System and method of assessment of the efficacy of treatment of neurological disorders using the electroencephalogram

• US 7,418,290 B2
• Filed: 05/06/2004
• Issued: 08/26/2008
• Est. Priority Date: 05/06/2003
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Aspect Medical Systems, Inc. (Medtronic Plc)
• Inventors: Devlin, Philip H., Greenwald, Scott D.
• Primary Examiner(s): Nasser, Jr.; Robert L.
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US10/840,343
• Publication Number:
  US 20050043774A1
• Time in Patent Office: 1,573 Days
• Field of Search: 600/544, 600/545, 600/300, 600/301
• US Class Current: 600/544
• 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 5/6814 Head
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Disclosed is a system and method of assessing the efficacy of treatment of neurological or psychological disorders. The preferred embodiment uses at least two surface electrodes to acquire EEG signals from the surface of a patient'"'"'s body, a processor for computing from the EEG signals various features and indices that are representative of the patient'"'"'s neurological or psychological state. Changes in these parameters may be used to assess the efficacy of treatment and to modify the treatment to optimize the resultant patient state.

Claims

1. A system for assessing the efficacy of treatment of a neurological disorder comprising:

at least two electrodes for acquiring electrophysiological signals from the body suffering from a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

a processor for calculating from said electrophysiological signals at least one feature relating to the efficacy of said treatment without referencing said at least one feature to a normative data set, said at least one feature being a measure of a self-reported mood or anxiety score.

2. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said treatment is neurostimulation.

3. The system for assessing the efficacy of treatment of a neurological disorder of claim 2 wherein said neurostimulation is deep brain stimulation.

4. The system for assessing the efficacy of treatment of a neurological disorder of claim 2 wherein said neurostimulation is vagus nerve stimulation.

5. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said treatment is the administration of a pharmacological agent.

6. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said treatment is electroconvulsive therapy.

7. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said treatment is transcranial magnetic stimulation.

8. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said processor calculates at least two features and combines said at least two features into an index.

9. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said processor calculates at least one feature from a spectral array.

10. The system for assessing the efficacy of treatment of a neurological disorder of claim 8 wherein said processor calculates at least one feature from a power spectral array.

11. The system for assessing the efficacy of treatment of a neurological disorder of claim 8 wherein said processor calculates at least one feature from a bispectral array.

12. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said at least one feature is a time domain feature.

13. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said at least two electrodes are placed in a bilateral montage.

14. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said at least two electrodes are placed in an unilateral montage.

15. The system for assessing the efficacy of treatment of a neurological disorder of claim 1 wherein said feature is the interhemispheric difference in a metric calculated from each electrophysiological signal.

16. The system for assessing the efficacy of treatment of a neurological disorder of claim 15 wherein said metric is a spectral feature.

17. The system for assessing the efficacy of treatment of a neurological disorder of claim 15 wherein said metric is a time domain feature.

18. A system for assessing the efficacy of treatment of a neurological disorder comprising:

at least two electrodes for acquiring electrophysiological signals from a body suffering from a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

data acquisition circuitry for acquiring from said electrodes a first electrophysiological signal representing a baseline condition and a second electrophysiological signal representing a subsequent condition;

a processor for calculating from said electrophysiological signals received from the data acquisition circuitry;

(a) at least one feature relating to the patient state during the baseline condition, without referencing said at least one feature relating to the patient state during the baseline condition to a normative data set, said at least one feature relating to the patient state during the baseline condition being a measure of a self-reported mood or anxiety score;

(b) at least one feature relating to the patient state during the subsequent condition, without referencing said at least one feature relating to the patient state during the subsequent condition to a normative data set, said at least one feature relating to the patient state during the subsequent condition being a measure of a self-reported mood or anxiety score; and

(c) the difference between said features relating to the baseline and subsequent conditions, such that said difference relates to the efficacy of said treatment.

19. A system for optimizing the efficacy of treatment of a neurological disorder comprising:

at least two electrodes for acquiring electrophysiological signals from a body suffering from a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

processor for calculating from said electrophysiological signals at least one feature relating to the efficacy of said treatment without referencing said at least one feature to a normative data set, said feature being a measure of a self-reported mood or anxiety score;

data acquisition circuitry for acquiring said electrophysiological signals from said electrodes and converting said electrophysiological signals to a form usable by said processor;

a processor for varying the treatment parameters of a neurostimulator in order to maximize the calculated treatment efficacy.

20. A method of assessing the efficacy of treatment of a neurological disorder comprising the steps of:

acquiring electrophysiological signals from a body suffering from a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, said signals being acquired through electrodes placed on the body, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

calculating from said electrophysiological signals at least one feature relating to the efficacy of said treatment without referencing said at least one feature to a normative data set, said feature being a measure of a self-reported mood or anxiety score.

21. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said treatment is neurostimulation.

22. The method of assessing the efficacy of treatment of a neurological disorder of claim 21 wherein said neurostimulation is deep brain stimulation.

23. The method of assessing the efficacy of treatment of a neurological disorder of claim 21 wherein said neurostimulation is vagus nerve stimulation.

24. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said treatment is the administration of a pharmacological agent.

25. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said treatment is electroconvulsive therapy.

26. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said treatment is transcranial magnetic stimulation.

27. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 further comprising the step of combining said features into an index.

28. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said at least one feature is calculated from a spectral array.

29. The method of assessing the efficacy of treatment of a neurological disorder of claim 27 wherein said at least one feature is calculated from a power spectral array.

30. The method of assessing the efficacy of treatment of a neurological disorder of claim 27 wherein said at least one feature is calculated from a bispectral array.

31. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said at least one feature is a time domain feature.

32. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said at least two electrodes are placed in a bilateral montage.

33. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said at least two electrodes are placed in an unilateral montage.

34. The method of assessing the efficacy of treatment of a neurological disorder of claim 20 wherein said feature is the interhemispheric difference in a metric calculated from each electrophysiological signal.

35. The method of assessing the efficacy of treatment of a neurological disorder of claim 34 wherein said metric is a spectral feature.

36. The method of assessing the efficacy of treatment of a neurological disorder of claim 34 wherein said metric is a time domain feature.

37. A method of assessing the efficacy of treatment of a neurological disorder comprising:

positioning a least two electrodes on a body being treated for a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

acquiring a first electrophysiological signal from the body at a baseline condition;

acquiring a second electrophysiological signal from the body during a subsequent condition;

calculating at least one feature relating to the patient state during the baseline condition without referencing said at least one feature relating to the patient state during the baseline condition to a normative data set, said at least one feature relating to the patient state during the baseline condition being a measure of a self-reported mood or anxiety score;

calculating at least one feature relating to the patient state during the subsequent condition without referencing said at least one feature relating to the patient state during the subsequent condition to a normative data set, said at least one feature relating to the patient state during the subsequent condition being a measure of a self-reported mood or anxiety score;

calculating at the difference between the features calculated during the baseline and subsequent conditions, such that the difference relates to the efficacy of said treatment.

38. A method of optimizing the efficacy of treatment of a neurological disorder comprising:

positioning at least two electrodes on a body being treated for a neurological disorder which is one or more of depression, major depressive disorder, obsessive compulsive disorder, dementia, mood disorders and anxiety disorders, wherein one of said at least two electrodes for acquiring electrophysiological signals from the body is positioned at electrode position Fp_z;

acquiring electrophysiological signals from the body;

calculating at least one feature relating to the efficacy of said treatment without referencing said at least one feature to a normative data set, said at least one feature being a measure of a self-reported mood or anxiety score;

varying treatment parameters in order to maximize the calculated treatment efficacy.