Patient sensory response evaluation for neuromodulation efficacy rating

• US 7,206,632 B2
• Filed: 01/30/2004
• Issued: 04/17/2007
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: King, Gary W.
• Primary Examiner(s): Marmor, II; Charles
• Application Number:
  US10/768,352
• Publication Number:
  US 20050075669A1
• Time in Patent Office: 1,173 Days
• Field of Search: 600/544, 600/545, 600552-555, 607/2
• US Class Current: 600/544
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training

Abstract

The invention is directed to a technique for rating neuromodulation efficacy based on evaluation of the response of the patient to sensory stimuli with and without delivery of neuromodulation therapy. In addition, the invention may provide a system capable of delivering sensory stimuli on a quantitative basis in a coordinated manner with delivery of neuromodulation therapy. A device programmer may provide a platform for controlling delivery of the sensory stimuli, delivery of neuromodulation therapy, and generation of rating information for neuromodulation efficacy based on patient sensory response to the stimuli. In operation, the programmer controls application of selected sensory stimuli to the patient'"'"'s body and records the patient'"'"'s verbal or physiological responses to the stimuli. This invention can be used to be a diagnostic or prognostic test that a given neuromodulation therapy, such as neurostimulation or drug delivery, is and will be successful.

Claims

1. A method comprising:

applying a first type of external sensory stimulation to a patient;

obtaining a baseline measurement of patient sensory response to the first type of external sensory stimulation;

applying a second type of external sensory stimulation to a patient;

obtaining a baseline measurement of patient sensory response to the second type of external sensory stimulation;

applying neuromodulation therapy to the patient simultaneously with application of the first type of external sensory stimulation;

obtaining a test measurement of patient sensory response to the first type of external sensory stimulation during simultaneous application of the first type of external sensory stimulation and the neuromodulation therapy;

applying neuromodulation therapy to the patient simultaneously with application of the second type of external sensory stimulation;

obtaining a test measurement of patient sensory response to the second type of external sensory stimulation during simultaneous application of the second type of external sensory stimulation and the neuromodulation therapy;

evaluating efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements.

2. The method of claim 1, wherein evaluating efficacy includes at least one of evaluating diagnostic efficacy and prognostic efficacy.

3. The method of claim 1, wherein applying neuromodulation therapy includes at least one of applying neurostimulation therapy and drug delivery therapy.

4. The method of claim 3, wherein the drug delivery therapy includes at least one of delivery of a drug orally, by injection, by implantable drug pump, by external drug pump, and by transdermal patch.

5. The method of claim 1, wherein applying neuromodulation therapy includes applying neurostimulation therapy via one or more implanted neurostimulation leads.

6. The method of claim 1, wherein applying neuromodulation therapy includes applying neurostimulation therapy by transcutaneous electrical nerve stimulation.

7. The method of claim 1, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, electrical, and chemical stimulation.

8. The method of claim 1, wherein the patient sensory response includes at least one of a perception threshold, a pain threshold, and a tolerance limit.

9. The method of claim 8, wherein the patient report includes input indicated in a visual analog scale format.

10. The method of claim 1, wherein the patient sensory response includes a patient report relating to perceived pain relief.

11. The method of claim 1, further comprising performing the method in one of a clinic and a patient home.

12. The method of claim 1, further comprising using an integrated device to apply at least one of the first and second types of external sensory stimulation and to control the application of the neurostimulation therapy.

13. The method of claim 1, further comprising using a device to control both a quantitative sensory testing device to apply at least one of the first and second types of external sensory stimulation and a neuromodulation device to apply the neuromodulation therapy.

14. The method of claim 1, wherein one of the first and second types of external sensory stimulation includes electrical stimulation.

15. The method of claim 1, wherein one of the first and second types of external sensory stimulation includes vibratory stimulation.

16. The method of claim 1, wherein the first type of external sensory stimulation includes vibratory stimulation, and the second type of external sensory stimulation includes electrical stimulation.

17. The method of claim 1, wherein applying neuromodulation therapy includes applying different neurostimulation programs, the method further comprising obtaining multiple test measurements of patient sensory response to the first and second types of external sensory stimulation during application of the different neurostimulation programs, and identifying favorable neurostimulation programs based on the comparison of the baseline measurements and the test measurements for the first and second types of external sensory stimulation.

18. The method of claim 1, further comprising repeating the measurements following implant of an implantable neurostimulator in the patient.

19. The method of claim 18, wherein the application of a drug includes at least one of topical application and intraspinal application of the drug.

20. The method of claim 1, wherein the external sensory stimulation includes application of a drug to the patient.

21. A system comprising:

a first sensory stimulation unit to apply a first type of external sensory stimulation to a patient;

a second sensory stimulation unit to apply a second type of external sensory stimulation to the patient;

a neuromodulation unit to apply neuromodulation therapy to the patient;

a device to obtain a baseline measurement of patient sensory response to the first type of external sensory stimulation without application of the neuromodulation therapy, obtain a baseline measurement of patient sensory response to the second type of external sensory stimulation without application of the neuromodulation therapy, obtain a test measurement of patient sensory response to simultaneous application of the first type of external sensory stimulation and the neuromodulation therapy, obtain a test measurement of patient sensory response to simultaneous application of the second type of external sensory stimulation and the neuromodulation therapy, and evaluate efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements.

22. The system of claim 21, wherein the first and second stimulation units are integrated within a common stimulation unit.

23. The system of claim 21, wherein the device evaluates at least one of diagnostic efficacy and prognostic efficacy.

24. The system of claim 21, wherein the neuromodulation therapy includes at least one of neurostimulation therapy and drug delivery therapy.

25. The system of claim 24, wherein the drug delivery therapy includes one of delivery of a drug by injection, by implantable drug pump, by external drug pump, and by transdermal patch.

26. The system of claim 21, wherein the neuromodulation unit includes an implantable neurostimulation unit.

27. The system of claim 21, wherein the neuromodulation unit includes a transcutaneous electrical nerve stimulation unit.

28. The system of claim 21, wherein the device includes a programmer that controls the neuromodulation unit.

29. The system of claim 28, wherein the programmer also controls the sensory stimulation unit.

30. The system of claim 21, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, electrical, and chemical stimulation.

31. The system of claim 21, wherein one of the first and second types of external sensory stimulation includes electrical stimulation.

32. The system of claim 21, wherein one of the first and second types of external sensory stimulation includes vibratory stimulation.

33. The system of claim 21, wherein the first type of external sensory stimulation includes vibratory stimulation and the second type of external sensory stimulation includes electrical stimulation.

34. The system of claim 21, wherein the patient sensory response includes at least one of a perception threshold, a pain threshold, and a tolerance limit.

35. The system of claim 21, wherein the patient sensory response includes a patient report relating to perceived pain relief.

36. The system of claim 35, wherein the patient report includes input indicated in a visual analog scale format.

37. The system of claim 21, wherein the neuromodulation unit applies different neurostimulation programs, and the device obtains multiple test measurements of patient sensory response to the first and second types of external sensory stimulation during application of the different neurostimulation programs, and identifies favorable neurostimulation programs based on the comparison of the baseline measurements and the test measurements for the first and second types of external sensory stimulation.

38. The system of claim 21, wherein the external sensory stimulation includes application of a drug to the patient.

39. The system of claim 38, wherein the application of a drug includes at least one of topical application and intraspinal application of the drug.

40. A method comprising:

applying a first type of external sensory stimulation to a patient;

obtaining a baseline measurement of patient sensory response to the first type of external sensory stimulation;

applying a second type of external sensory stimulation to a patient;

obtaining a baseline measurement of patient sensory response to the second type of external sensory stimulation;

applying neuromodulation therapy to the patient simultaneously with application of the first type of external sensory stimulation;

obtaining a test measurement of patient sensory response to the first type of external sensory stimulation during simultaneous application of the first type of external sensory stimulation and the neuromodulation therapy;

evaluating efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements for the first type of external sensory stimulation;

if the evaluation indicates efficacy, applying neuromodulation therapy to the patient simultaneously with application of the second type of external sensory stimulation;

obtaining a test measurement of patient sensory response to the second type of external sensory stimulation during simultaneous application of the second type of external sensory stimulation and the neuromodulation therapy; and

evaluating efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements for the first and second types of external sensory stimulation.

41. A system comprising:

a first sensory stimulation unit to apply a first type of external sensory stimulation to a patient;

a second sensory stimulation unit to apply a second type of external sensory stimulation to the patient;

a neuromodulation unit to apply neuromodulation therapy to the patient;

a device to obtain a baseline measurement of patient sensory response to the first type of external sensory stimulation without application of the neuromodulation therapy, obtain a baseline measurement of patient sensory response to the second type of external sensory stimulation without application of the neuromodulation therapy, obtain a test measurement of patient sensory response to simultaneous application of the first type of external sensory stimulation and the neuromodulation therapy, evaluate efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements,

wherein device, if the evaluation indicates efficacy, obtains a test measurement of patient sensory response to simultaneous application of the second type of external sensory stimulation and the neuromodulation therapy, and evaluating efficacy of the neuromodulation therapy based on a comparison of the baseline measurements and the test measurements for the first and second types of external sensory stimulation.