# US 2025/0082936 A1 · Methods, systems, and devices for pairing vagus nerve stimulation with motor therapy in patient who has hemiparesis

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- Number: US 2025/0082936 A1
- Document ID: US20250082936A1
- Status: Published application
- Kind: A1
- Application number: 18/959,959
- Filed: 2024-11-26
- Published: 2025-03-13
- Earliest claimed: 2023-05-02
- Assignees: Board of Regents, The University of Texas System
- Applicants: Board of Regents, The University of Texas System
- Inventors: Michael P. KILGARD; Navzer ENGINEER; David Michael PIERCE; Robert L. RENNAKER
- Web page: https://patentgrep.com/patent/US20250082936A1

## CPC

- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/36092: {Mental training}
- A61N 1/361: {Phantom sensations, e.g. tinnitus}
- A61N 1/36103: {Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile}
- A61N 1/37235: {Aspects of the external programmer}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- G09B 23/28: for medicine
- A61B 5/1124: {Determining motor skills}
- A61N 1/36132: {using patient feedback}
- A61N 2007/0026: {Stimulation of nerve tissue}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A motor-deficit-therapeutic method (for treatment of a patient who has hemiparesis) includes: providing, to the patient afflicted with hemiparesis, a neurostimulator configured to stimulate a vagus nerve of the patient using electrical stimulation; and initiating stimulation of the vagus nerve so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator.

## Claims

### Claim 1

A motor-deficit-therapeutic method for treatment of a patient who has hemiparesis, the method comprising:
providing, to the patient afflicted with hemiparesis, a neurostimulator configured to stimulate a vagus nerve of the patient using electrical stimulation; and
initiating stimulation of the vagus nerve so that at least a portion of the stimulation occurs in temporal proximity to performance by the patient of a motor therapy session which is hemiparesis-therapeutic, thereby improving the patient's hemiparesis, the stimulation being provided by the neurostimulator.

### Claim 2 (depends on 1)

The method of claim 1, wherein:
the initiating stimulation so that at least a portion of the stimulation occurs at least during performance by the patient of a motor therapy session which is hemiparesis-therapeutic.

### Claim 3 (depends on 1)

The method of claim 1, wherein the initiating stimulation includes:
controlling the neurostimulator to provide a series of electrical pulse trains; or
controlling the neurostimulator to provide a programmed sequence of electrical pulse trains.

### Claim 4 (depends on 1)

The method of claim 1, wherein the initiating stimulation includes:
controlling the neurostimulator to provide an electrical pulse train in response to a received signal.

### Claim 5 (depends on 1)

The method of claim 1, wherein:
the motor therapy session includes one or more tasks;
during the motor therapy session, at least one of the one or more tasks undergoes one or more repetitions;
at least one of the one or more tasks includes one or more associated voluntary muscle movements; and
two or more sessions comprise a treatment plan.

### Claim 6 (depends on 5)

The method of claim 5, wherein:
a timing of the stimulation is based on completion of one of the one or more repetitions.

### Claim 7 (depends on 5)

The method of claim 5, wherein:
for at least one of the one or more tasks which undergoes one or more repetitions, there are substantially no task-associated voluntary muscle movements during an interval between a given one of the associated one or more voluntary muscle movements and a subsequent one of the associated one or more voluntary muscle movements, the interval having a duration, T, which is greater than zero, T>0.

### Claim 8 (depends on 5)

The method of claim 5, wherein:
the motor therapy session is motor-deficit-therapeutic; and
performance by the patient of the one or more associated voluntary muscle movements includes one or more of:
moving one or more extremities of the patient based on the associated task;
reaching at least one hand of the patient towards a targeted object;
touching a targeted object;
grasping the targeted object with at least one hand of the patient; or
moving the targeted object while the targeted object is being grasped with at least one hand of the patient.

### Claim 9 (depends on 5)

The method of claim 5, wherein:
each session includes about 3 to about 5 tasks;
in each session, each of the tasks undergoes about 30 to about 75 repetitions; and
a duration of each session is in a range of about 30 minutes to about 120 minutes.

### Claim 10 (depends on 5)

The method of claim 5, wherein:
for at least one of the one or more tasks, performance by the patient of the one or more associated voluntary muscle movements includes:
a planning stage which precedes one of the one or more associated voluntary muscle movements.

### Claim 11 (depends on 1)

The method of claim 1, wherein:
the stimulation of the vagus nerve does not directly stimulate motor cortex neurons.

### Claim 12 (depends on 1)

The method of claim 1, wherein:
the stimulation of the vagus nerve triggers a release of neuromodulators in motor cortex of the patient during performance by the patient of the motor therapy session.

### Claim 13 (depends on 12)

The method of claim 12, wherein:
neuromodulators in the release of neuromodulators in motor cortex of the patient include acetylcholine and norepinephrine.

### Claim 14 (depends on 1)

The method of claim 1, wherein:
current comprising the electrical stimulation of the patient's vagus nerve has an amplitude of no less than about 0.8 milliamperes.

### Claim 15 (depends on 1)

The method of claim 1, wherein:
the hemiparesis is improved by improving a motor function of the patient.

### Claim 16 (depends on 1)

The method of claim 1, wherein:
the hemiparesis is improved by lessening a motor deficit of the patient.

### Claim 17 (depends on 1)

The method of claim 1, wherein:
a timing of the stimulation is based on a successful aspect of one or more voluntary muscle movements by the patient.

### Claim 18

A method for treatment of a patient who has hemiparesis, the method comprising:
for each of one or more tasks that are intended to be performed, instructing the patient to perform the task at least once, the task including one or more associated voluntary muscle movements, and the task being rehabilitative for hemiparesis; and
in temporal proximity to at least one of the one or more tasks,
stimulating a vagus nerve of the patient using electrical stimulation thereby improving the patient's hemiparesis.

### Claim 19 (depends on 18)

The method of claim 18, wherein:
the stimulating a vagus nerve occurs during at least partial overlap of at least one of the one or more tasks.

### Claim 20 (depends on 18)

The method of claim 18, wherein:
the stimulating of the vagus nerve resulting in raised levels of neuromodulators in motor cortex of the patient, the raised levels of the neuromodulators creating an opportunity of enhanced hemiparesis rehabilitation for a period (opportunity period); and
the at least partial overlap pairs the at least one of the one or more tasks and the opportunity period thereby improving the patient's hemiparesis.

### Claim 21 (depends on 20)

The method of claim 20, wherein:
the neuromodulators include acetylcholine and norepinephrine.

### Claim 22 (depends on 18)

The method of claim 18, wherein:
the vagus nerve is a driver of an ascending neuromodulatory system.

### Claim 23 (depends on 18)

The method of claim 18, wherein:
the stimulating of the vagus nerve does not directly stimulate motor cortex neurons.

### Claim 24 (depends on 18)

The method of claim 18, wherein, for at least one of the one or more tasks, performance by the patient of the one or more associated voluntary muscle movements includes one or more of:
moving one or more extremities of the patient based on a current task to be performed;
reaching at least one hand of the patient towards a targeted object;
touching a targeted object;
grasping the targeted object with at least one hand of the patient; or
moving the targeted object while the targeted object is being grasped with at least one hand of the patient.

### Claim 25 (depends on 18)

The method of claim 18, wherein:
performance at least once of each the one or more tasks comprises a session; and
two or more sessions comprise a treatment plan (TP).

### Claim 26 (depends on 25)

The method of claim 25, wherein:
during the session, at least one of the one or more tasks undergoes one or more repetitions;
at least one task includes one or more associated voluntary muscle movements; and
a timing of the stimulation is based on completion of one of the one or more repetitions.

### Claim 27 (depends on 25)

The method of claim 25, wherein:
each session includes about 3 to about 5 tasks;
in each session, each of the tasks undergoes about 30 to about 75 repetitions; and
a duration of each session is in a range of about 30 minutes to about 120 minutes.

### Claim 28 (depends on 18)

The method of claim 18, wherein:
for at least one of the one or more tasks, there are substantially no task-associated voluntary muscle movements during an interval between a given one of the one or more associated voluntary muscle movements that comprise the task and a subsequent one of the one or more associated voluntary muscle movements that comprise the task, the interval having a duration, T, which is greater than zero, T>0.

### Claim 29 (depends on 18)

The method of claim 18, wherein:
at least one of the one or more tasks includes a planning stage which precedes one of the one or more associated voluntary muscle movements.

### Claim 30 (depends on 18)

The method of claim 18, wherein improvement in the patient's hemiparesis is assessed according to one or more as follows including:
regarding results of visual inspections (visual inspection results) of the patient's hemiparesis, comparing visual inspection results made before the treatment and made after at least some portion of the treatment had begun;
regarding answers by the patient to a questionnaire, comparing ones of the answers made before the treatment and ones of the answers made after at least some portion of the treatment had begun;
regarding noninvasive mapping of motor cortex representations of a given one of the one or more tasks, comparing mappings made before the treatment and made after at least some portion of the treatment had begun;
regarding objective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the objective ratings made before the treatment and ones of the objective ratings made after at least some portion of the treatment had begun; or
regarding subjective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the subjective ratings made before the treatment and ones of the subjective ratings made after at least some portion of the treatment had begun.

### Claim 31 (depends on 18)

The method of claim 18, wherein:
current comprising the electrical stimulation of the patient's vagus nerve has an amplitude of no less than about 0.8 milliamperes.

### Claim 32 (depends on 18)

The method of claim 18, wherein:
the hemiparesis is improved by improving a motor function of the patient.

### Claim 33 (depends on 18)

The method of claim 18, wherein:
the hemiparesis is improved by lessening a motor deficit of the patient.

### Claim 34 (depends on 18)

The method of claim 18, wherein:
a timing of the stimulation is based on a successful aspect of one or more voluntary muscle movements by the patient.

### Claim 35

A motor-deficit-therapeutic method for treatment of a patient who has hemiparesis, the method comprising:
for each of one or more tasks that are intended to be performed, instructing the patient to perform at least one repetition of the task, the task including one or more associated voluntary muscle movements, and the task being rehabilitative for hemiparesis; and
in temporal proximity to at least one of the one or more tasks,
stimulating a vagus nerve of the patient using electrical stimulation which creates an opportunity of motor cortex plasticity in a brain of the patient for an opportunity period; and
wherein the temporal proximity pairs the at least one of the one or more tasks and the opportunity period thereby improving the patient's hemiparesis.

### Claim 36 (depends on 35)

The method of claim 35, wherein:
the stimulating a vagus nerve occurs during at least partial overlap of at least one of the one or more tasks.

### Claim 37 (depends on 35)

The method of claim 35, wherein:
the stimulating of the vagus nerve resulting in raised levels of neuromodulators in motor cortex of the patient, the raised levels of the neuromodulators improving the opportunity of motor plasticity thereby improving the patient's hemiparesis.

### Claim 38 (depends on 37)

The method of claim 37, wherein:
the neuromodulators include acetylcholine and norepinephrine.

### Claim 39 (depends on 35)

The method of claim 35, wherein:
the vagus nerve is a driver of an ascending neuromodulatory system.

### Claim 40 (depends on 35)

The method of claim 35, wherein:
the stimulating of the vagus nerve does not directly stimulate motor cortex neurons.

### Claim 41 (depends on 35)

The method of claim 35, wherein, for at least one of the one or more tasks, performance by the patient of the one or more associated voluntary muscle movements includes one or more of:
moving one or more extremities of the patient based on a current task to be performed;
reaching at least one hand of the patient towards a targeted object;
touching a targeted object;
grasping the targeted object with at least one hand of the patient; or
moving the targeted object while the targeted object is being grasped with at least one hand of the patient.

### Claim 42 (depends on 35)

The method of claim 35, wherein:
performance at least one once of each of the one or more tasks comprises a session; and
two or more sessions comprise a treatment plan (TP).

### Claim 43 (depends on 42)

The method of claim 42, wherein:
during the session, at least one of the one or more tasks undergoes one or more repetitions;
at least one task includes one or more associated voluntary muscle movements; and
a timing of the stimulation is based on completion of one of the one or more repetitions.

### Claim 44 (depends on 42)

The method of claim 42, wherein:
each session includes about 3 to about 5 tasks;
in each session, each of the tasks undergoes about 30 to about 75 repetitions; and
a duration of each session is in a range of about 30 minutes to about 120 minutes.

### Claim 45 (depends on 35)

The method of claim 35, wherein:
for at least one of the one or more tasks, there are substantially no task-associated voluntary muscle movements during an interval between a given one of the one or more associated voluntary muscle movements that comprise the task and a subsequent one of the one or more associated voluntary muscle movements that comprise the task, the interval having a duration, T, which is greater than zero, T>0.

### Claim 46 (depends on 35)

The method of claim 35, wherein:
at least one of the one or more tasks includes a planning stage which precedes one of the one or more associated voluntary muscle movements.

### Claim 47 (depends on 35)

The method of claim 35, wherein improvement in the patient's hemiparesis is assessed according to one or more as follows including:
regarding results of visual inspections (visual inspection results) of the patient's hemiparesis, comparing visual inspection results made before the treatment and made after at least some portion of the treatment had begun;
regarding answers by the patient to a questionnaire, comparing ones of the answers made before the treatment and ones of the answers made after at least some portion of the treatment had begun;
regarding noninvasive mapping of motor cortex representations of a given one of the one or more tasks, comparing mappings made before the treatment and made after at least some portion of the treatment had begun;
regarding objective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the objective ratings made before the treatment and ones of the objective ratings made after at least some portion of the treatment had begun; or
regarding subjective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the subjective ratings made before the treatment and ones of the subjective ratings made after at least some portion of the treatment had begun.

### Claim 48 (depends on 35)

The method of claim 35, wherein:
current comprising the electrical stimulation of the patient's nerve has an amplitude of no less than about 0.8 milliamperes.

### Claim 49 (depends on 35)

The method of claim 35, wherein:
the hemiparesis is improved by improving a motor function of the patient.

### Claim 50 (depends on 35)

The method of claim 35, wherein:
the hemiparesis is improved by lessening a motor deficit of the patient.

### Claim 51 (depends on 35)

The method of claim 35, wherein:
a timing of the stimulation is based on a successful aspect of one or more voluntary muscle movements by the patient.

### Claim 52

A therapeutic method for treatment of a patient who has hemiparesis but who does not have a movement disorder disease, the method comprising:
for one or more tasks that are intended to be performed, instructing the patient to perform at least one repetition of each task, each task including one or more associated voluntary muscle movements, and each task being rehabilitative for hemiparesis; and
in temporal proximity to at least one of the one or more tasks,
stimulating a vagus nerve of the patient using electrical stimulation thereby improving the patient's hemiparesis.

### Claim 53 (depends on 52)

The method of claim 52, wherein:
the stimulating a vagus nerve occurs during at least partial overlap of at least one of the one or more tasks.

### Claim 54 (depends on 52)

The method of claim 52, wherein:
the stimulating a vagus nerve resuls in raised levels of neuromodulators in motor cortex of the patient, the raised levels of the neuromodulators creating an opportunity of enhanced motor-deficit rehabilitation for a period (opportunity period); and
the at least partial overlap pairs the at least one of the one or more associated voluntary muscle movements and the opportunity period thereby improving the patient's hemiparesis.

### Claim 55 (depends on 54)

The method of claim 54, wherein:
the neuromodulators include acetylcholine and norepinephrine.

### Claim 56 (depends on 52)

The method of claim 52, wherein:
the vagus nerve is a driver of an ascending neuromodulatory system.

### Claim 57 (depends on 52)

The method of claim 52, wherein:
the stimulating of the vagus nerve does not directly stimulate motor cortex neurons.

### Claim 58 (depends on 52)

The method of claim 52, wherein, for at least one of the one or more tasks, performance by the patient of the one or more associated voluntary muscle movements includes one or more of:
moving one or more extremities of the patient based on a current task to be performed;
reaching at least one hand of the patient towards a targeted object;
touching a targeted object;
grasping the targeted object with at least one hand of the patient; or
moving the targeted object while the targeted object is being grasped with at least one hand of the patient.

### Claim 59 (depends on 52)

The method of claim 52, wherein:
performance at least once of each the one or more tasks comprises a session; and
two or more sessions comprise a treatment plan (TP).

### Claim 60 (depends on 59)

The method of claim 59, wherein:
during the session, at least one of the one or more tasks undergoes one or more repetitions;
at least one task includes one or more associated voluntary muscle movements; and
a timing of the stimulation is based on completion of one of the one or more repetitions.

### Claim 61 (depends on 59)

The method of claim 59, wherein:
each session includes about 3 to about 5 tasks;
in each session, each of the tasks undergoes about 30 to about 75 repetitions; and
a duration of each session is in a range of about 30 minutes to about 120 minutes.

### Claim 62 (depends on 52)

The method of claim 52, wherein:
for at least one of the one or more tasks, there are substantially no task-associated voluntary muscle movements during an interval between a given one of the one or more associated voluntary muscle movements that comprise the task and a subsequent one of the one or more associated voluntary muscle movements that comprise the task, the interval having a duration, T, which is greater than zero, T>0.

### Claim 63 (depends on 52)

The method of claim 52, wherein:
at least one of the one or more tasks includes a planning stage which precedes one of the one or more associated voluntary muscle movements.

### Claim 64 (depends on 52)

The method of claim 52, wherein improvement in the patient's hemiparesis is assessed according to one or more as follows including:
regarding results of visual inspections (visual inspection results) of the patient's hemiparesis, comparing visual inspection results made before the treatment and made after at least some portion of the treatment had begun;
regarding answers by the patient to a questionnaire, comparing ones of the answers made before the treatment and ones of the answers made after at least some portion of the treatment had begun;
regarding noninvasive mapping of motor cortex representations of given one of the one or more tasks, comparing mappings made before the treatment and made after at least some portion of the treatment had begun;
regarding objective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the objective ratings made before the treatment and ones of the objective ratings made after at least some portion of the treatment had begun; or
regarding subjective ratings of the patient's performance of a given one of the one or more tasks, comparing ones of the subjective ratings made before the treatment and ones of the subjective ratings made after at least some portion of the treatment had begun.

### Claim 65 (depends on 52)

The method of claim 52, wherein:
current comprising the electrical stimulation of the patient's vagus nerve has an amplitude of no less than about 0.8 milliamperes.

### Claim 66 (depends on 52)

The method of claim 52, wherein:
the hemiparesis is improved by improving a motor function of the patient.

### Claim 67 (depends on 52)

The method of claim 52, wherein:
the hemiparesis is improved by lessening a motor deficit of the patient.

### Claim 68 (depends on 52)

The method of claim 52, wherein:
a timing of the stimulation is based on a successful aspect of one or more voluntary muscle movements by the patient.