IP Library Granted Patent US 9,522,272
Granted Patent B2
US 9,522,272 · App. 14/252,727 · Granted Dec 20, 2016

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

Inventors: Michael P. Kilgard (Richardson, TX); Nazer Engineer (Plano, TX); David Michael Pierce (Plano, TX); Robert L. Rennaker (Sachse, TX)
Assignee: THE BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM
A61N1/36139A61N1/36003A61N1/36053A61N1/36067A61N1/36092A61N1/36103A61N1/36178A61N1/37217A61N1/37235A61N1/37247G09B23/28A61B5/1124A61N1/361A61N1/36132
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Quick Facts
Patent No.
US 9,522,272
App. No.
14/252,727
Granted
Dec 20, 2016
Kind
B2
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.

Claims (57)

1. A method of improving motor deficits in a stroke patient, comprising:

assessing a stroke patient's motor deficits;

determining therapeutic goals for the patient, based on the patient's motor deficits;

selecting one or more therapeutic tasks based on the therapeutic goals;

observing repetitive performances by the patient of the selected therapeutic task;

stimulating the vagus nerve of the patient with an implanted neurostimulator that delivers pulse trains of electrical stimulation energy to a vagus nerve while the patient is performing a movement of the selected therapeutic task;

terminating the stimulation of the vagus nerve so that there is no stimulation between movement execution; and

improving the patient's motor deficits,

wherein the pulse trains are delivered for a period of time during the movement, and the period of time has a duration that is different than a duration of the movement.

2. The method of claim 1 , wherein the pulse trains are about 500 milliseconds in duration.

3. The method of claim 1 , wherein the pulse trains have an amplitude of about 0.8 milliamperes.

4. The method of claim 1 , wherein the pulse trains are no longer than about 500 milliseconds in duration.

5. The method of claim 1 , further comprising operating the implanted neurostimulator to deliver pulse trains of electrical stimulation energy to the vagus nerve such that a pulse train results in respective directed neuro plasticity lasting no more than about 8 seconds.

6. The method of claim 1 , wherein the pulse trains have a current of no more than about 0.8 milliamperes.

7. The method of claim 1 , wherein the pulse trains have a current of no less than about 0.8 milliamperes.

8. The method of claim 1 , wherein the action of stimulating the vagus nerve of the patient further comprises automatically sensing respective performances of the selected therapeutic task, and applying the pulse trains to the vagus nerve based on the sensed beginnings of the performances.

9. The method of claim 1 , wherein the vagus nerve stimulation pulse train is not presented between performances of the selected skilled motor task.

10. The method of claim 1 , further comprising operating the implanted neurostimulator to deliver pulse trains of electrical stimulation energy to the vagus nerve such that respective pulse trains of the delivered pulse trains results in respective directed neuro plasticity lasting no more than about 8 seconds.

11. A method of improving motor deficits in a stroke patient, comprising:

assessing a stroke patient's motor deficits; determining therapeutic goals for the patient, based on the patient's motor deficits; selecting a therapeutic task based on the therapeutic goals;

detecting motion during repetitive performances by the patient of the selected therapeutic task;

automatically stimulating a vagus nerve of the patient with an implanted neurostimulator that delivers pulse trains of electrical stimulation energy to the vagus nerve when a predetermined motion is detected;

ending the stimulation of the vagus nerve so that there is no stimulation between the repetitive performances; and

improving the patient's motor deficits,

wherein the pulse trains are delivered for a period of time during the predetermined motion, and the period of time has a duration that is different than a duration of the predetermined motion.

12. The method of claim 11 , wherein the pulse trains are about 500 milliseconds in duration.

13. The method of claim 11 , wherein the pulse trains have an amplitude of about 0.8 milliamperes.

14. The method of claim 11 , wherein the motion is detected by detecting change in color of an object by a camera, wherein the object is supported by the patient.

15. The method of claim 11 , wherein the action of automatically stimulating the vagus nerve of the patient is executed such that a pulse train results in respective directed neuro plasticity lasting no more than about 8 seconds.

16. The method of claim 11 , wherein the action of automatically stimulating the vagus nerve of the patient is executed such that respective pulse trains of the delivered pulse trains results in respective directed neuro plasticity lasting no more than about 8 seconds.

17. A system for providing therapy for a motor deficit, comprising:

an implantable stimulation system comprising an implantable pulse generator, an electrode and a lead coupling the implantable pulse generator to the electrodes, wherein the implantable stimulation system stimulates a patient's vagus nerve with at least one pulse train having a duration of about 500 milliseconds;

a clinical controller comprising a processor, stimulation control software, manual interfaces and a display;

an external communication device configured to communicate between the clinical controller and the implantable stimulation system; and

a manual input device configured to communicate with the clinical controller,

wherein the manual input device is configured to be engaged during performance of a therapeutic task causing the clinical controller to send a signal through the external communication device to the implantable stimulation system, so that the patient's vagus nerve is stimulated during the performance of the therapeutic task.

18. The system of claim 17 , further comprising a hand held control magnet configured to communicate with the implantable stimulation system.

19. The system of claim 17 , wherein the implantable stimulation system is configured to stimulate the patient's vagus nerve with a pulse train that is about 0.8 milliamperes.

20. A system for providing automated therapy for a motor deficit, comprising:

an implantable stimulation system comprising an implantable pulse generator, an electrode and a lead coupling the implantable pulse generator to the electrode, wherein the implantable stimulation system stimulates a patient's vagus nerve;

a clinical controller comprising a processor, stimulation control software, manual interfaces and a display;

an external communication device configured to communicate between the clinical controller and the implantable stimulation system;

a task object, configured to be used in performance of a therapeutic task;

a colored marker, configured to attach to the task object and having a predetermined color; and

a motion detector, configured to be coupled to the clinical controller;

wherein using data generated by the motion detector, the clinical controller is configured to identify a starting location of the colored marker, detects motion of the colored marker associated with performance of the therapeutic task and generates communication with the implantable stimulation system so that the patient's vagus nerve is stimulated during the performance of the therapeutic task by at least one pulse train having a duration less than a duration of the therapeutic task.

21. The system of claim 20 wherein the motion detector is a digital camera.

22. The system of claim 20 , wherein the clinical controller is configured to calculate displacement of the object to trigger stimulation.

23. The system of claim 20 wherein the clinical controller is configured to calculate speed of motion to trigger stimulation.

24. The system of claim 20 , further comprising a manual interrupt configured to couple to the clinical controller, wherein the manual interrupt prevents stimulation when engaged.

25. The system of claim 20 , further comprising a manual interrupt configured to couple to the clinical controller, wherein the manual interrupt allows stimulation when released.

26. The system of claim 20 wherein the clinical controller is configured to calculate change in height of the object to trigger stimulation.

27. The system of claim 20 wherein the clinical controller is configured to calculate rotation of the object to trigger stimulation.

28. The system of claim 20 , wherein the clinical controller is configured to calculate acceleration of motion to trigger stimulation.

29. The system of claim 20 , wherein the motion detector is configured to detect changes in color of the object by a camera.

30. The system of claim 20 , wherein the implantable stimulation system is configured to stimulate the patient's vagus nerve with a pulse train that is about 500 milliseconds in duration.

31. The system of claim 20 , wherein the implantable stimulation system is configured to stimulate the patient's vagus nerve with a pulse train that is about 0.8 milliamperes.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2021
From: ENGINEER, NAVZER D.; PIERCE, DAVID M.
To: BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM
Reel/Frame 057209/0629 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 2, 2016
From: MICROTRANSPONDER INC.
To: THE BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM
Reel/Frame 039315/0967 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2014
From: KILGARD, MICHAEL P.; ENGINEER, NAVZER; PIERCE, DAVID; RENNEKAR, ROB
To: MICROTRANSPONDER, INC.; THE BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM
Reel/Frame 032671/0790 →
Continuity (14)
Continuation 13651349 · Oct 12, 2012
Continuation In Part 13095570 · Apr 27, 2011
Continuation In Part 12485040 · Jun 15, 2009
Provisional Application 61699470 · Sep 11, 2012
Provisional Application 61614369 · Mar 22, 2012
Provisional Application 61598185 · Feb 13, 2012
Provisional Application 61558287 · Nov 10, 2011
Provisional Application 61627532 · Oct 13, 2011
Provisional Application 61328621 · Apr 27, 2010
Provisional Application 61077648 · Jul 2, 2008
Provisional Application 61078954 · Jul 8, 2008
Provisional Application 61086116 · Aug 4, 2008
Provisional Application 61149387 · Feb 3, 2009
Related Publication 20140228908A1 · Aug 14, 2014