Methods, systems, and devices for pairing vagus nerve stimulation with motor therapy in stroke patients

Patent metadata

Field	Value
Publication number	US-11638824-B2
Application number	US-201615382970-A
Country	US
Kind code	B2
Filing date	Dec 19, 2016
Priority date	Jul 2, 2008
Publication date	May 2, 2023
Grant date	May 2, 2023

Abstract

A method of treating motor deficits in a stroke patient, comprising assessing a patient's motor deficits, determining therapeutic goals for the patient, based on the patient's motor deficits, selecting therapeutic tasks based on the therapeutic goals, performing each of the selected therapeutic tasks repetitively, observing the performance of the therapeutic tasks, initiating the stimulation of the vagus nerve manually at approximately a predetermined moment during the performance of the therapeutic tasks, stimulating the vagus nerve of the patient during the performance of the selected therapeutic tasks, and improving the patient's motor deficits.

First claim

What is claimed is:

1. A motor-deficit-therapeutic method for treatment of a patient who has stroke-induced hemiparesis, the method comprising:
providing, to the patient afflicted with a stroke-induced hemiparesis, a neurostimulator configured to stimulate a vagus nerve of the patient using electrical, magnetic, acoustic or mechanical stimulation; and
initiating stimulation of the vagus nerve by the neurostimulator so that at least a portion of the stimulation occurs at least during performance by the patient of a motor therapy session which is stroke-induced hemiparesis-therapeutic, thereby improving the patient's stroke-induced hemiparesis.

2. The method of claim 1 , wherein:
the neurostimulator is further configured to provide a series of electrical pulse trains; or
the neurostimulator is further configured to provide a programmed sequence of electrical pulse trains.

3. The method of claim 1 , wherein:
the neurostimulator is further configured to provide an electrical pulse train in response to a received signal.

4. 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 task includes one or more associated voluntary muscle movements; and
two or more sessions comprise a treatment plan.

5. The method of claim 4 , 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.

6. The method of claim 4 , wherein:
the motor therapy session is stroke-motor-deficit-therapeutic; and
performance by the patient of the one or more 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.

7. The method of claim 4 , 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.

8. The method of claim 4 , 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 a corresponding one of the one or more associated voluntary muscle movements.

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

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

11. The method of claim 10 , wherein:
neuromodulators in the corresponding release of neuromodulators in motor cortex of the patient include acetylcholine and norepinephrine.

12. 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.

13. A method for treatment of a patient who has stroke-induced hemiparesis, the method comprising:
for each of one or more tasks that are intended to be performed, instructing the patient to perform the corresponding task at least once, the corresponding task including one or more associated voluntary muscle movements, and the corresponding task being rehabilitative for stroke-induced hemiparesis; and
during at least partial overlap of at least one of the one or more tasks,
stimulating a vagus nerve of the patient using electrical, magnetic, acoustic or mechanical stimulation thereby improving the patient's stroke-induced hemiparesis.

14. The method of claim 13 , wherein:
the stimulating of the vagus nerve resulting in raised levels of corresponding neuromodulators in motor cortex of the patient, the raised levels of the corresponding neuromodulators creating an opportunity of enhanced stroke-induced hemiparesis rehabilitation for a corresponding 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 stroke-induced hemiparesis.

15. The method of claim 14 , wherein:
the neuromodulators include acetylcholine and norepinephrine.

16. The method of claim 13 , wherein:
the vagus nerve is a driver of an ascending neuromodulatory system.

17. The method of claim 13 , wherein:
the stimulating of the vagus nerve does not directly stimulate motor cortex neurons.

18. The method of claim 13 , 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.

19. The method of claim 13 , 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).

20. The method of claim 19 , 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.

21. The method of claim 13 , 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 corresponding task and a subsequent one of the one or more associated voluntary muscle movements that comprise the corresponding task, the interval having a duration, T, which is greater than zero, T>0.

22. The method of claim 13 , wherein:
at least one of the one or more tasks includes a planning stage which precedes a corresponding one of the one or more associated voluntary muscle movements.

23. The method of claim 13 , wherein improvement in the patient's stroke-induced hemiparesis is assessed according to one or more of the following:
regarding results of visual inspections (visual inspection results) of the patient's stroke-induced 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 corresponding questionnaire, comparing answers made before the treatment and 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 a

Assignees

• Univ Texas

Inventors

• Kilgard Michael P
• Engineer Nazer
• Pierce David Michael
• Rennaker Robert L

Classifications

• A61N2007/0026

  Stimulation of nerve tissue · CPC title

• A61B5/1124

  Determining motor skills · CPC title

• A61N1/36003

  of motor muscles, e.g. for walking assistance · CPC title

• A61N1/36103

  Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke · CPC title

• A61N1/36092

  Mental training · CPC title