WO2020006048A1 - Stimulation multimodale de traitement des tremblements - Google Patents

Stimulation multimodale de traitement des tremblements Download PDF

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Publication number
WO2020006048A1
WO2020006048A1 PCT/US2019/039193 US2019039193W WO2020006048A1 WO 2020006048 A1 WO2020006048 A1 WO 2020006048A1 US 2019039193 W US2019039193 W US 2019039193W WO 2020006048 A1 WO2020006048 A1 WO 2020006048A1
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WO
WIPO (PCT)
Prior art keywords
stimulation
location
tremor
applying
nerve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2019/039193
Other languages
English (en)
Inventor
Kathryn H. ROSENBLUTH
Scott Lee DELP
John Paderi
Vijaykumar Rajasekhar
Tahel ALTMAN
Samuel Richard HAMNER
Erika Kristine ROSS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cala Health Inc
Original Assignee
Cala Health Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/020,876 external-priority patent/US12453853B2/en
Application filed by Cala Health Inc filed Critical Cala Health Inc
Priority to CN201980055793.8A priority Critical patent/CN112601488A/zh
Priority to EP19825339.5A priority patent/EP3813647A4/fr
Publication of WO2020006048A1 publication Critical patent/WO2020006048A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645—Applicators worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0021—Neural system treatment
    • A61N2007/0026—Stimulation of nerve tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0086—Beam steering
    • A61N2007/0095—Beam steering by modifying an excitation signal

Definitions

  • the first stimulus has an amplitude that is less than about 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1 mA (e.g., between about 0.1 mA and about 1 mA, between about 0.1 mA and about 2 mA, between about 0.1 mA and about 3 mA, between about 0.1 mA and about 4 mA, between about 0.1 mA and about 5 mA, between about 0.1 mA and about 6 mA, between about 0.1 mA and about 7 mA, between about 0.1 mA and about 8 mA, between about 0.1 mA and about 9 mA, between about 0.1 mA and about 10 mA, between about 0.1 mA and about 11 mA, between about 0.1 mA and about 12 mA, between about 0.1 mA and about 13 mA, between about 0.1 mA and about 14 mA, between about 0.1 mA and about 15 mA, or other
  • the first stimulus comprises vibrotactile.
  • the first stimulus comprises chemical.
  • a first stimulus comprises mechanical, vibrational, electromechanical, thermal, radiant, electrical, magnetic, electromagnetic, light, acoustic, ultrasonic (e.g., focused ultrasound), chemical, infrared, radiofrequency (RF), ultraviolet, x-ray, or microwave.
  • a second or third stimulus is the same as the first stimulus, but at a different location on the body.
  • a second or third stimulus is different from the first stimulus, and at the same or different location on the body. For example, a first stimulus is applied to the wrist and a second, different stimulus is applied at a different location.
  • a multi-modal approach offers a 10-75% reduction in the time it takes to reach efficacy (e.g., a reduction in tremor) or a 10-75% increase in the length of therapeutic effect as compared to a single mode approach or no treatment.
  • a multiple modal approach may reduce tremor during the stimulation and for a period of 30 minutes, 1-2 hours and 6 hours, or longer, post stimulation. Stimulation is provided one, two, three, four, five, or more times per day in some embodiments.
  • a multi-modal optimized approach in which feedback is used is provided in several embodiments.
  • the first location and second location are located on adjacent fingers.
  • the first peripheral nerve and the second peripheral nerve are adjacent nerves.
  • the first peripheral nerve is the median nerve and the second peripheral nerve is the ulnar or radial nerve.
  • the first peripheral nerve and the second peripheral nerve are somatotopically adjacent.
  • the device can include a decision unit; and an interface unit adapted to deliver electrical stimuli to a peripheral nerve, the interface unit comprising a first peripheral nerve effector in communication with the decision unit, the first peripheral nerve effector comprising at least one electrode; wherein the decision unit comprises a processor and a memory storing instructions that, when executed by the processor, cause the decision unit to: deliver a first electrical stimulus to a first peripheral nerve through the first peripheral nerve effector, the electrical stimulus configured by the controller to reduce tremor or other dysfunction in the patient’s extremity by modifying the patient’s neural network dynamics.
  • the two modes are the same (e.g., the same location, both electrical stimulation, both excitatory, both inhibitory, etc.). Three, four or more modes may be used in some embodiments.
  • overactive bladder and cardiac dysfunction are treated.
  • Psychiatric disorders e.g., with neurotransmission dysfunction
  • the parameter may comprise at least one of stimulation frequency, amplitude, pulse width, pulse spacing, phase, waveform shape, waveform symmetry, duration, duty cycle, on/off time, or bursting.
  • the parameter may comprise stimulation continuousness.
  • the first stimulation mode may comprise burst.
  • the second stimulation mode may comprise continuous.
  • the parameter may comprise stimulation frequency.
  • the first stimulation mode may comprise between 10 Hz and 30 Hz (e.g., 20 Hz).
  • the second stimulation mode may comprise between 30 Hz and 50 Hz (e.g., 40 Hz).
  • the first stimulation mode may comprise between 100 Hz and 200 Hz (e.g., 150 Hz).
  • the second stimulation mode may comprise between 50 Hz and 150 Hz (e.g., 100 Hz).
  • the first and second stimulation may burst on/off in an alternating pattern at a frequency between 4-12 Hz, for example in a burst mode; e.g., 10 Hz).
  • the parameter may comprise a stimulation waveform.
  • the first stimulation mode may comprise a first stimulation waveform.
  • the second stimulation mode may comprise a second stimulation waveform different than the first stimulation waveform.
  • At least one of the first stimulation actuator or the second stimulation actuator may comprise a thermal device, component, actuator, or portion that increases and/or decreases internal temperature of surrounding tissue (such as means for heating and/or cooling (e.g., resistive heaters, piezoelectric cooler, fluid based temperature control) including for example an element, device, mechanism, component, portion, affector, or the like).
  • the thermal device may be configured to apply a cooling effect.
  • the thermal device may be configured to apply a heating effect.
  • Temperature sensors may also be included and provide communication to the processor or controls module, with or without feedback that affects the cooling or heating.
  • At least one of the first stimulation actuator or the second stimulation actuator may comprise a chemical (e.g., pharmacological therapy or lidocaine). At least one of the first stimulation actuator or the second stimulation actuator may comprise an ultrasonic (e.g., focused ultrasound) actuator (such as means for generating ultrasonic energy (e.g., a transducer, piezoelectric element, coupling fluid) including for example an element, device, mechanism, component, portion, affector, or the like). At least one of the first stimulation actuator or the second stimulation actuator may comprise a microwave actuator (such as means for generating microwave energy (e.g., a microwave generator) including for example an element, device, mechanism, component or portion affector, or the like). In some embodiments, at least one of the first stimulation actuator or the second stimulation actuator comprises an electromagnetic actuator for generating electromagnetic energy, waves, fields, etc. In addition to a second stimulation actuator, a third, fourth or additional stimulation actuator is used in some embodiments.
  • an ultrasonic actuator e.g., focused ultrasound
  • the first stimulation actuator may comprise an electrode (e.g., 1-6, or more electrodes).
  • the electrode may be transcutaneous or subcutaneous.
  • a system and method of treating tremor or other indication in a subject comprises applying a first stimulation to a first peripheral body part and applying a second stimulation to a second peripheral body part different than the first peripheral body part.
  • the first stimulation comprises at least one of electrical stimulation, vibrational stimulation, thermal stimulation, or chemical stimulation.
  • the second stimulation comprises at least one of electrical stimulation, vibrational stimulation, thermal stimulation, or chemical stimulation. The second stimulation is different than the first stimulation.
  • the first and second (and optionally third, fourth or more) stimuli comprise mechanical stimulation.
  • the stimuli have different vibration durations and/or frequencies.
  • a mechanical actuator is activated to apply controlled pressure to a specific location, such as a target nerve or acupressure point.
  • the mechanical actuator can comprise a linear actuator or a rotational actuator that displaces tissue in the proximity of a nerve to apply pressure to activate proprioceptors in a target region or in a target nerve.
  • the first and second (and optionally third, fourth or more) stimuli comprise different stimuli at different points in the same region.
  • electrical stimulation at a certain frequency, duration and/or amplitude is applied at a first point and electrical stimulation at a different frequency, duration and/or amplitude is applied at a second point.
  • the two points may be on the wrist at different places, and may stimulate the same or different nerves.
  • the stimuli may be simultaneous and/or sequential, or overlapping.
  • the stimuli may be patterned across a plurality of electrodes arranged linearly or circumferentially in a band or over skin interface.
  • a tri-modal approach is also used in one embodiment, in which, for example, three points on a wrist are stimulated.
  • the treatment points may be on an ankle, knee, thigh, upper arm, finger, toe, ear, chest, back, shoulder, head, neck, etc.
  • both electrical and mechanical are provided sequentially and/or simultaneously in a multi-modal dual approach.
  • the dual stimulation is provided at the same location (e.g., same point on the wrist).
  • the dual stimulation is provided in the same region but at different points (e.g., different points on the wrist).
  • the dual stimulation is provided at different regions (e.g., the wrist and the ankle).
  • Third, fourth or additional stimuli are provided in some embodiments.
  • a first stimulation is applied to a first location
  • a second stimulation is applied to a second location
  • a third stimulation is applied to a third location
  • a fourth stimulation is applied to a fourth location.
  • one or more locations are different than the others.
  • a method of treating tremor in a subject comprises applying a first stimulation from a first actuator to a first location on a body of the subject and applying a second stimulation from a second actuator.
  • the first stimulation comprises electrical stimulation.
  • the first actuator comprises an electrode.
  • the second stimulation comprises vibratory stimulation.
  • the first actuator and the second actuator are coupled to one of the arm, wrist, leg, knee, or ankle using a flexible cuff.
  • At least one of applying the first stimulation or applying the second stimulation is responsive to a controller in a smart device and based on a sensed and predetermined characteristic of the disease. After applying the first stimulation and applying the second stimulation, the symptom of the disease is reduced.
  • FIG. 1 illustrates one embodiment of delivering stimulation to the median nerve found to reduce tremor.
  • FIG. 4 illustrates an example of ineffective treatment in a moderate ET patient.
  • FIG. 9A is a diagram showing an embodiment of an excitation scheme to dephase the brain regions receiving sensory input from two fingers.
  • FIG. 22 is a flowchart showing the feedback logic.
  • These access points can include, but are not limited to, the fingers 510 including one or more fingers and/or the thumb, the hand 520, the wrist 530, the lower arm or forearm 540, the elbow 550, the upper arm 560, the shoulder 570, the spine 580 or the neck 590, foot (including one or more toes for example), ankle, lower leg or calf, knee, and/or upper leg or thigh.
  • These access points may be used for direct stimulation in some embodiments. In other embodiments, these access points are used for indirect stimulation. Both indirect and direct stimulation are provided in several embodiments. Two, three or more access points are provided in some embodiments.
  • Nerves affecting proprioception can include, for example, the median, ulnar, radial, or other nerves in the hand, arm, and spinal area, or along muscle or within joints. These regions target to the nerves may include the brachial plexus, medial nerves, radial nerves, and ulnar, dermal, or joint space nerves. These regions may also target the musculature including muscles of the shoulder, muscles of the arm, and muscles of the forearm, hand, or fingers. Muscles of the shoulder may include, by non-limiting example, the deltoid, teres major and supraspinatus. Muscles of the arm may include the coracobrachialis and triceps brachii.
  • Some examples of device locations or treatment sites that may be used in combination include two or more of wrist, hand, finger, forearm, upper arm, elbow, shoulder, arm, ankle, foot, toe, calf, lower leg, thigh, upper leg, knee, leg, upper body appendage, upper body, lower body appendage, lower body, spine, neck, head, or a portion of any of these.
  • a plurality of sites may be combined with a plurality of modalities and/or a plurality of modes, each modality having a plurality of modes or one or more modalities having different modes. For example, a first stimulation modality and/or mode can be applied to the wrist 530 and a second stimulation modality and/or mode can be applied to the finger 510.
  • thermal energy is increased or decreased in the surrounding tissue in contact with the device.
  • Thermal energy can be increased in tissue contacting the device by a thermoelectric heating element (for example, a battery disposed in the device with a resistive element). The heat can be transferred to specific target locations in the band, for example, that have conductive elements that transfer the thermal energy to tissue in contact with the conductive elements.
  • Thermal energy can be decreased in tissue contacting the device by a thermoelectric cooling element (for example, a Peltier device or solid state refrigerator) or by circulating a coolant or cooling liquid through a part of the device in contact with the target tissue area (for example, in a wrist worn device the band may be disposed with tubing to circulate a cooling liquid through the band).
  • Pacinian corpuscles provide information about touch; Muscle spindles provide information about changes in muscle length by triggering action potentials in the muscle spindle afferent nerve when mechanically-gated ion channels open due to muscle stretching; Golgi tendon organs provide information about muscle tension. These structures may also be stimulated to alter circuit dynamics and reduce tremor.
  • FIGS. 7A-7D are conceptual diagrams illustrating some embodiments of a tremor altering system 700.
  • System 700 includes a housing 720, one or more effectors 730, one or more controls 740 in electrical communication with the effector 730, and one or more power sources 750.
  • the housing 720 can, in some embodiments, include an interface 760.
  • the interface facilitates the coupling of the effector to the patient.
  • the interface can provide a physical, electrical, chemical, thermal or magnetic connection between the device and the patient’s nerve.
  • the housing 720 can also, in some embodiments, include a sensor 780 to detect the tremor, memory 770, display 790, and processor 797.
  • the interface unit 704 is an implant; the effector 730 provides electrical stimulation of the nerves; the instruction set and power are transmitted wirelessly from an external device.
  • the implanted interface unit 704 may be powered with an on-board battery.
  • the implanted interface unit 704 may contain a sensor 780 for direct detection of the tremor or neuromuscular activity detected by electroneurography (ENG) or electromyography (EMG).
  • ENG electroneurography
  • EMG electromyography
  • one or more sensor units 780, sensing motion, temperature, etc. may be worn at different locations in the body.
  • the effector 730 and decision unit 702 are a separate entity worn at a different location on the body than the sensors 780. This is useful if stimulation of a nerve occurs in a location where tremor is not as easily or accurately measured. For instance, a stimulation device 700 placed on the underside of the wrist for reducing hand tremor is highly effective.
  • the stimulation parameters may be adjusted automatically, or controlled by the user.
  • the stimulation parameters may include on/off, time duration, intensity, pulse rate, pulse width, waveform shape, and the ramp of pulse on and off.
  • the pulse rate may be approximately 50 to 5000 Hz, and a preferred frequency of about 50 Hz to 300 Hz, or 150 Hz.
  • a preferred pulse width may range from 50 to 500 ps (micro-seconds), and a preferred pulse width may be approximately 300 ps (e.g., about 50 ps, about 100 ps, about 150 ps, about 200 ps, about 250 ps, about 300 ps, about 350 ps, about 400 ps, about 450 ps, about 500 ps, and ranges between such values).
  • the intensity or amplitude of the electrical stimulation may vary from 0 mA to 500 mA, and a preferred current may be approximately 1 mA to 6 mA (e.g., about 0 mA, about 0.1 mA, about 1 mA, about 6 mA, about 10 mA, about 20 mA, about 30 mA, about 40 mA, about 50 mA, about 100 mA, about 200 mA, about 300 mA, about 400 mA, about 500 mA, and ranges between such values). Certain preferred settings are derived from the clinical study described above that provided a valuable reduction in tremor sustained for a time period. Electrical stimulation can be adjusted in different patients and with different methods of electrical stimulation.
  • the function generator is preferably an arbitrary waveform generator that uses direct digital synthesis techniques to generate any waveform that can be described by a table of amplitudes.
  • the parameters are selected from a group including but not limited to frequency, intensity, pulse width or pulse duration, and overall duration.
  • the outputs preferably have a power limit set by the maximum output voltage.
  • the digitally stored protocols cycle through various stimulation parameters to prevent patient acclimation. Variation of electrical stimulation is achieved by the function generator.
  • Amplitudes of the sweeps could be enveloped by other waveforms, such as sinusoid or Gaussian curve, or the parameters could be changed randomly or pseudo-randomly. Discussions of different frequencies above can also apply to other parameters such as frequency, amplitude, pulse width, pulse spacing, phase, waveform shape, waveform symmetry, duration, duty cycle, on/off time, or bursting, combinations thereof, and the like.
  • FIG. 8A is a diagram showing a preferred embodiment of the device, in which anode 810 and cathode 820 electrode pairs on the fingers are used to excite the branches of the proprioceptive nerves (the median, radial and ulnar nerves) in each finger.
  • This arrangement of anode 810 being distal and cathode 820 being proximal is designed to induce a nerve pulse traveling towards the brain.
  • a unique stimulation pattern on each finger can send a unique signal to a specific subpopulation of neurons in the brain because of the somatotopic organization of the brain, in which signals from different adjacent or nearby body parts synapse at nearby locations in the brain.
  • the stimulation waveform may be very high frequency, typically in the kHz and above, such that the stimulation is not felt by the user, or it is felt very little.
  • Very high frequency stimulation is thought to make a conduction blockade. However, prior to the blockade there is an onset response including a strong depolarization of the nerve. To effectively implement very high frequency stimulation without causing discomfort for the patient, it would be preferable to eliminate this onset response. This can be done by cooling the nerve during the initial stimulation. Motor nerves are generally excited by stimulation at about 15 Hz and below, while sensory nerves are generally excited by stimulation at about 50 Hz and above. In some embodiments, it may be desirable to specifically stimulate above the 15 Hz threshold of motor neuron stimulation to avoid causing muscle contraction.
  • the vibratory stimulus comprises a combination of one or more single frequencies and one or more sweep frequencies (e.g., continuously changing from a lower frequency to a higher frequency).
  • a first single frequency can be applied for a first duration and a first sweep frequency can be applied for a second duration.
  • the second duration may be after (e.g., immediately after, after a pause duration) the first duration.
  • the second duration may at least partially overlap the first duration.
  • a second single frequency different than the second frequency can be applied for a third duration.
  • the third duration may be after (e.g., immediately after, after a pause duration) the second duration.
  • the third duration may at least partially overlap the second duration.
  • Temperature sensors may function to detect the effective cooling temperature in an embodiment where the stimulator is a thermal stimulator. Effective cooling or heating temperature may be the temperature felt by the user, and this is not necessarily the same as the applied temperature. If the temperature sensors determine that the effective temperature reaches a threshold, which may range from 5 degrees C greater or less than the applied temperature for a particular protocol, the processor 797 (from FIG. 7) may modify said protocol to cool or heat more than originally programmed to compensate for the discrepancy between effective and intended cooling.
  • a magnet may comprise an electromagnet comprising a material that only becomes magnetic upon the application of a current to a wire wrapped around the magnet to create a magnetic field that can multiply the magnetic field strength of the material.
  • the magnetic effector can be turned on and off without moving the effector.
  • vibrational stimulation is used in combination with electrical stimulation.
  • vibration and electrical stimulation are in the same location or in different locations.
  • vibrational stimulation is used to preferentially stimulate proprioceptors (e.g., A-fibers) and electrical stimulation is used to preferentially stimulate a different type of sensory fiber, such as pain or touch sensory fibers (e.g., C-fibers), or vice-versa.
  • proprioceptors e.g., A-fibers
  • electrical stimulation is used to preferentially stimulate a different type of sensory fiber, such as pain or touch sensory fibers (e.g., C-fibers), or vice-versa.
  • the second stimulation mode may comprise between 50 Hz and 150 Hz (e.g., 100 Hz).
  • the first and second stimulation may burst on/off in an alternating pattern at a frequency between 4-12 Hz, for example in a burst mode; e.g., 10 Hz).
  • a first stimulation can comprise a first waveform and a second stimulation can comprise a second waveform different than the first waveform.
  • different stimulation parameters are used in the same region at the same nerve bundle, in the same region but at different nerve bundles (e.g., different points), and/or at different locations.
  • the overall shape of the aligning piece can align the interface in the final dimension, which in this particular example of embodiment is the depth.
  • the housing can have a matching feature of this shape for which the connection can connect to. It is possible that the connection feature can be reversed and the aligning piece be placed on the housing, and the matching feature of shape be placed on the interface.
  • These connections of the aligning piece can possibly have or not have magnets on one, both or none of the housing or interface components.
  • another preferred embodiment may comprise a stimulation device with one or more electrodes 1460 applied along the spine.
  • the stimulation device may function to stimulate the release of neurotransmitters and reduce tremor through neuromodulation of the nerves located along the spine. Stimulation may affect the release and uptake of neurotransmitters, thereby affecting the nerves innervating the tremulous regions.
  • the electrodes are preferably placed on the dermal surface at the cervical spine roots, preferably from Cl to C8 but most preferably between C5 and C8.
  • the electrodes are preferably patch electrodes.
  • the operating unit is preferably affixable to the user and the leads connecting the electrodes to the operating unit are preferably magnetized for easy connection. The operating unit may be connected to and controlled by the processor. Since the electrodes are preferably placed along the spine (back side of the user), a detached and portable controls module may be more convenient for a user to operate.
  • the electrodes may be placed on either side of the spine around C2 to C8 region of the neck and shoulders.
  • the electrodes may be placed approximately 100 cm to lcm away from the spine, and may be placed 200 cm to 5 cm apart from each other.
  • the stimulation parameters may include a phase duration of between 500 and 30 pseconds, which may preferably be 300-60 pseconds (micro-seconds).
  • the pulse rate may range from 10 Hz to 5000 Hz or higher (e.g., 20 kHz), and the preferable range may be 50 Hz to 200 Hz, or 150 Hz.
  • the cycle time may be continuous, or may range from 5 seconds to 1 hour.
  • the preferable cycle time may be approximately 5 seconds to 20 seconds, or 10 seconds.
  • electrical stimulation from a poorly positioned electrode may be redirected to the target nerve by modifying the conduction pathway between the electrode and the target nerve.
  • a conduction pathway enhancer 1600 which can be made from a conductive material, can be placed on the patient’ s skin, embedded into the skin, implanted, or a combination of the above, in order to enhance the conduction of the electrical stimulus from the electrode 1602 to the target nerve 1604, as illustrated in FIGS. 16A-16D.
  • the conduction pathway enhancer may be placed over the nerve and/or across the nerve.
  • a tattoo of conductive ink may direct off-target stimulation towards the median nerve.
  • a wearable device should be discrete and comfortable.
  • the effector is electrical and the skin patch has a single electrode or plurality of electrodes electronics printed onto a flexible substrate in a predetermined pattern to make a“second-skin”, similar to a bandaid.
  • the mechanical characteristics such as the elasticity and stiffness should be matched to the skin.
  • the circuitry and wiring for surface electrical stimulation may be printed or etched into a flexible material such that the device conforms to the body or to tissue within the body. For example, it may be copper printed on a flexible substrate such as plastic.
  • Customized treatment based on feedback and/or algorithms are provided in several embodiments.
  • the 2102 stimulation history may be collected such that the analysis may examine the relationship between the stimulation history and the tremor characteristics.
  • FIG. 21D shows how the data monitoring and analysis shown in FIGS. 21A- C may be used in a closed loop to adjust the stimulation parameters. In this way, the algorithms detect interactions between the variables to optimize the therapy.
  • access to the data is restricted to the health care providers and the patient. Access can be limited by requiring users to set up a secure username and password to access the data. In some embodiments, the patient can also provide others, such as family and friends, with access to the data.
  • the effector may be electrically coupled to one or more power sources, as illustrated in FIGS. 7A-7D for example.
  • the power source 750 functions to power the device.
  • the power source 750 may be connected to the processor 797 and provide energy for the processor to run.
  • the power source may preferably be rechargeable and detachable as this allows the device to be reused.
  • the power source may preferably be a battery.
  • Several different combinations of chemicals are commonly used, including lead-acid, nickel cadmium (NiCd), nickel metal hydride (NiMH), lithium ion (Li-ion), and lithium ion polymer (Li-ion polymer).
  • a special charging station or dongle could be used to recharge the device.
  • the benefit of the special charging station is that it could also facilitate the upload of data from the device to the web via Wifi or another communication protocol.
  • the method of stimulating peripheral nerves to control hand tremors introduces specific requirements for an appropriate implanted stimulator.
  • the implant should be small to minimize the invasiveness of the procedure used to position the implant and make it appropriate for implantation.
  • the stimulation may be responsive to the detected tremor or user input, the implant should be capable of receiving communication from an external device.
  • the device should tolerate variability in the positioning of the external device.
  • the housing, interface, effector and power source are implanted and the controller is external to the patient.
  • the controller may be, for example, in wireless communication with the effector.
  • the power source is external to the patient.
  • the device may contain further elements which may include a processor 797 that performs computations and controls other components; a processor controlled function generator; a digital library 799 stored on the processor or memory which contains preloaded modulation protocols; a sensor 780 connected to or in communication with the processor 797 which detects predefined parameters and transmits that parameter information to the processor; a data storage unit 770 connected to the sensor and processor; and a power supply 750.
  • a processor 797 that performs computations and controls other components
  • a processor controlled function generator e.g., a processor controlled function generator
  • a digital library 799 stored on the processor or memory which contains preloaded modulation protocols
  • a sensor 780 connected to or in communication with the processor 797 which detects predefined parameters and transmits that parameter information to the processor
  • a data storage unit 770 connected to the sensor and processor
  • a power supply 750 e.g., a power supply 750.
  • the implanted electrodes 2310 may function to provide direct electrical stimulation to the targeted nerves. Since the electrodes are implanted at least partially into the body and will remain an extended period of time (preferably several years), the electrodes may be made of material that has suitable electrical properties and is biocompatible.
  • the electrode 2310 material is preferably selected from a group including silicones, PTFE, parylene, polyimide, polyesterimide, platinum, ceramic, and gold, or of natural materials such as collagen or hyaluronic acid.
  • the electrodes 2310 can be of varying shape and size but importantly contact the nerves of interest. Electrode shapes include planar shanks, simple uniform microwires, and probes that taper to a thin tip from a wider base.
  • the method of inserting the implant may involve local or general anesthesia.
  • the implant may be delivered through one or more punctures in the skin, such as a needle or suture, or it may be an open incision made in the skin to access the target area, or it could include both methods.
  • the device may be implanted by threading all or part of the device around the nerve and or surrounding tissue, such as blood vessels or tendons.
  • the device or devices used to place the device may use ultrasound for guidance. Ultrasound may be used to measure proximity to blood vessels, nerves or other tissues, or to characterize the type and location of adjacent tissues.
  • the electrodes for stimulation may be injected as a liquid.
  • the electrodes may be flexible and delivered in a viscous medium like hyaluronic acid.
  • the electrodes may be made of nitinol that takes its shape at 37 degrees Celsius. This would permit injecting or inserting the electrodes in one configuration, such as an elongated configuration to fit in a needle, and then would take their form when warmed to body temperature. Some of these examples are depicted in FIG. 25.
  • Transcutaneous charging or powering reduces the implant size by eliminating the need for a large power source (e.g., battery) and eliminates the need to replace the power source with repeat surgeries.
  • An external component may be used to wirelessly power the internal component, such as by radiofrequency (RF) power transfer.
  • the external device may emit RF power that the internal component receives with a resonant coil.
  • the power may be transmitted at a variety of wavelengths, including but not limited the radiofrequency and microwave spectrums, which range from 3 kHz to 300 GHz.
  • the internal device may contain a battery.
  • the external device may be worn or carried on the body, or it may be in the nearby surroundings such as on a nearby table or wall. It may be portable or fixed.
  • the stimulation can target one, two, three, or more nerves associated with bladder function.
  • the nerves can include, for example, the tibial nerve or posterior tibial nerve, which can branch into the medial and lateral plantar nerve branches, and the calcaneal nerves.
  • the saphenous nerve is the cutaneous branch of the femoral nerve.
  • Other nerves include, for example, the pudendal nerve, pelvic nerve, dorsal genital nerve, external anal sphincter nerve, and the dorsal genital nerve, for example.
  • waveforms including those described herein can be modified over time in order to minimize certain effects, such as habituation.
  • One way of decreasing habituation is to modify the frequency, pulse width, amplitude, duty cycle, phase, waveform shape, waveform symmetry, pulse spacing, duration, on/off time, or bursting pattern of the stimulation.
  • randomizing or pseudo-randomizing parameters such as, for example, the frequency or pulse width can reduce habituation.
  • Using a Gaussian distribution for randomization can be effective in some cases, and used in such waveforms as stochastic waveforms.
  • Another way of reducing habituation is to the lower the frequency below a certain threshold, such as, for example, no more than about 60Hz, 55Hz, 50Hz, 45Hz, or 40Hz, in which humans tend not to habituate.
  • these biological measures can be analyzed to assess the wearer’s activity state, such as sedentary versus active, level of stress and/or bladder fluid volume, and the like, which in turn, can serve as a predictor for increases in urinary and/or gastrointestinal urgency.
  • the points to be stimulated include BL18, BL23, BL28, and CV2. In some embodiments, the points to be stimulated include ST28, SP6, BL23, BL28, BL32, BL33, BL53, CV3, and N-BW-38. In some embodiments, the points to be stimulated include SP6, BL23, BL27, BL28, BL33, and CV4. In some embodiments, the points to be stimulated include SP9, LR1, LR2, CV4, and CV6. In some embodiments, the points to be stimulated include SP6, SP9, BL23, CV3, and CV6. In some embodiments, the points to be stimulated include SP9 and GB34.
  • the multi-modal stimulation involves patterns of electromagnetic stimulation of peripheral nerves.
  • the patterned stimulation could be a bursting stimulation, such as an on/off pattern that repeats at regular intervals (e.g., on for lOms, off for 20ms, etc.), or non-burst patterned stimulation that can be more complex in some embodiments, such as a stochastic pattern or a sinusoidal envelope for example.
  • the electromagnetic stimulation could include, for example, electrical energy, mechanical energy (e.g., vibration), magnetic energy, ultrasonic energy (e.g., focused ultrasound), radiofrequency energy, thermal energy, light energy (such as infrared or ultraviolet energy for example), and/or microwave energy, or combinations thereof.
  • Burst stimulation of peripheral nerves, including afferent nerves can in some cases deliver a more efficacious therapy by remotely accelerating plasticity of one or more central nervous system (e.g., brain and/or spinal cord) circuits, in other words creating plasticity in neural circuits for a period of time that is far longer than the duration of the stimulation session, such as, for example, about or at least about 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, or even longer.
  • Peripheral stimulation in some cases can be more convenient and comfortable for the user than central stimulation (e.g., transcranial stimulation and/or spinal stimulation) and can be more suitable for home and ambulatory use.
  • Receiving an input relating to autonomic nervous system activity of the patient can include any number of the following: receiving data from a sensor that measures autonomic nervous system activity of the patient; receiving data from a sensor that measures heart rate variability of the patient; receiving heart rate variability data from an optical sensor measuring blood flow characteristics and disposed proximate a vessel proximate a knee of the patient; receiving data from a sensor that measures galvanic skin response of the patient; receiving data relating to urinary and/or gastrointestinal symptoms of the patient; and/or receiving data relating to nocturia episodes of the patient.
  • a multi-modal wearable device for dual stimulation of the saphenous nerve and posterior tibial nerve and for treating urinary and/or gastrointestinal symptoms in a patient.
  • the device can include, in some embodiments, any number of the following features: a controller; a first peripheral nerve effector configured to be positioned to transcutaneously modulate the saphenous nerve; a second peripheral nerve effector configured to be positioned to transcutaneously modulate the posterior tibial nerve; and at least one biomedical sensor or data input source configured to provide feedback information.
  • multi-modal stimulation can invoke a neurohormonal response by myofascial or cutaneous stimulation of acupressure points in the upper and lower extremities, such as Ht7, Pc6, Gb34, Sp6, Ki6, etc.
  • Neurohormonal responses can include changes (increase or decrease) in production of norepinephrine, epinephrine, acetylcholine, and/or inflammatory cytokines.
  • Inflammatory cytokines can include interleukin, high-mobility group-box 1 protein, and/or tumor necrosis factor alpha.
  • multi-modal stimulation of peripheral nerves can reduce sporadic electrical activity of the pulmonary veins, which trigger and maintain cardiac dysrhythmias.
  • arrhythmias that can be treated using systems and methods as disclosed herein can include, for example, long QT syndrome, torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex, premature ventricular contractions, accelerated idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, and ventricular fibrillation.
  • long QT syndrome torsades de pointes, premature atrial contractions, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), AV nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, premature junctional complex,
  • a cardiac glycoside such as digoxin can be administered orally, intravenously, or another route along with peripheral nerve stimulation protocols such as described herein for an unexpected synergistically beneficial effect in treating cardiac arrhythmias, cardiac dyssynchrony, and/or hypertension.
  • digitalis glycosides and cardiac glycosides sometimes referred to as digoxin or deacetyllanatoside C, can modulate arterial baroreflex mechanisms in humans.
  • a diminishing of the barorecptor reflex can lead to continuous and excessive sympathetic activity, which in turn can lead to an increase in heart rate, blood pressure, and the initiation and maintenance of cardiac dysrhythmias.
  • the dose of cardiac glycoside, such as digoxin, administered to the patient can be much less than conventionally prescribed, such as about or less than about 3, 2.8, 2.6, 2.4, 2.2, 2.0, 1.8, 1.6, 1.4, 1.2, 1.0, 0.8, 0.6, 0.4 or 0.2 mcg/kg per day.
  • the devices disclosed herein are used to stimulate two nerves (including but not limited to the median, radial, ulnar, or median cutaneous nerve) located at a distance from the brachial plexus at two different times, wherein, ultimately, the brachial plexus is stimulated by both signals from two or more nerves substantially simultaneously (e.g., less than about 2 ms, 1 ms, 0.5 ms, 0.4 ms, 0.3 ms, 0.2 ms, 0.1 ms, 0.09 ms, 0.08 ms, 0.07 ms, 0.06 ms, 0.05 ms, 0.04 ms, 0.03 ms, 0.02 ms, 0.01 ms, or less), but could be higher in some cases.
  • two nerves including but not limited to the median, radial, ulnar, or median cutaneous nerve located at a distance from the brachial plexus at two different times, wherein, ultimately, the brachial plexus is stimulated
  • Heart rhythm measures can be recorded with optical, electrical, and/or accelerometery-based sensors.
  • studies have shown that increased stress levels can increase blood pressure. Activities such as exercise, can also affect cardiac rate and/or rhythm, and/or affect blood pressure - measuring accelerometry (motion), heart rate, etc. could help identify these activities and normalize the measurements by similar activities.
  • hypertension has been correlated with heart failure - measuring ventricle dyssynchrony with ECG sensors could help identify the effectiveness of the stimulation to chronically reduce hypertension.
  • the device can provide stimulation based on measurements of one or more biological measures, a determination of a person’s state, and/or a prediction of cardiac dysrhythmia, cardiac dyssynchrony, and/or a change in blood pressure.
  • the responsiveness could be dependent on activity. For instance in arrhythmias that may be exacerbated with activity, a motion sensor such as an accelerometer or gyroscope could sense if a person is exercising, for example. During that time, the device could turn on to provide appropriate stimulation. In some embodiments, the device could turn off once the activity is complete. In some embodiments, the sensors could activate stimulation during periods of no activity (e.g., when the subject is sleeping).
  • a motion sensor such as an accelerometer or gyroscope could sense if a person is exercising, for example. During that time, the device could turn on to provide appropriate stimulation. In some embodiments, the device could turn off once the activity is complete. In some embodiments, the sensors could activate stimulation during periods of no activity (e.g., when the subject is sleeping).
  • the responsiveness of stimulation could be dependent on one, two, or more sensors housed in the device to collect, store, and analyze biological measures about the wearer including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV), photoplethysmography (PPG), or ventricular and/or atrial dyssynchrony using electrodes to measure ECG and/or heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM).
  • motion e.g., accelerometers, gyroscopes, magnetometer, bend sensors
  • ground reaction force or foot pressure e.g., force sensors or pressure insoles
  • muscle activity e
  • Sympathetic and parasympathetic activity can be measured through several methods, including microneurography (MSNA), catecholamine tests, heart rate, HRV, or galvanic skin response as described elsewhere herein.
  • MSNA microneurography
  • catecholamine tests catecholamine tests
  • heart rate heart rate
  • HRV galvanic skin response as described elsewhere herein.
  • HRV measurements in subjects with cardiovascular disease can be significantly different compared to controls.
  • heartbeat frequencies can be separated into distinct bands.
  • High-frequency signals (between about 0.15 Hz and about 0.4 Hz) can almost exclusively reflect parasympathetic activity, and low- frequency signals (between about 0.04 Hz and about 0.15 Hz) can represent a mixture of sympathetic and parasympathetic activity.
  • taking the ratio of high frequency (HF) to low frequency (LF) signals yields an approximation of one’s sympathetic tone.
  • Very low frequency (VLF) signals (between about 0.004 Hz and about 0.040 Hz) can also be evaluated to assess parasympathetic activity.
  • the total power of HRV in the frequency domain can also be evaluated to assess autonomic activity.
  • Sympathetic and parasympathetic functions can also be evaluated, for example, by analyzing mean normal-to-normal intervals, e.g., all intervals between adjacent QRS complexes of measured cardiac rhythm, including the number of interval differences of successive NN intervals greater than 50 milliseconds; square root of the mean squared differences of successive NN intervals, and standard deviation of the NN intervals.
  • mean normal-to-normal intervals e.g., all intervals between adjacent QRS complexes of measured cardiac rhythm, including the number of interval differences of successive NN intervals greater than 50 milliseconds; square root of the mean squared differences of successive NN intervals, and standard deviation of the NN intervals.
  • sympathetic activity can also be assessed using more traditional techniques, such as measuring blood pressure changes before release and before starting a hand grip exercise, or measuring blood pressure changes before and after immersing the hand in a bath of cold water (e.g., cold pressor test).
  • Parasympathetic activity can be assessed by measuring heart rate response during deep breathing, or heart rate response to standing from lying or seated position (orthostatics), or by changing the orientation of a person’s body using, for example, a tilt table.
  • one, two, or more additional sensors are disposed in the device, including electrical and/or accelerometer sensors in contact with the wearer’ s skin to measure cardiac activity or pressure sensors to measure changes in blood vessels, to be used in combination with an optical sensor to improve the fidelity of heart rate measurement.
  • electrodermal activity also known as galvanic skin response or skin conductance response, for example, can be measured as disclosed elsewhere herein.
  • significant changes in sympathetic and/or parasympathetic activity can be used to predict the onset of a ventricular and/or atrial dyssynchrony or heart rhythm abnormalities, and the device can start stimulation to prevent or reduce the duration of the dyssynchrony event. Adjustments could be made in real-time, or in subsequent stimulation sessions.
  • stimulation frequency can be adjusted to either increase or decrease autonomic activity modulated by a single specific nerve, or multiple nerves.
  • relatively low frequency stimulation of a target nerve can potentially inhibit the nerve and thus decreases sympathetic activity
  • higher frequency stimulation e.g., above a threshold value, e.g., about 5 Hz
  • pulse width of the stimulation waveform can be adjusted to recruit more or less of a specific fiber type, including cutaneous fibers, which can inhibit sympathetic activity. The same effect can occur with the same or other target nerves to regulate parasympathetic activity.
  • systems and methods can include assessment of sympathovagal balance using measurements of heart rate variability, galvanic skin response, and arrhythmias, e.g., atrial fibrillation events to determine likelihood of response to peripheral stimulation.
  • a device could be worn on the wrist that combines sensors to measure heart rate, such as optical based sensors, and/or galvanic skin response to assess the sympathovagal balance and detect arrhythmia, e.g., atrial fibrillation events, and a stimulation device.
  • the device could measure HRV and/or GSR and detects atrial fibrillation events over a specified period of time, such as 1-3 days, or 1 week, to adjust stimulation parameters (e.g., stimulation frequency, alternating frequency, duration of stimulation, stimulation time of day, pulse width, amplitude, duty cycle, phase, waveform shape, waveform symmetry, pulse spacing, on/off time, bursting) based on an assessment of sympathovagal balance and detection of arrhythmic events.
  • stimulation of one, two, or more nerves in the upper and/or lower extremity can be combined with stimulation of the auricular branch of the vagus nerve, such as by way of the tragus, to modulate vagal activity and restore balance of the autonomic nervous system.
  • the number of episodes of symptoms could be detected in various ways to control the stimulation applied by system and devices.
  • the patient can enter events related to cardiac symptoms, including but not limited to chest pain, dyspnea, lightheadedness, and/or palpitations events on a mobile device.
  • the form of the wearable monitor and/or therapy unit could be a wrist band or watch, a ring, a glove, an arm sleeve or arm band or cuff, knee band, sock, leg sleeve or cuff, an ear piece/headphone, head band, a necklace or neck band, or a compliant patch that conforms to multiple locations on the body.
  • specific fiber types within a nerve or nerves can be selectively or preferentially activated (e.g., create action potentials in such specific fiber types) to restore autonomic balance by specifically modulating sympathetic and parasympathetic limbs of the autonomic nervous system (e.g., selectively or preferentially only one, or more than one of A-alpha, A-beta, A-delta, B, and/or C fibers).
  • systems and methods do not stimulate or substantially stimulate A-alpha, A-beta, A-delta, B fibers, or C fibers.
  • Superficial fibers are finer (e.g., smaller diameter) afferents that relay sensory information to the superficial dorsal hom, which is a distinct region of the dorsal horn and spinal gray matter; deep fibers are thicker (e.g., larger diameter) afferents that relay sensory information to the deep dorsal horn.
  • peripheral nerve effectors can be positioned, e.g., on the patient’s skin such as on the medial side of the forearm as to stimulate the median cutaneous nerve but not stimulate or not substantially stimulate the median, radial, or ulnar nerves, or at least stimulate the medial cutaneous nerve preferentially.
  • the lateral cutaneous nerve and/or musculocutaneous nerve, or specific fibers thereof can be preferentially or specifically stimulated.
  • only a single type of nerve fiber is activated, while other types are not activated. For example, in one embodiment, only A-alpha fibers are activated but B fibers are not activated.
  • frequency of a sine wave pattern can be controlled to selectively or preferentially activate specific fiber types. For example, frequencies of about 2000 Hz, about 250 Hz, and about 5 Hz can selectively or preferentially activate A-beta, A- delta and C afferent fibers, respectively.
  • Timing of the stimulation may be simultaneous, or with a delay to account for differences in conduction velocities for the different nerves such that the signals reach the brachial plexus at the same time.
  • simultaneous or near simultaneous activation of the brachial plexus can enhance stimulation through the pathway to the stellate ganglia, and increase the effect (e.g., inhibition) of the sympathetic nervous system.
  • the average conduction velocities of sensory nerves of radial, median, and ulnar nerves are about 51 m/s, 60 m/s, and 63 m/s respectively.
  • a multi-modal methods for treating cardiac arrhythmias or hypertension can include any number of the following: positioning a first peripheral nerve effector on a patient’s skin on an upper extremity of the patient to stimulate a first peripheral nerve selected from the group consisting of one of a median nerve, radial nerve, and ulnar nerve of the patient; positioning a second peripheral nerve effector on a tragus of an ear or auricular vagus (e.g., via the cymba concha) of the patient to stimulate a second peripheral nerve associated with a parasympathetic nervous pathway of the patient; delivering a first nerve stimulation signal to the first peripheral nerve effector to stimulate the first peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension; and delivering a second nerve stimulation signal to the second peripheral nerve effector to stimulate the second peripheral nerve sufficient to modify at least one brain or spinal cord autonomic feedback loop relating to the cardiac arrhythmia or hypertension; and delivering a
  • a first stimulator may comprise a thermal stimulator and a second stimulator may comprise a radiofrequency stimulator.
  • a first stimulator may comprise a thermal stimulator and a second stimulator may comprise a microwave stimulator.
  • a first stimulator may comprise a mechanical stimulator and a second stimulator may comprise a focused ultrasonic stimulator (e.g., focused ultrasound).
  • a first stimulator may comprise a mechanical stimulator and a second stimulator may comprise a radiofrequency stimulator.
  • a first stimulator may comprise a mechanical stimulator and a second stimulator may comprise a microwave stimulator.
  • a first stimulator may comprise a focused ultrasonic stimulator (e.g., focused ultrasound) and a second stimulator may comprise a radiofrequency stimulator.
  • a first stimulator may comprise an ultrasonic (e.g., focused ultrasound) stimulator and a second stimulator may comprise a microwave stimulator.
  • a first stimulator may comprise a radiofrequency stimulator and a second stimulator may comprise a microwave stimulator.
  • Some embodiments can involve stimulation patterns (e.g., bursting, pulse patterns, random, pseudo-random, or noise) selected to improve the efficiency and/or efficacy of stimulation.
  • stimulation patterns e.g., bursting, pulse patterns, random, pseudo-random, or noise
  • an array of electrodes can be aligned along the axon of the nerve and adjacent pairs of electrodes can be stimulated at regular intervals such that specific points along the nerve are stimulated at a velocity of, for example, between about 1 cm/s and about 10 cm/s (e.g., about 1 cm/s, about 2 cm/s, about 3 cm/s, about 4 cm/s, about 5 cm/s, about 6 cm/s, about 7 cm/s, about 8 cm/s, about 9 cm/s, about 10 cm/s, and ranges between such values).
  • stimulation can be provided in a bursting pattern where the bursting can either be rhythmic (e.g., at regular intervals) or pseudorandom.
  • a stimulation waveform can be provided that combines infraslow stimulation frequency (0.01-0.1 Hz) with a higher frequency stimulation (l-200Hz), or lower frequency (l-200Hz) with very high frequencies (lOOO-lOkHz).
  • a processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

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Abstract

L'invention concerne un stimulateur de nerf périphérique destiné à stimuler un nerf périphérique de façon à traiter un tremblement essentiel et d'autres troubles du mouvement, ainsi qu'une vessie hyperactive, un dysfonctionnement cardiaque et un dysfonctionnement de neurotransmetteurs. Le stimulateur de nerf périphérique peut être un stimulateur de surface non invasif destiné à assurer une thérapie multimodale optimisée. La stimulation peut être vibratoire, électromécanique, thermique, rayonnante, électrique, magnétique, électromagnétique, lumineuse, mécanique, chimique, thermique, ultrasonore, à radiofréquence (RF), acoustique, infrarouge, ultraviolette, à rayons X et/ou à micro-ondes. La stimulation peut être délivrée en utilisant un système à boucle ouverte et/ou un système à boucle fermée avec rétroaction. La stimulation peut être effectuée sur un ou plusieurs sites.
PCT/US2019/039193 2018-06-27 2019-06-26 Stimulation multimodale de traitement des tremblements Ceased WO2020006048A1 (fr)

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CN201980055793.8A CN112601488A (zh) 2018-06-27 2019-06-26 用于治疗震颤的多模态刺激
EP19825339.5A EP3813647A4 (fr) 2018-06-27 2019-06-26 Stimulation multimodale de traitement des tremblements

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