer from impaired fasting glucose and obesity, both of which are significant diabetes risk factors.
  • the Center for Disease Control estimates diabetes rates in the United States may approach 33% of the general population by 2050. About half of diabetic patients develop peripheral neuropathy, from which a majority (80-90%) exhibit painless symptoms (e.g., loss of pain-related sensation) that progress to complete sensory loss on the extremities. Inability to sense injury increases risk of trauma, infection and eventual amputation. These demographic changes have created an expanding market for products that diagnose and monitor neuropathic symptoms and complications.
  • a principal barrier to the diagnosis, monitoring and understanding of dying-back neuropathy is a limited ability to directly quantify its effects on neural function.
  • a critical barrier to increased utility of central nervous system (CNS) imaging is the lack of non-magnetic stimulators that quantitatively activate peripheral sensory pathways.
  • thermal devices can also cause burn trauma to a patient due to the patient's loss of sensation. With repeated applications, heat can also be sensitizing, leading to an inflammatory response. These problems are particularly concerning for diabetic patients, who typically have compromised skin repair mechanisms and may experience heat-induced skin damage before the patient senses the stimulus. In contrast, through application of mechanical pressure, elevations in the pain threshold of a patient can be measured without inflammatory response.
  • Hand-held pressure-sensing devices i.e., algometers range from spring gauges to electronic load cells used to locate areas of tenderness and "trigger points.”
  • the system has a pressure application device for applying pressure to a selected body part of the subject.
  • the pressure application device has a platform for supporting the selected body part, a probe for contacting and applying pressure to the selected body part, and means for moving the probe along a displacement axis such that the probe contacts and applies pressure to the selected body part.
  • the system has a computer equipped with a processor and a memory in communication with the processor.
  • the processor is in further communication with the means for moving the probe along the displacement axis.
  • the processor is configured to activate the pressure application device to apply pressure to the selected body part in a desired patter.
  • the processor is further configured to instruct the pressure application device to discontinue application of pressure to the selected body part when a pain threshold for the subject or a predetermined pressure level is achieved.
  • Figure 1 is a schematic diagram of an exemplary system for assessing peripheral nerve damage in a subject, as described herein.
  • Figure 2 is a perspective view of an exemplary pressure application device as described herein.
  • Figure 3 is a schematic diagram of exemplary means for moving the probe of a pressure application devices a described herein.
  • the exemplary means for moving the probe of the pressure application device includes a pressure regulator assembly and a solenoid valve.
  • Figure 4 is a schematic diagram depicting exemplary configurations of the solenoid valve depicted in Figure 3.
  • FIG. 5-9 describe various exemplary applications of the pressure application devices described herein.
  • Figures 10-12 display the results of an exemplary experimental use of an exemplary pressure application device as described herein.
  • Ranges can be expressed herein as from “about” one particular value, and/or to "about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • the invention relates to a system for assessing peripheral nerve damage in a subject.
  • the system 10 can comprise a pressure application device 12 for applying pressure to a selected body part of the subject.
  • the selected body part of the subject can be one of a nail bed of a selected finger, such as, for example and without limitation, a thumb, and a nail bed of a selected toe, such as, for example and without limitation, a big toe.
  • the system 10 can comprise a computer 40 and/or microprocessor 42 in communication with the pressure application device 12.
  • the pressure application device 12 can comprise a platform 14 for supporting at least a portion of the selected body part of the subject.
  • the pressure application device 12 can comprise a probe 16 having a tip 18.
  • the tip 18 of the probe 16 can be configured to contact and apply pressure to at least a portion of the selected body part of the subject.
  • the shape and dimensions of the tip 18 of the probe 16 can be selectively varied depending on the selected body part of the subject to which the probe applies pressure.
  • the pressure application device 12 can comprise means for moving the probe 16 along at least one displacement axis 20 such that the probe contacts and applies pressure to the selected body part of the subject.
  • the means for moving the probe along the at least one displacement axis can be configured to move the probe such that the probe applies a predetermined pressure to the selected body part of the subject.
  • the means for moving the probe along the at least one displacement axis can comprise, for example and without limitation, any conventional electrical, motorized, or pneumatic means for axial advancement of an object, provided the electrical, motorized, or pneumatic means permits sufficient control of the pressure applied to the selected body part of the subject.
  • the predetermined pressure can range from about 0 psi to about 50 psi.
  • the predetermined pressure can be any pressure that is tolerated by a normal subject without inducing significant tissue injury to the selected body part.
  • the pressure application device 12 can further comprise a hand grip 17 shaped to conform to a hand of the subject.
  • a top portion of the hand grip 17 can define the platform 14 of the pressure application device 12 and, consequently, support the selected finger of the subject.
  • the platform can be spaced from the probe along the at least one displacement axis 20.
  • the computer 40 can have a processor 42 and a memory 44 in communication with the processor.
  • the processor 42 can be in further communication with the means for moving the probe along the at least one displacement axis.
  • the processor 42 can be configured to perform the step of activating the pressure application device 12 to apply pressure to the selected body part in a desired pattern.
  • the processor 42 can be configured to perform the step of instructing the pressure application device 12 to discontinue application of pressure to the selected body part when a pain threshold for the subject is achieved.
  • the system 10 can further comprise means for the subject to indicate that the pain threshold has been achieved.
  • the processor 42 can be configured to perform the step of instructing the pressure application device 12 to discontinue application of pressure to the selected body part when a predetermined pressure level is achieved.
  • the predetermined pressure level can correspond to the maximal pressure level that can be achieved without causing tissue damage to the selected body part.
  • the desired pattern of applying pressure to the selected body part comprises application of a series of gradually increasing pressure stimulations.
  • each pressure stimulation can have a desired duration.
  • the increases in pressure between consecutive pressure stimulation can be substantially non-linear.
  • the desired duration of each pressure stimulation can vary among the series of pressure stimulations.
  • the duration of the release periods associated with the series of pressure stimulations can be variable.
  • the desired series of pressure stimulations can be applied to the patient in a random sequence, i.e., not limited to a series of linear or non-linear step increases, but rather in a random application of varied pressure stimulations that can increase or decrease sequentially as the desired pattern of applying pressure to the selected body part is run.
  • the system 10 can further comprise a heart rate monitor 30 in electrical communication with the processor 42 of the computer 40.
  • the heart rate monitor 30 can be configured to produce a heart rate signal indicative of the heart rate of the subject.
  • the system 10 can be configured to cease application of pressure to the selected body part of the subject when a predetermined heart rate of the subject is achieved. In an exemplary aspect, it is
  • heart rate monitor 30 can be incorporated into the hand grip 17 of the pressure application device 12.
  • the system 10 can further comprise a blood pressure monitor 32 in electrical communication with the processor 42 of the computer 40.
  • the blood pressure monitor 32 can be configured to produce a blood pressure signal indicative of the blood pressure of the subject. It is further contemplated that the system 10 can be configured to cease application of pressure to the selected body part of the subject when a predetermined blood pressure of the subject is achieved.
  • the system 10 can further comprise an electrocardiogram device 34.
  • the electrocardiogram device 34 can be positioned in electrical communication with the processor 42 of the computer 40.
  • the system 10 can further comprise means for measuring skin conductance of the subject, such as, for example and without limitation, a conventional biofeedback monitor.
  • the means for measuring skin conductance can be in communication with the processor 42 of the computer 40. It is further contemplated that the means for measuring skin conductance can be configured to produce a signal indicative of the skin conductance of the subject.
  • the system 10 can further comprise a magnetic resonance imaging (MRI) machine 36.
  • MRI magnetic resonance imaging
  • the MRI machine 36 can be in communication with the processor 42 of the computer 40.
  • the pressure application device 12 can comprise non-magnetic materials that enable the pressure application device to be used effectively with the MRI machine 36.
  • the pressure application device 12 can further comprise at least one pressure sensor.
  • a pressure sensor 19 can be positioned within the tip 18 of the probe 16 and in electrical communication with the processor 42 of the computer.
  • a pressure sensor 15 can be positioned within the platform 14 and in electrical communication with the processor 42 of the computer.
  • the at least one pressure sensor can be configured to produce a pressure signal indicative of the pressure applied to the selected body part of the subject.
  • the system 10 can further comprise at least one shield that is configured to be mounted between the patient and the pressure application device. It is contemplated that the at least one shield can be sized and shaped to block the visual sight lines of a patient being tested so that the sequence of pressure applications being applied by the pressure application device to the patient can be accomplished without the patient being able to visually discern the testing protocol.
  • the pressure application device 12 can further comprise a displacement monitor 22 for measuring axial movement of the probe 16 along the at least one displacement axis 20.
  • the displacement monitor 22 can be in communication with the processor 42 of the computer 40. It is further contemplated that the displacement monitor 22 can be configured to produce a displacement signal indicative of the distance by which the probe 16 is moved along the at least one displacement axis 20.
  • the means for moving the probe along the at least one displacement axis can comprise a chamber 24 containing a piston 26 operably coupled to the probe 16 of the pressure application device 12.
  • the piston 26 can be axially moveable within the chamber 24 along the at least one displacement axis 20.
  • the means for moving the probe along the at least one displacement axis can further comprise at least one pressure regulator 28 in communication with the chamber 24.
  • the at least one pressure regulator 28 can be configured to generate sufficient pressure within the chamber 24 to advance the piston 26 along the at least one displacement axis 20 such that the probe 16 applies pressure to the selected body part of the subject in the desired pattern.
  • the at least one pressure regulator 28 can comprise an air inlet for receiving pressurized air.
  • the at least one pressure regulator 28 can comprise a pump for pumping pressurized air into the air inlet.
  • each pressure regulator 28 of the at least one pressure regulator can comprise a conventional pressure valve, such as, for example and without limitation, a solenoid valve 29.
  • each pressure regulator 28 can comprise a 2-port, 2-position (2/2) solenoid valve.
  • the solenoid valve of each pressure regulator 28 can be in selective electrical communication with a power switch that is moveable about and between an on position and an off position.
  • each pressure regulator 28 can be in communication with the processor 42 of the computer 40.
  • the at least one pressure regulator 28 can comprise three pressure regulators, and each pressure regulator can be configured to regulate pressure at predetermined pressure output levels.
  • the at least one pressure regulator can comprise a high-pressure regulator (labeled H), a medium-pressure regulator (labeled M), and a low-pressure regulator (labeled L).
  • the chamber 24 can have a first port 25a and a second port 25b for receiving pressurized gas from the at least one pressure regulator 28.
  • the piston 26 can be positioned between the first port 25a and the second port 25b along the at least one displacement axis 20.
  • the means for moving the probe along the at least one displacement axis can further comprise a solenoid valve 29 positioned between and in communication with the at least one pressure regulator 28 and the first port 25a and second port 25b of the chamber 24.
  • the solenoid valve 29 can be in electrical communication with the processor 42 of the computer 40.
  • the solenoid valve 29 can be moveable between a first position and a second position.
  • the solenoid valve 29 can be configured to apply pressure to the piston 26 through the first port 25a such that the probe 26 is moved along the at least one displacement axis 20 toward the selected body part of the subject.
  • the solenoid valve 29 can be configured to apply pressure to the piston 26 through the second port 25b such that the probe 16 is moved along the at least one displacement axis 20away from the selected body part of the subject.
  • the solenoid valve 29 can be a 4-port, 2-position solenoid valve or a 5-port, 2-position (5/2) solenoid valve.
  • the system 10 can comprise a frame 50 configured to stabilize the pressure application device 12.
  • the frame 50 can define an open space within which the probe 16 of pressure application device 12 can be operatively positioned for selective movement along the at least one displacement axis 20.
  • the frame can comprise means for adjusting the position of the pressure application device within a plane substantially perpendicular to the displacement axis 20 along which the probe moves (as shown in Figure 2).
  • the means for adjusting the position of the pressure application device 12 within the described plane can comprise two pairs of spaced knobs 52 and 54 that are operatively coupled to the pressure application device.
  • Each pair of knobs can be configured to effect movement of the pressure application device 12 along a particular axis; the first pair of knobs 52 can be configured to effect movement of the device along a first axis, and the second pair of knobs 54 can be configured to effect movement of the device along a second axis.
  • rotation of a first knob can correspond to movement of the device 12 in a first direction along the axis, while rotation of a second knob can correspond to movement of the device in an opposite direction along the axis.
  • the frame can comprise a threaded backer block that is coupled to the device 12 and at least one pair of knobs, thereby providing operative coupling between the at least one pair of knobs and the device.
  • the knobs of the first and second pairs of knobs 52 and 54 can comprise knurled plastic knobs.
  • the disclosed system can be incorporated into a method for assessing peripheral nerve damage in the subject.
  • the method can comprise providing a pressure application device comprising a platform and a probe, as described herein.
  • the method can comprise positioning the selected body part of the subject on the platform of the pressure application device.
  • the method for assessing peripheral nerve damage in the subject can comprise selectively moving the probe along the at least one displacement axis such that the tip of the probe contacts and applies pressure to the selected body part of the subject.
  • the step of selectively moving the probe along the displacement axis can comprise moving the probe along the at least one displacement axis such that a series of gradually increasing pressure stimulations are applied to the selected body part of the subject. It is contemplated that each pressure stimulation can have a desired duration. It is further contemplated that the increases in pressure between consecutive pressure stimulations can be substantially non-linear. It is still further contemplated that the desired duration of each pressure stimulation can vary among the series of pressure stimulations.
  • the desired series of pressure stimulations can be applied to the patient in a random sequence, i.e., not limited to a series of linear or non-linear step increases, but rather in a random application of varied pressure stimulations that can increase or decrease sequentially as the desired pattern of applying pressure to the selected body part is run.
  • the method for assessing peripheral nerve damage in the subject can comprise measuring the pressure applied to the selected body part of the subject. In still another aspect, the method can comprise measuring the axial movement of the probe along the at least one displacement axis.
  • the method for assessing peripheral nerve damage in the subject can comprise monitoring whether a pain threshold for the subject is achieved.
  • the step of monitoring whether the pain threshold is achieved can comprise receiving feedback from the subject in response to the application of pressure to the selected body part of the subject. It is further contemplated that the step of monitoring whether the pain threshold is achieved can comprise determining whether a predetermined threshold pressure is applied to the selected body part of the subject. It is still further contemplated that the step of monitoring whether the pain threshold is achieved can comprise determining whether the probe has been moved along the displacement axis by a
  • the method for assessing peripheral nerve damage in the subject can comprise discontinuing application of pressure to the selected body part of the subject when the pain threshold of the subject is achieved.
  • the processor can be configured to perform the step of instructing the pressure application device to discontinue application of pressure to the selected body part when a predetermined pressure level is achieved.
  • the predetermined pressure level can correspond to the maximal pressure level that can be achieved without causing tissue damage to the selected body part.
  • the method for assessing peripheral nerve damage in the subject can further comprise the step of measuring the heart rate of the subject.
  • the step of monitoring whether the pain threshold has been achieved can comprise determining whether a predetermined threshold heart rate of the subject has been achieved.
  • the method for assessing peripheral nerve damage in the subject can further comprise the step of measuring the blood pressure of the subject.
  • the step of monitoring whether the pain threshold has been achieved can comprise determining whether a predetermined threshold blood pressure of the subject has been achieved. It is further contemplated that
  • predetermined threshold blood pressure can be one of a predetermined mean, diastolic, or systolic blood pressure.
  • the step of monitoring whether the pain threshold has been achieved can comprise receiving a report of pain from the subject.
  • the report of pain can be a verbal report of pain from the subject.
  • the subject can provide a description of the experienced pain, such as, for example and without limitation, "sharp,” “dull,” or “aching.”
  • the subject can provide a numeral indicative of the magnitude of experienced pain, such as a number between 1 and 10, with 10 being indicative of the most intense pain.
  • the report of pain can be non-verbal.
  • the non-verbal report of pain can be at least one of: a written description of pain; holding up a sign indicative of the magnitude of experienced pain; pointing to an indicator of the magnitude of experienced pain; pressing a button in communication with the processor of the system, the button being indicative of the magnitude of experienced pain; and entering an indicator of the magnitude of experienced pain using a keypad in communication with the processor of the system.
  • the step of monitoring whether the pain threshold has been achieved can comprise monitoring whether a predetermined threshold respiration rate of the subject has been achieved. In still a further aspect, it is contemplated that the step of monitoring whether the pain threshold has been achieved can comprise monitoring whether a pupil of the subject has expanded to a predetermined diameter. In yet another aspect, it is contemplated that the step of monitoring whether the pain threshold has been achieved can comprise whether the skin of the subject has reached a predetermined threshold skin resistance. In still another aspect, it is contemplated that the step of monitoring whether the pain threshold has been achieved can comprise monitoring the activation of the subject's CNS pain pathway through analysis of an electroencephalogram (EEG) or other conventional monitoring technique.
  • EEG electroencephalogram
  • the step of monitoring whether the pain threshold has been achieved can comprise correlating changes in various monitored parameters, including, for example and without limitation, the parameters described herein. It is further contemplated that the step of monitoring whether the pain threshold has been achieved can comprise determining whether the correlated monitored parameters form a pattern that is indicative of achievement of the pain threshold.
  • the method for assessing peripheral nerve damage in the subject can further comprise comparing the measured pain threshold of the subject to the pain threshold of healthy subjects. It is further contemplated that the pain threshold of the subject can be age-corrected as appropriate to improve diagnostic accuracy. It is still further contemplated that the method can comprise tracking the progression of the subject's pain threshold over time.
  • the disclosed system can also be incorporated into a method for monitoring changes of the pain threshold in the peripheral nerves of the subject.
  • the method can comprise providing a pressure application device comprising a platform and a probe, as described herein.
  • the method can comprise positioning the selected body part of the subject on the platform of the pressure application device.
  • the method for monitoring changes of the pain threshold of the subject can comprise selectively moving the probe along the displacement axis such that the tip of the probe contacts and applies pressure to the selected body part of the subject.
  • the method can comprise measuring the pressure applied to the selected body part of the subject.
  • the method can comprise measuring the axial movement of the probe along the displacement axis.
  • the method for monitoring changes of the pain threshold in the peripheral nerves of the subject can comprise measuring the pain magnitude experienced by the subject during application of pressure to the selected body part of the subject. In still another aspect, the method can comprise comparing the measured pain magnitude corresponding to a selected applied pressure to the pain magnitude experienced by normal patients upon application of the selected applied pressure. In yet another aspect, the method can comprise comparing the measured pain magnitude corresponding to a selected applied pressure to one or more previously recorded pain magnitudes for the subject corresponding to the selected applied pressure. In still a further aspect, the method can comprise determining whether the pain threshold for the subject has changed. In additional aspects, it is contemplated that the measured pain magnitude can be age-corrected as appropriate to improve diagnostic accuracy.
  • the step of measuring the pain magnitude experienced by the subject can comprise receiving feedback from the subject indicative of the pain magnitude.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring the strength of the grip of the subject during application of pressure to the selected body part of the subject.
  • the magnitude of the strength of the grip can correspond to the pain magnitude experienced by the subject.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring the finger pinch strength of the subject during application of pressure to the selected body part of the subject.
  • the magnitude of the finger pinch strength can correspond to the pain magnitude experienced by the subject.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring a movement by the subject.
  • the amount of movement by the subject can correspond to the pain magnitude experienced by the subject.
  • the measured movement by the subject can be movement of a handle.
  • the measured movement of the subject can be twisting of a pointer.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring the intensity of a beam of light controlled by the subject. In this aspect, it is contemplated that the intensity of the beam of light can correspond to the pain magnitude experienced by the subject. In a further aspect, the step of measuring the pain magnitude experienced by the subject can comprise measuring the finger span of the subject. In this aspect, it is contemplated that the finger span can be indicative of the separation between the thumb and the index finger of a hand of the subject. It is further contemplated that the measured finger span of the subject can correspond to the pain magnitude experienced by the subject. It is still further contemplated that the finger span of the subject can be measured using a conventional potentiometer coupled to the fingers of the subject. In still another aspect, the step of measuring the pain magnitude experienced by the subject can comprise measuring the heart rate of the subject. In this aspect, it is contemplated that the heart rate of the subject can be indicative of the pain magnitude experienced by the subject.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring the blood pressure of the subject. In this aspect, it is contemplated that the measured blood pressure of the subject can be indicative of the pain magnitude experienced by the subject. In still another aspect, the step of measuring the pain magnitude experienced by the subject can comprise measuring the body temperature of the subject. In this aspect, it is contemplated that the body temperature of the subject can be indicative of the pain magnitude experienced by the subject. In still a further aspect, the step of measuring the pain magnitude experienced by the subject can comprise measuring the skin conductance of the subject. In this aspect, it is contemplated that the skin conductance of the subject can be indicative of the pain magnitude experienced by the subject.
  • the step of measuring the pain magnitude experienced by the subject can comprise measuring one of the respiration rate and the pupil diameter of the subject, which can be indicative of the pain magnitude experienced by the subject.
  • the step of measuring the pain magnitude experienced by the subject can comprise monitoring the activation of the CNS pain pathway of the subject through analysis of an EEG or other conventional monitoring technique.
  • the disclosed devices and systems can be employed in methods for monitoring a subject's response to subthreshold (below the pain threshold of a subject) and/or suprathreshold (above the pain threshold of a subject) pressures. It is further contemplated that these methods can correspond to the methods previously described herein except that these methods are not used to monitor changes in pain threshold, but are instead used to monitor a subject's response to application of subthreshold and/or suprathreshold pressures. In one exemplary aspect, it is contemplated that the methods for monitoring a subject's response to subthreshold and/or suprathreshold pressures can be used to measure and track a subject's tactile sensation of touch.
  • the disclosed methods when used to apply suprathreshold pressures to a subject, it is contemplated that the subject's responses to particular qualities of pain can be measured and monitored.
  • the qualities of pain can include, for example and without limitation, pricking, stinging, burning, sharpness, dullness, and the like.
  • neuropathy and other chronic pain conditions can alter the ability of a subject to experience one or more qualities of pain.
  • the disclosed methods can be used in a "double-blind" manner such that neither the subject nor the doctor/operator is aware of when the application of pressure to the subject will occur.
  • the subject can take an action as described herein to cease application of pressure.
  • a sequential application of pressure can occur at a time that is unknown to both the subject and the doctor/operator.
  • the nail bed of a finger or a toe of the subject can evenly distribute the applied pressure. It is further contemplated that the nail bed of a finger or a toe of the subject will not adapt to repeated stimulations and will not be damaged by applied pressures that are above a pain threshold of the subject.
  • the selected body part of the subject can be any body part of the subject that permits assessment of changes in the pain threshold within the subject.
  • the selected body part can be selected depending on whether the disclosed devices, systems, and methods are being used to assess decreases in pain threshold, such as those related to increased sensitivity to pain, including hyperalgesia and allodynia, or increases in pain threshold, such as in hypoalgesia, including hypoalgesia produced by neuronal death associated with diabetes.
  • the pain threshold of the subject should be measured at sensitive "trigger points.”
  • the "trigger points" can be located along the neck of the subject.
  • the disclosed devices, systems, and methods are used to assess decreased sensitivity to pain
  • pressure can be applied to areas of peripheral nerve innervation on the body of the subject as described herein to track and quantify nerve regeneration, such as nerve regeneration that occurs following nerve or surgical repair of tendons, including nerve regeneration associated with physical rehabilitation.
  • nerve regeneration such as nerve regeneration that occurs following nerve or surgical repair of tendons, including nerve regeneration associated with physical rehabilitation.
  • the selected body part of the subject can be selected depending on the distribution of nerve innervation.
  • the selected body part can be the glabrous surfaces of the hands and feet of the subject.
  • the glabrous surfaces can comprise small areas of denervation that can be at increased risk of injury.
  • the feet of a diabetic subject can have altered pressure profiles that can lead to nerve and tissue damage, as well as problems in detecting tissue injury and in selecting shoes to wear.
  • identification of areas on the selected body part with greatest loss of pain sensitivity can be used to design appropriate orthotics for the subject.
  • nerve compression syndromes radiculopathies
  • the nerves of a subject can compress where they enter the spine, thereby leading to either increased or decreased pain thresholds. It is contemplated that the disclosed devices, systems, and methods can be used to measure pain threshold over the spine of the subject to localize the area of nerve compression in the subject.
  • the disclosed devices and systems can be coupled with brain imaging technologies to identify specific areas of the brain or spinal cord of the subject that are injured or have been modified by neuroplastic mechanisms associated with conditions such as chronic pain, depression, or stressful events, such as, for example and without limitation, events related to post-traumatic stress disorder.
  • pressure can be applied to a plurality of body parts of the subject to assess the subject's pain threshold at various body surfaces.
  • stimulation at different dermatome levels can be used to determine the location of a spinal cord tumor that is blocking transmission of pain-related information.
  • the disclosed devices, systems, and methods can be used to detect nociceptor nerve damage within a foot of a subject.
  • nociceptor damage within the foot of a subject can be indicative of a generalized foot injury that can lead to compromised circulation, foot amputation, infection, and, potentially, death.
  • the disclosed devices, systems, and methods can be used to assess damage to pain-signaling fibers within the heart of a subject.
  • damage to pain-signaling fibers within the heart can increase the risk of the subject suffering a silent heart attack and, subsequently, heart failure.
  • the disclosed devices, systems, and methods cannot directly measure damage to these pain-signaling fibers, there can be a strong correlation between cutaneous nociceptor damage and nociceptor damage in the heart.
  • the disclosed devices, systems, and methods can be used in a screening program for detecting heart attack risk factors.
  • peripheral diabetic neuropathy can be present in a subject before the subject fully develops diabetes. It is further contemplated that such subjects can suffer early damage to sensory nerves in the heart, thereby contributing to the heart attack risk of the subjects.
  • the disclosed devices, systems, and methods can be used in the drug development process. In this aspect, it is contemplated that the disclosed devices, systems, and methods can be used to demonstrate efficacy of medications that are used to treat diabetic neuropathy in human populations.
  • the disclosed devices, systems, and methods can be used to identify drugs that are most efficacious at treating the diabetic neuropathies suffered by individual patients. It is further contemplated that the disclosed devices, systems, and methods can be used to determine appropriate dosing profiles for individual patients who are taking medications to treat diabetic neuropathy.
  • the disclosed devices, systems, and methods can be used in drug selection by helping patients to avoid ingestion of drugs that are likely to increase their risk of peripheral sensory neuropathy.
  • the disclosed devices, systems, and methods can be used in drug selection and rotation for patients who are prescribed anti-arthritic drugs, which typically are associated with a high risk of peripheral sensory neuropathy.
  • the disclosed devices, systems, and methods can be used to monitor peripheral nerve damage that is caused by drug interactions.
  • the disclosed devices, systems, and methods can be used to monitor whether combined therapy with platinum-based compounds, such as cisplatin, taxanes, such as Taxol, and other anti-cancer drugs is leading to peripheral sensory neuropathy. It is further contemplated that, if physicians can determine the extent of peripheral nerve damage in a patient, then the physicians can be more aggressive when prescribing medications.
  • fJVIRI procedures can be performed on a normal subject population on three different days, with a one-week interval in between each of the three procedures (see Figure 5B).
  • Each subject can be placed in an fMRI device, with the subject's vital signs (heart rate, blood pressure, respiratory rate) being monitored until they reach a stable, resting level (requiring about 5 min). Recording of endpoint
  • a baseline scan can be collected to document the central nervous system (CNS) "resting state.”
  • CNS central nervous system
  • the stimulation can be applied using the pressure application devices and systems described herein.
  • pressure can gradually increase until the pain threshold is reached.
  • the pressure increase (0.1 psi/sec, as shown in Figure 5 A) can be slow enough for subjects to react before the stimulus pressure increases significantly beyond the pain threshold.
  • the subject can always have the option of immediately stopping the stimulation by removing their thumb from the apparatus (see Figure 2), at which point pressure on the nail bed immediately decreases to zero.
  • CNS speech pathway activation is necessary to verbally indicate pain threshold.
  • pressing an "event button” activates CNS pathways for hand/finger movement (e.g., somatosensory and motor areas).
  • the order of trials can be randomized with at least a 4-min interval between trials.
  • the first trial can require the subject to push an event button when she/he detects pain
  • the second trial can require the subject to verbally indicate her/his pain threshold to the supervising user
  • the third trial can be based upon an automatic response (in accordance with real-time monitoring of the subject's heart rate, blood pressure, and respiratory rate).
  • an upward trend greater than 10%
  • the supervising user halts the increase in probe pressure being applied to the subject. Since approximately 2.5 seconds are required to perform a whole head scan, the stimulus probe pressure can be maintained at the threshold level for about 5.0 seconds to ensure that peak brain activation is captured, after which the probe pressure can be returned to zero.
  • the lag between neural circuit activation and change in blood flow is approximately 20 sec; therefore, the brain imaging process can continue for at least 25 sec following pain detection in order to capture the entire dynamic change in neural activation.
  • VAS Visual Analog Scale
  • An fMRI operator can oversee the brain-imaging and data analysis, and a
  • the study coordinator can examine the subject's nail bed and surrounding tissue for signs of injury before each procedure.
  • the coordinator can examine the finger immediately following each stimulation (Visits 2, 3, 4) for signs of injury and ask the subject to report any tenderness or other sign of injury. If injury is observed before stimulation, the time and date of stimulation is delayed until the area to be stimulated has recovered. If recovery is delayed more than 2 weeks, the subject is removed from the study, but is followed up until the injury resolves. All injuries can be tracked daily by phone interview or direct observation until resolution. If injury is documented, the study physician can determine whether to lower the Maximum Pressure Limit for all remaining trials.
  • a great disadvantage of using thermal devices to measure pain is that they are sensitizing and therefore obtaining repeated measures during brain imaging is not feasible. It is contemplated that the above-described procedures can be used to test whether physiological indices of pain response (heart rate, blood pressure and respiration rate) differ significantly from baseline when pain threshold is exceeded using mixed effects linear regression models. It is further contemplated that the above-described procedures can be used to determine which physiological indicator of pain is the earliest indicator of pain threshold. It is still further contemplated that the above-described procedures can be used to determine whether the three different threshold triggering techniques correlate with activation of pain-related pathways in the fJVIRI imaging.
  • Each triggering technique at the point of its time mark is an interval scale, or continuous variable.
  • the pain-related pathway is likewise an interval scale that is recorded simultaneously with the pressure measurement.
  • These pairs of measurements are collected three times during each of three visits.
  • a mixed effects linear regression model can be fitted to these data to account for the repeated measurements.
  • the neuroanatomy consultant who is blinded as to category, can rank the scans according to which have the cleanest imaging. The category rankings will then be tested for significance using a Chi Square test.
  • ICC intraclass correlation coefficient
  • Bland-Altman analysis can be performed to assess if differences between repeated measurements of pain are within clinically acceptable agreement.
  • the devices and systems described herein can be used to study subjects that have been diagnosed with diabetic neuropathy.
  • Subjects can participate in a sensory nerve conduction latency experiment in which stimulating electrodes are placed over the median nerve proximal to the wrist and recording electrodes in the sensory nerves of the middle finger.
  • Standard electrophysiology equipment (Viking Quest, Nicolet, Inc.) can record the latency of the sensory compound action potential at the level of the middle finger.
  • Conduction velocity can be calculated by distance between stimulating and recording electrodes by the conduction latency from stimulus artifact to peak of compound wave.
  • Patients with a history of carpal tunnel or other non-diabetic peripheral neuropathy can be excluded from the study.
  • the Maximum Pressure Limit for these applications can initially be set to 12 psi on the first stimulation visit (Visit 2, see Figure 6) as discussed below. Pressure can be increased at about 0.5 psi/sec, as shown in Figure 6A, which is slow enough for subjects to react before there is a significant increase in stimulus intensity beyond threshold.
  • the subject can stop the stimulus by instructing the operator to release the stimulus or by removing their thumb from the apparatus (see Figure 2), at which point pressure on the nail bed immediately decreases to zero.
  • Stimulus pressure can increase until it reaches either threshold or the Maximum Pressure Limit (see Figure 6A). If threshold is below the Maximum Pressure Limit, the stimulus cycle can be repeated twice more (see Figure 6B) to measure
  • the study coordinator can examine the subject's nail bed and surrounding tissue for signs of injury before each experiment and ask the subject to report any tenderness or other sign of injury. If any abnormality is observed, or the subject reports injury or sensitization, the subject can be examined by a health care professional (physician's assistant) under the supervision of the study physician. If the health care professional feels that there is injury, the subject is examined by a study physician who decides whether the Maximum Pressure Limit defined in Figure 7 should be reduced. If injury is observed before stimulation, stimulation day is delayed until the area to be stimulated has recovered. If recovery is delayed more than 2 weeks, the subject is removed from the study, but is followed up until the injury resolves. All injuries are tracked daily by phone interview or direct observation until resolution.
  • a mixed effects linear regression model can be fitted to the various outcome variables. It is contemplated that the model can correctly account for the lack of independence of the repeated measurements nested within study subject data and also allow for an unequal number of completed follow- up visits (as well as unequal spacing of the visits), as patients inevitably return to the clinic at varying time intervals. Age and gender can be included as covariates in this model. It is contemplated that the above-described procedures can be used to test whether the threshold in the diabetic sample is significantly greater than the control sample using standard parametric means tests.
  • the above-described procedures can be used to test whether physiological indices of pain response (heart rate, blood pressure and respiration rate) differed significantly from baseline when pain threshold was exceeded using mixed effects linear regression models. It is still further contemplated that the above-described procedures can be used to determine which physiological indicator of pain is the earliest indicator of pain threshold using mixed effects linear regression models. It is still further contemplated that the above-described procedures can be used to determine whether deficits in clinical median nerve conduction velocity measures were correlated with pain threshold in the patient sample. The median nerve conduction velocity is a single interval scaled measurement taken at the baseline visit. It can be correlated with the pressure measurement at the point of pushing the button to indicate pain threshold, an interval scaled variable measured three times at each of the three visits.
  • a mixed effects linear regression model can be fitted to these data to account for the repeated measurements.
  • the median nerve conduction velocity can be a fixed value repeated nine times for each patient.
  • ICC intraclass correlation coefficient
  • Bland-Altman analysis can be performed to assess if differences between repeated measurements of pain are within clinically acceptable agreement.
  • the devices and systems described herein can be used to detect the pain threshold of a subject in an automated manner. Recording of endpoint physiological variables starts before stimulation and continues throughout the stimulation procedures. During Visit 2, pressure can be increased until pain threshold is reached. The pressure increase (0.1 psi/sec, see Figure 8A) can be slow enough for subjects to react before stimulus pressure increases significantly beyond threshold. The subject can stop the stimulus by instructing the operator to release the stimulus (or by removing their thumb from the apparatus, see Figure 2), at which point pressure on the nail bed immediately decreases to zero. To determine repeatability, three threshold measures can be obtained per visit (Figure 8B), with a 4-min interval between stimuli.
  • suprathreshold protocol can be performed. Pressure can be gradually increased (0.1 psi/sec) until the subject reports pain threshold and then continue to increase at the same rate until either the subject's maximum pain tolerance is reached (at which point the probe pressure is immediately reduced to zero (Figure 9 A)) or a preset Maximum Pressure Limit (see below) is exceeded (Figure 9A). If the pressure reaches the subject's level of maximum pain tolerance, the stimulus cycle can be repeated two more times to measure repeatability, with a 4-min interval between stimuli ( Figure 9B). Alternatively, if the pressure climbs above the Maximum Pressure Limit, stimulation can stop, and the stimulation site can be examined for signs of injury. If there is no evidence of injury, the investigators can consult with the study physician to determine whether the Maximum Pressure Limit can be increased.
  • the subject can quantify her/his pain rating using a O-to-10 Visual Analog Scale (VAS), where 0 equals no pain and 10 equals the maximum imaginable pain. Since "maximum tolerable pain" may be less than "maximum imaginable pain," the subject's pain rating at exit from the procedure can be less than 10.
  • VAS O-to-10 Visual Analog Scale
  • the study coordinator can examine the subject's nail bed and surrounding tissue for signs of injury before, and immediately following, each trial (Visits 2, 4, 6, 8) [as well as on the subsequent observation day (Visits 3, 5, 7, 9)] and ask the subject to report any tenderness or other sign of injury.
  • the subject can be examined by a health care professional (physician's assistant) under the supervision of the study physician. If the health care professional determines that there is injury, the subject can be examined by the study physician who decides whether the Maximum Pressure Limit (see above) should be reduced. If recovery is delayed more than 2 weeks, the subject can be removed from the study, but followed up with until the injury resolves. All injuries can be tracked daily by phone interview or direct observation until resolution.
  • a health care professional physician's assistant
  • a mixed effects linear regression model can be fitted to the various outcome variables. It is contemplated that this model correctly accounts for the lack of independence of the repeated measurements nested within study subject data and allows for an unequal number of completed follow-up visits, as well as unequal spacing of the visits as subjects inevitably return for repeated testing at varying time intervals. Age and gender are included as covariates in this model.
  • both the threshold and suprathreshold protocols can be used to: (a) test whether there is a significant increase in heart rate after stimulus exceeds pain threshold using a mixed effects linear regression model; (b) prepare a histogram of percent increase in heart rate above baseline versus percent increase in stimulus pressure above threshold to investigate autonomic response sensitivity; (c) analyze all endpoints (heart rate, blood pressure, pupil diameter, respiration rate, and skin resistance) to determine which has the greatest percentage change from baseline after pain threshold is exceeded; (d) determine whether the threshold measure obtained during threshold-only measurement (Visit 2) differs significantly from threshold measured using the suprathreshold stimulation (Visit 4); (e) measure reproducibility in the same-day, repeated measures of pain threshold using an intraclass correlation coefficient (ICC), reported with a 95% confidence interval; (f) measure reproducibility in the visit-to-visit, repeated measures of pain threshold using an intraclass correlation coefficient (ICC), reported with a 95% confidence interval (CI); (g) measure reproducibility in the same-day, repeated
  • a Bland-Altman analysis can be performed to assess if differences between repeated measurements of pain are within clinically acceptable agreement. These pairs of measurements can be collected three times at each of three visits. To test for correlation, then, a mixed effects linear regression model can be fitted to these data to account for the repeated measurements.
  • FM patients had physician diagnosed FM, confirmed by standard tender point (TP) examination and self-reported body pain areas according to the American College of Rheumatology classification criteria. Patients were able to maintain normal levels of daily activities including regular exercise but did not practice yoga or meditation. FM patients were recruited from community pain clinics.
  • TP tender point
  • Yoga practitioners were free of chronic pain and practiced yoga regularly for three or more years prior to enrollment. Participants practiced yoga three or more days a week for at least one hour a day and included vigorous physical, breathing and meditation exercises in their regular practice. Yoga practitioners who practiced kundalini yoga were recruited because this style uses standardized techniques and includes all the required elements as a regular part of daily practice. Practitioners of kundalini yoga often adopt lifestyle changes as well. YPs were recruited from contacts with local kundalini yoga instructors. [0093] Healthy volunteers had normal health without chronic pain complaints and normal activity levels that may include regular exercise but not yoga or meditation.
  • HVs were recruited by advertisements in the community.
  • Pain ratings were provided using an 1 1 -point numerical rating scale (NRS) with 0 indicating no pain and ten indicating the maximum tolerated pain.
  • NRS numerical rating scale
  • FIQ Fibromyalgia Impact Questionnaire
  • the 40 item State-Trait Anxiety Inventory was used to assess current (STAI- State) and enduring anxiety as a characteristic of the subject (STAI-Trait).
  • SCR skin conductance response
  • Pain threshold and three pressure levels were established for testing. Pressure was gradually increased until participants indicated they began to feel pain. The increase in pressure was continued until participants' reported pain reached 6 on the NRS. This process was repeated twice, and the pain threshold was set as the average of the three pressure levels. Three stimulus levels were then established: Very Low pressure (no pain) set at 20% below the individual's pain threshold, Low pressure (low pain) set at pain threshold, and High pressure (moderate pain) set at the average level corresponding to the individual's pain rating of six. This procedure was performed independently for each participant in order to determine the pressure levels required to produce moderate and low pain for that individual. After setting the pressure levels, the settings were tested to verify that they produced pain ratings corresponding to the desired levels.
  • the Even Odds condition had maximal uncertainty
  • the High Odds condition had maximal certainty for high pressure (painful)
  • the Low Odds condition had maximal certainty for low pressure (nonpainful) stimuli, respectively.
  • participants were informed of the likelihood of receiving high pressure during the block. Although in actuality participants received 1, 4, and 6 high pressure stimuli in each condition, respectively, in order to maintain the expectation of a possible high pressure stimulation to the end of the sequence, participants were told they may receive 1 additional high pressure stimulation.
  • each subject underwent uncertainty training prior to testing. This comprised picking colored marbles from a bag, with marble colors corresponding to the number of high and low pressure stimuli in each condition. Subjects practiced each condition until they correctly identified the corresponding condition, typically requiring one repetition for each condition.
  • Condition order was randomized across subjects. To allow participants to adapt to the experimental conditions and provide a response baseline, a control block of non- noxious stimuli (8 stimulations at sub-pain threshold pressure) was given before and after the three experimental conditions. Thus, participants received a total of 5 stimulus blocks, totaling 40 stimulations: 16 control and 24 experimental ( Figure 10).
  • FM patients After providing informed consent, FM patients underwent a tender points (TP) examination.
  • a trained project coordinator digitally palpated 18 American College of Rheumatology (ACR)-determined TPs and 3 control points in a predetermined order at 4kg force, at the rate of lkg/sec.
  • ACR American College of Rheumatology
  • patients rated the pain from 0 (no pain) to 10 (worst pain). All patients met the ACR criterion of having at least 1 1 positive TPs.
  • the wide-spread pain assessment was done using the Manual Tender Point Survey instrument.
  • Phase 1 Prior to testing, participants completed the self-report inventories, received procedure instructions and had sensors for psychophysiological measurement attached.
  • the test procedure comprised two phases. During Phase 1, participants' pain thresholds were established, and uncertainty training was conducted. Phase 2 comprised presentation of stimulus blocks. Stimulus trials comprised a 20 second rest period (pressure off) and a 20 second application of continuous and constant pressure (pressure on). Participants rated their pain after pressure release on each trial. At the end of each block, participants provided a pain expectation rating.
  • Phase 1 comprised an evaluation of pain threshold differences between subject groups.
  • a general linear model was used with pressure at pain threshold as the dependent measure and group as the fixed effect.
  • a mixed effects linear models was employed to analyze Phase 2 data, with stimulus level and pain certainty/uncertainty as manipulated within-subjects fixed effects and group association as a non-manipulated fixed effect.
  • the CSQ scale, STAI-Trait and STAI-State were treated as primary covariates in the analysis accounting for individual variation in affective influences.
  • Contributions of descriptive measures including BMI and age, and FMS symptom measures were evaluated as secondary covariates in the analysis.
  • Subjects' corresponding SCR, pain report, and expectancy measures were predicted by applying the following analytical model expressing a measure of subject i and combined fixed effects conditions j on dependent variable F as:
  • jj represents the expected cell mean j conditional on the covariates, represents individual differences (random effects) across subjects
  • ⁇ and ⁇ 2 are the cell-specific regression coefficients for the covariates.
  • This model permitted the usual analysis of variance hypothesis tests, including between groups comparisons on each measure and intervention comparisons, as well as evaluation of within subject repeated measures. Models were evaluated with all fixed effects factors and interactions included, and with the error structure providing the best parsimonious fit as determined by the Bayesian Information Criterion (BIC). The joint effects of the covariates were evaluated by likelihood ratio test among models with no covariates, linear covariates, and covariate-by-factor interactions. Contrasts among the model parameters were constructed to test custom a priori hypotheses regarding the differential effects of certain and uncertain pain expectation within and between groups at each stimulus level and across stimulus levels. All contrasts were evaluated at the means of significant covariates.
  • FM fibromyalgia
  • FfV healthy volunteers
  • YP yoga practitioners
  • S.D. standard deviation
  • N.S. non-significant
  • CSQ-Cat Coping Strategies Questionnaire- Catastrophizing
  • FIQ Fibromyalgia Impact Questionnaire
  • STAI State-Trait Anxiety Inventory. [00112] Box plots reveal the value distributions for skin conductance ( Figure 1 1A) and pain ratings (Figure 1 IB) in response to high pressure stimulation for each group at each certainty/uncertainty level. SCR and pain ratings for FM were highest for the Even Odds (uncertain) condition, while the highest values for both HV and YP were found for the High Odds condition. HV had considerable individual variation in values on both measures, particularly for the Even Odds condition, indicating high group heterogeneity.
  • Table 2 provides model estimated marginal means and standard errors for SCR for the group-by- condition-by-stimulus interaction.
  • Figure 12A shows the pattern of mean SCR responses, adjusted for all other effects, for FM, HV, and YP for the three stimulus conditions.
  • SCR responses should show a linear trend having its high point at High Odds (more high than low pressure stimuli), midpoint for Even Odds (equal numbers of high and low pressure stimuli), and low point for Low Odds (more low than high pressure stimuli). If participants responded more to the effects of uncertainty, SCR responses should show a nonlinear pattern, with the highest response occurring for the uncertain condition.
  • HV pain ratings appear higher overall compared to the other groups with a slight linear decrease from High Odds through Uncertain to Low Odds.
  • YP pain ratings appear highest for High Odds but considerably lower for both Uncertain and Low Odds conditions.

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Abstract

L'invention porte sur un système d'évaluation de lésion de nerf périphérique chez un sujet. Le système comprend un dispositif d'application de pression et un ordinateur. Le système applique une pression sur une partie de corps sélectionnée d'un sujet dans un motif désiré et poursuit l'application de pression jusqu'à ce qu'un seuil de douleur pour le sujet soit atteint.
PCT/US2012/023761 2011-02-03 2012-02-03 Dispositifs, systèmes et procédés d'évaluation de lésion de nerf périphérique Ceased WO2012106593A2 (fr)

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WO2014150345A1 (fr) * 2013-03-15 2014-09-25 First Principles, Inc. Système et procédé pour la commande par un signal biologique d'un dispositif électronique
EP2967354A4 (fr) * 2013-03-15 2017-05-31 Adam J. Simon Évaluation pharmaco-diagnostique multimodale de la santé cérébrale
US10022090B2 (en) 2013-10-18 2018-07-17 Atlantic Health System, Inc. Nerve protecting dissection device
WO2019234292A1 (fr) 2018-06-08 2019-12-12 Icare Finland Oy Système pour déterminer un seuil de sensibilité tactile
US10779747B2 (en) 2013-03-15 2020-09-22 Cerora, Inc. System and signatures for the multi-modal physiological stimulation and assessment of brain health
WO2021032320A1 (fr) * 2019-08-20 2021-02-25 David Boeger Appareil pour influencer un tissu corporel, procédé pour mesurer et évaluer un état de tissu corporel
US11166672B2 (en) 2013-10-18 2021-11-09 Atlantic Health System, Inc. Nerve protecting dissection device
EP4104753A1 (fr) * 2021-06-18 2022-12-21 5010889 Ontario Inc. Dispositif de mesure de la sensibilité d'un sujet
CN116725686A (zh) * 2023-04-12 2023-09-12 珠海横乐医学科技有限公司 穿刺手术机器人及其控制方法、控制器、存储介质

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US4878841A (en) * 1986-06-19 1989-11-07 Mcculloch Christopher A G Periodontal probe
KR100493157B1 (ko) * 2002-08-02 2005-06-03 삼성전자주식회사 생체신호 측정에 사용되는 프로브 및 이를 포함하는생체신호 측정용 시스템
US8961428B2 (en) * 2008-11-05 2015-02-24 Ian James Spruce Force transducer, medical instrument, and machine implemented method
US8412295B2 (en) * 2009-03-31 2013-04-02 Covidien Lp Systems and methods for monitoring pain management
US9307906B2 (en) * 2009-10-02 2016-04-12 The Regents Of The University Of Michigan Multimodal automated sensory testing system

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WO2014150345A1 (fr) * 2013-03-15 2014-09-25 First Principles, Inc. Système et procédé pour la commande par un signal biologique d'un dispositif électronique
EP2967354A4 (fr) * 2013-03-15 2017-05-31 Adam J. Simon Évaluation pharmaco-diagnostique multimodale de la santé cérébrale
US10779747B2 (en) 2013-03-15 2020-09-22 Cerora, Inc. System and signatures for the multi-modal physiological stimulation and assessment of brain health
US10022090B2 (en) 2013-10-18 2018-07-17 Atlantic Health System, Inc. Nerve protecting dissection device
US11166672B2 (en) 2013-10-18 2021-11-09 Atlantic Health System, Inc. Nerve protecting dissection device
WO2019234292A1 (fr) 2018-06-08 2019-12-12 Icare Finland Oy Système pour déterminer un seuil de sensibilité tactile
US20210251569A1 (en) * 2018-06-08 2021-08-19 Icare Finland Oy Method and system for determining touch sensitivity threshold
US12186093B2 (en) * 2018-06-08 2025-01-07 Icare Finland Oy Method and system for determining touch sensitivity threshold
WO2021032320A1 (fr) * 2019-08-20 2021-02-25 David Boeger Appareil pour influencer un tissu corporel, procédé pour mesurer et évaluer un état de tissu corporel
EP4104753A1 (fr) * 2021-06-18 2022-12-21 5010889 Ontario Inc. Dispositif de mesure de la sensibilité d'un sujet
CN116725686A (zh) * 2023-04-12 2023-09-12 珠海横乐医学科技有限公司 穿刺手术机器人及其控制方法、控制器、存储介质

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