Method and Apparatus for the Treatment of Movement Disorders

• US 20070225674A1
• Filed: 11/30/2006
• Published: 09/27/2007
• Est. Priority Date: 03/24/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Werder, Jonathan C., Giftakis, Jonathon E., Molnar, Gregory F., Carlson, David L., Miesel, Keith A., Miyazawa, Gabriela C.
• Granted Patent: US 8,190,251 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003

Abstract

A method, apparatus, and system for treating patients suffering from movement disorders having the ability to determine one or more biomarkers indicative of a disease state. In some embodiments, the biomarker may be used as a closed-loop feedback signal to control the delivery of therapy (such as electrical stimulation or drug therapy), and which may also be used as an indication of therapy effectiveness. One embodiment uses electrodes placed in the brain to measure EEG or local field potential (LFP) signals, from which the one or more biomarkers may be determined.

Claims

1. A method of treating a neurological movement disorder, the method comprising:

acquiring a physiological signal from a brain of a patient;

measuring a first value from the physiological signal, the first value representative of an

amount of oscillatory activity in a first frequency range;

measuring a second value from the physiological signal, the second value representative of an

amount of oscillatory activity in a second frequency range;

calculating a biomarker as a function of the first and second values; and

using the biomarker to assess the movement disorder.

2. The method of claim 1 wherein the movement disorder is Parkinson'"'"'s Disease.

3. The method of claim 1 wherein the movement disorder is dystonia.

4. The method of claim 1 wherein the first frequency range is from about 7 to 35 Hz, and wherein the second frequency range is greater than about 50 Hz.

5. The method of claim 4 wherein the first frequency range is from about 11 to 30 Hz, and wherein the second frequency range is between about 60 and 300 Hz.

6. The method of claim 1 wherein calculating the biomarker includes determining a ratio from the first and second values.

7. The method of claim 6 wherein calculating the biomarker includes determining the ratio of the first value to the second value.

8. The method of claim 7 wherein the biomarker is compared to a reference value to assess the movement disorder.

9. The method of claim 8 wherein the biomarker exceeding the reference value indicates a worsening of the movement disorder.

10. The method of claim 1 wherein the physiological signal is a local field potential (LFP) signal.

11. The method of claim 1 wherein the physiological signal is an electroencephalogram (EEG) signal.

12. The method of claim 1 wherein the physiological signal is an electrocorticogram (ECoG) signal acquired by one or more deep brain stimulation (DBS) electrodes located in the brain of the patient.

13. The method of claim 1 wherein the physiological signal includes a plurality of signals obtained from a plurality of leads.

14. The method of claim 13 wherein the plurality of signals are obtained from a plurality of locations within the brain of the patient.

15. The method of claim 1 wherein the measured first and second values representative of an amount of oscillatory activity are at least partially based on an energy level of the physiological signal within the respective first and second frequency ranges.

16. The method of claim 1 wherein the measured first and second values representative of an amount of oscillatory activity are at least partially based on an amplitude of the physiological signal within the respective first and second frequency ranges.

17. The method of claim 1 wherein the measured first and second values representative of an amount of oscillatory activity are at least partially based on a frequency of the physiological signal within the respective first and second frequency ranges.

18. The method of claim 1 further comprising delivering treatment to the patient based on the calculated value of the biomarker.

19. The method of claim 18 wherein treatment is delivered to the patient based upon the biomarker exceeding a reference value.

20. The method of claim 18 wherein treatment comprises electrical stimulation therapy.

21. The method of claim 18 wherein treatment comprises drug delivery therapy.

22. The method of claim 21 wherein drug delivery therapy is provided via an infusion pump adapted to deliver a drug to a portion of the patient'"'"'s body.

23. The method of claim 22 wherein the infusion pump is adapted to deliver a drug to the patient'"'"'s brain via an intracerebroventricular catheter.

24. The method of claim 22 wherein the infusion pump is adapted to deliver a drug to the patient'"'"'s brain via an intraparenchymal catheter.

25. The method of claim 18 wherein the biomarker is re-calculated in conjunction with delivery of treatment to provide closed-loop control of said treatment.

26. The method of claim 25 wherein treatment is varied to achieve a biomarker value within a predefined range.

27. The method of claim 18 wherein treatment delivered in a first region of the brain may be different from treatment delivered in a second region of the brain.

28. The method of claim 18 wherein the treatment delivered may be varied according to a desired patient outcome.

29. The method of claim 28 wherein the desired patient outcome is improved manual dexterity.

30. The method of claim 28 wherein the desired patient outcome is a reduction in tremors.

31. The method of claim 18 wherein the treatment delivered may be varied by changing the programmed settings in an implantable device.

32. The method of claim 1 wherein at least one of the measured first and second values representative of an amount of oscillatory activity is determined using an order statistic filter.

33. The method of claim 32 wherein the measured first and second values are determined using a cascaded median filter.

34. The method of claim 1 further comprising:

measuring a third value from the physiological signal, the third value representative of an amount of oscillatory activity in a third frequency range;

calculating a biomarker as a function of the first, second, and third values; and

using the biomarker to assess the movement disorder.

35. A system for treating a neurological movement disorder, the system comprising:

an implantable medical device having a housing for a power supply, memory, and electronic circuitry; and

at least one electrode in communication with the device for acquiring a physiologic signal from a brain of a patient, the device being adapted to

acquire the physiological signal from the brain of the patient;

measure a first value from the physiological signal, the first value representative of an amount of oscillatory activity in a first frequency range;

measure a second value from the physiological signal, the second value representative of an amount of oscillatory activity in a second frequency range;

calculate a biomarker from the first and second values; and

use the biomarker to assess the movement disorder, the biomarker being based on a comparison of the first and second values, and the first and second frequency ranges comprising beta and gamma frequency ranges.

36. The system of claim 35 wherein calculating the biomarker includes determining a ratio of the first and second values.

37. The system of claim 35 further comprising delivering treatment to the patient based on the calculated value of the biomarker.

38. A computer-readable medium programmed with instructions for performing a method of treating a neurological movement disorder, the medium comprising instructions for causing a programmable processor to:

acquire a physiological signal from a brain of a patient;

measure a first value from the physiological signal, the first value representative of an amount of oscillatory activity in a first frequency range;

measure a second value from the physiological signal, the second value representative of an amount of oscillatory activity in a second frequency range;

calculate a biomarker from the first and second values; and

use the biomarker to assess the movement disorder, the biomarker being based on a comparison of the first and second values, and the first and second frequency ranges comprising beta and gamma frequency ranges.

39. The medium of claim 38 wherein calculating the biomarker includes determining a ratio of the first and second values.

40. The medium of claim 38 further comprising delivering treatment to the patient based on the calculated value of the biomarker.

41. An implantable medical device (IMD) for treating neurological movement disorders, the device comprising:

one or more electrodes for acquiring a physiological signal from a brain of a patient;

a processing subsystem adapted to determine a first value and a second value from the physiological signal, the first value representative of an amount of oscillatory activity in a first frequency range, the second value representative of an amount of oscillatory activity in a second frequency range, the processing subsystem further adapted to calculate a biomarker as a function of the first and second values, the biomarker providing an assessment of the movement disorder.

42. The IMD of claim 41 further comprising:

a therapy delivery subsystem adapted to deliver therapy to the patient based on the calculated value of the biomarker.

43. The IMD of claim 41 wherein the biomarker is used as a closed-loop feedback parameter to optimize therapy delivery.

44. The IMD of claim 42, wherein the therapy delivery subsystem is adapted to provide electrical stimulation therapy delivery.

45. The IMD of claim 42, wherein the therapy delivery subsystem is adapted to control drug therapy delivery.

46. A method of treating a neurological movement disorder, the method comprising:

acquiring a physiological signal from a brain of a patient;

measuring a first value from the physiological signal, the first value representative of an amount of oscillatory activity in a first frequency range;

calculating a biomarker as a function of the first value; and

using the biomarker to assess the movement disorder.

47. The method of claim 46 further comprising delivering treatment to the patient based on the calculated value of the biomarker exceeding a predetermined threshold.

48. The method of claim 46 wherein the first frequency range is from about 0 to 50 Hz.

49. The method of claim 46 wherein the first frequency range is from about 50 to 1000 Hz.

50. The method of claim 46 wherein the physiological signal includes a plurality of signals obtained from a plurality of leads.

51. The method of claim 47 wherein treatment comprises electrical stimulation therapy.

52. The method of claim 47 wherein treatment comprises drug delivery therapy.

53. The method of claim 47 wherein the biomarker is re-calculated in conjunction with delivery of treatment to provide closed-loop control of said treatment.

54. The method of claim 47 wherein treatment is varied to achieve a biomarker value within a predefined range.