Treatment of phantom limb pain and diabetic neuropathy pain, and increasing prosthetic control, by stimulation of dorsal rootlets and lateral spinal cord

Patent metadata

Field	Value
Publication number	US-11433238-B2
Application number	US-202016845691-A
Country	US
Kind code	B2
Filing date	Apr 10, 2020
Priority date	Apr 10, 2019
Publication date	Sep 6, 2022
Grant date	Sep 6, 2022

Abstract

The present disclosure provides a method of reducing phantom limb pain or diabetic neuropathy pain, and increasing prosthetic control, by stimulating dorsal spinal rootlets and/or lateral spinal cord adjacent to the dorsal rootlets, of sensory neurons innervating the limb with the phantom limb pain or diabetic neuropathy pain, or the prosthetic.

First claim

It is claimed:

1. A method for reducing phantom limb pain or diabetic neuropathy pain in a subject, comprising:
providing a therapeutically effective amount of stimulation to dorsal rootlets, or lateral spinal cord adjacent to the dorsal rootlets, of one or more sensory neurons innervating a limb of the subject with the phantom limb pain or the diabetic neuropathy pain; and wherein:
the stimulation is provided with one or more electrodes of a neurostimulator that are implanted at the dorsal rootlets or the lateral spinal cord adjacent to the dorsal rootlets of the one or more sensory neurons innervating the limb of the subject;
the one or more electrodes are activated to provide the stimulation in response to activation of a sensor detecting movement and/or position of the limb or movement and/or position of a physical or virtual prosthesis of the limb; and
the stimulation reduces the phantom limb pain or diabetic neuropathy pain in the subject.

2. The method of claim 1 , further comprising calibrating the stimulation to induce sensations of pressure, touch, movement, proprioception, and/or kinesthesia at the location of the phantom limb pain or diabetic neuropathy pain in the subject.

3. The method of claim 1 , wherein stimulating the dorsal rootlets or the lateral spinal cord does not cause paresthesia in the limb with the phantom limb pain or diabetic neuropathy pain.

4. The method of claim 1 , wherein the neurostimulator is an external or implanted pulse generator.

5. The method of claim 1 , further comprising implanting the neurostimulator in the subject.

6. The method of claim 1 , wherein the sensor is any one of a gyroscope, an electrogoniometer, a textile piezoresistive sensor, or a pressure sensor located in or on the limb or the prosthesis of the subject.

7. The method of claim 1 , wherein the sensor detects pressure at the fingertips of a prosthetic hand or in the sole of a prosthetic foot.

8. The method of claim 1 , wherein the sensor detects a position of the limb or the physical or virtual prosthesis of the limb.

9. The method of claim 1 , wherein the virtual prosthesis of the limb is a computer-generated image of the limb the movement of which is observed or controlled by the subject.

10. The method of claim 1 , further comprising selecting the subject with the phantom limb pain or diabetic neuropathy pain for treatment.

11. The method of claim 1 , wherein providing the therapeutically effective amount of stimulation comprises applying electrical stimulation at a frequency of from 1-300 Hz, an amplitude of from 0.1-10 mA, and a pulse duration of from 50-500 μsec, to the dorsal rootlets or the lateral spinal cord adjacent to the dorsal rootlets innervating the limb of the subject.

12. The method of claim 1 , wherein the neurostimulator is implanted at the dorsal rootlets of the sensory neurons innervating the limb of the subject.

13. The method of claim 1 , wherein the neurostimulator is implanted at the lateral spinal cord adjacent to the dorsal rootlets of the sensory neurons innervating the limb of the subject.

14. The method of claim 1 , wherein treating the phantom limb pain or diabetic neuropathy pain comprises at least a 50% decrease in pain as measured using the McGill pain score.

15. A method for increasing control of a prosthetic limb of a subject, comprising:
providing a therapeutically effective amount of stimulation to dorsal rootlets, or lateral spinal cord adjacent to the dorsal rootlets, of sensory neurons innervating an amputated limb of the subject, wherein the subject uses a prosthesis of the amputated limb; and wherein:
the stimulation is provided with one or more electrodes of a neurostimulator that are implanted at the dorsal rootlets or the lateral spinal cord adjacent to the dorsal rootlets of the sensory neurons innervating the amputated limb;
the one or more electrodes are activated to provide the stimulation in response to activation of a sensor detecting movement and/or position of a stump of the limb or the prosthesis or in response to movement and/or position of a virtual prosthesis of the limb; and
the stimulation improves control of the prosthesis of the limb by the subject.

16. The method of claim 15 , further comprising calibrating the stimulation to induce sensations of pressure or touch in the amputated limb.

17. The method of claim 15 , wherein stimulating the dorsal rootlets or the lateral spinal cord does not induce paresthesia in the amputated limb.

18. The method of claim 15 , wherein the neurostimulator is an external or implanted pulse generator.

19. The method of claim 15 , further comprising implanting the neurostimulator in the subject.

20. The method of claim 15 , wherein the sensor is any one of a gyroscope, an electrogoniometer, a textile piezoresistive sensor, or a pressure sensor located in or on the limb or the prosthesis of the subject.

21. The method of claim 15 , wherein the sensor detects pressure at the fingertips of a prosthetic hand or in the sole of a prosthetic foot.

22. The method of claim 15 , wherein the sensor detects a position of the limb, the stump of the limb, the prosthesis, or the virtual prosthesis.

23. The method of claim 15 , wherein the virtual prosthesis of the limb is a computer-generated image of the limb and the movement of the computer-generated image of the limb is observed or controlled by the subject.

24. The method of claim 15 , further comprising selecting the subject with the amputated limb with the prosthesis for treatment.

25. The method of claim 15 , wherein providing the therapeutically effective amount of stimulation comprises applying electrical stimulation at a frequency of from 1-300 Hz, an amplitude of from 0.1-10 mA, and a pulse duration of from 50-500 μsec, to the dorsal rootlets or the lateral spinal cord adjacent to the dorsal rootlets innervating the amputated limb of the subject.

26. The method of claim 15 , wherein the neurostimulator is implanted at the dorsal rootlets of the sensory neurons innervating the amputated limb of the subject.

27. The method of claim 15 , wherein the neurostimulator is implanted at the lateral spinal cord adjacent to the dorsal rootlets of the sensory neurons innervating the amputated limb of the subject.

28. The method of claim 15 , wherein increasing control of the prosthetic limb of the subject increases postural balance in the subject by at least 50% as measured using a sensory organization test.

Assignees

• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education

Inventors

• Fisher Lee Erik Bartholomew
• Gaunt Robert A
• Weber Douglas J

Classifications

• A61B5/4005

  for evaluating the sensory system (A61B5/12, A61B5/4058 take precedence) · CPC title

• A61N1/36071 Primary

  Pain · CPC title

• A61B2505/09

  Rehabilitation or training · CPC title

• A61B5/6811

  External prosthesis · CPC title

• A61N1/36031

  using physiological parameters for adjustment · CPC title