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

• US 9,522,272 B2
• Filed: 04/14/2014
• Issued: 12/20/2016
• Est. Priority Date: 07/02/2008
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Kilgard, Michael P., Engineer, Nazer, Pierce, David Michael, Rennaker, Robert L.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/252,727
• Publication Number:
  US 20140228908A1
• Time in Patent Office: 981 Days
• Field of Search: 607/2, 607/3, 607/116, 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1124 Determining motor skills
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36092 Mental training
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: 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
• CPC Class Codes: G09B 23/28 for medicine

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

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.