Patient sensory response evaluation for neuromodulation efficacy rating

• US 7,367,956 B2
• Filed: 08/02/2006
• Issued: 05/06/2008
• 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): Nasser, Jr.; Robert L.
• Assistant Examiner(s): Toth; Karen E.
• Application Number:
  US11/497,939
• Publication Number:
  US 20060270944A1
• Time in Patent Office: 643 Days
• Field of Search: 600/544, 600/545, 600/554
• US Class Current: 600/554
• 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 external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, and chemical stimulation;

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

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

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

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

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

3. The method of claim 2, 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.

4. The method of claim 1, wherein applying neuromodulation therapy includes applying neurostimulation therapy.

5. 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.

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

7. The method of claim 6, wherein the patient report includes input indicated in a visual analog scale format.

8. 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 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 external sensory stimulation.

9. The method of claim 8, wherein the external sensory stimulation includes application of a drug to the patient.

10. The method of claim 9, wherein the application of a drug includes at least one of topical application and intraspinal application of the drug.

11. A system comprising:

a sensory stimulation unit to apply external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, and chemical stimulation;

a neuromodulation unit to apply neuromodulation therapy to the patient;

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

12. The system of claim 11, wherein the neuromodulation therapy includes at least one of neurostimulation therapy and drug delivery therapy.

13. The system of claim 12, 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.

14. The system of claim 11, wherein the neuromodulation unit includes a neurostimulation unit.

15. The system of claim 11, wherein the device includes a programmer that controls the neuromodulation unit and the sensory stimulation unit.

16. The system of claim 11, wherein the patient sensory response includes at least one of a perception threshold, a pain threshold, and a tolerance limit.

17. The system of claim 11, wherein the patient sensory response includes a patient report relating to perceived pain relief.

18. The system of claim 17, wherein the patient report includes input indicated in a visual analog scale format.

19. The system of claim 11, 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.

20. The system of claim 11, wherein the external sensory stimulation includes application of a drug to the patient.

21. The system of claim 20, wherein the application of a drug includes at least one of topical application and intraspinal application of the drug.

22. A method comprising:

applying external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, and chemical stimulation;

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

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

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

evaluating prognostic efficacy of the neuromodulation therapy based on a comparison of the baseline measurements, the test measurements, and a patient report of pain relief.

23. The method of claim 22, wherein the patient report of pain relief includes at least one of a report of percentage of pain relief, a visual analog scale (VAS) score, and a word choice.

24. A system comprising:

a sensory stimulation unit to apply external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, and chemical stimulation;

a neuromodulation unit to apply neuromodulation therapy to the patient simultaneously with application of the external sensory stimulation; and

a device to obtain a baseline measurement of patient sensory response to the external sensory stimulation, obtain a test measurement of patient sensory response to the external sensory stimulation during simultaneous application of the external sensory stimulation and the neuromodulation therapy, and evaluate prognostic efficacy of the neuromodulation therapy based on a comparison of the baseline measurements, the test measurements, and a patient report of pain relief.

25. The method of claim 24, wherein the patient report of pain relief includes at least one of a report of percentage of pain relief, a visual analog scale (VAS) score, and a word choice.

26. A method comprising:

applying external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, electrical, and chemical stimulation;

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

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

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

evaluating efficacy of the neuromodulation therapy based on a comparison of the baseline measurements, the test measurements, and a visual analog scale (VAS) score.

27. A system comprising:

a sensory stimulation unit to apply external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of tactile, vibrational, thermal, pressure, electrical, and chemical stimulation;

a neuromodulation unit to apply neuromodulation therapy to the patient simultaneously with application of the external sensory stimulation; and

a device to obtain a baseline measurement of patient sensory response to the external sensory stimulation, obtain a test measurement of patient sensory response to the external sensory stimulation during simultaneous application of the external sensory stimulation and the neuromodulation therapy, and evaluate efficacy of the neuromodulation therapy based on a comparison of the baseline measurements, the test measurements, and a visual analog scale (VAS) score.

28. A method comprising:

applying external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of thermal, pressure, and chemical stimulation;

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

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

obtaining a test measurement of patient sensory response to the external sensory stimulation during simultaneous application of the 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.

29. The method of claim 28, wherein evaluating efficacy includes at least one of evaluating diagnostic efficacy and prognostic efficacy.

30. The method of claim 28, wherein applying neuromodulation therapy includes at least one of applying neurostimulation therapy and drug delivery therapy.

31. A system comprising:

a sensory stimulation unit to apply external sensory stimulation to a patient, wherein the external sensory stimulation includes at least one of thermal, pressure, and chemical stimulation;

a neuromodulation unit to apply neuromodulation therapy to the patient;

a device to obtain a baseline measurement of patient sensory response to the external sensory stimulation without application of the neuromodulation therapy, obtain a test measurement of patient sensory response to simultaneous application of the 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.

32. The system of claim 31, wherein the device evaluates at least one of diagnostic efficacy and prognostic efficacy.

33. The system of claim 31, wherein the neuromodulation therapy includes at least one of neurostimulation therapy and drug delivery therapy.