Systems and Methods for Providing Targeted Neural Stimulation Therapy to Address Neurological Disorders, Including Neuropyschiatric and Neuropyschological Disorders

• US 20090149898A1
• Filed: 12/08/2008
• Published: 06/11/2009
• Est. Priority Date: 12/07/2007
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Northstar Neuroscience, Inc.
• Inventors: Soltysik, David Alan, Fowler, Brad, Hulvershorn, Justin, Gliner, Bradford Evan, Sloan, Leif R., Kopell, Brian
• Granted Patent: US 8,538,537 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Systems and methods for providing targeted neural stimulation therapy to address neurological disorders, including neuropsychiatric and neuropsychological disorders are disclosed. A method for treating a patient'"'"'s neurological disorder in accordance with a particular embodiment includes, in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, implanting at least one stimulation electrode within the patient'"'"'s skull cavity, and outside a cortical surface of the patient'"'"'s brain. The electrode is implanted at a location in a range of about 15 mm to about 35 mm anterior to a precentral sulcus reference point that is positioned at the precentral sulcus and at the patient'"'"'s middle frontal gyrus. The method can further include treating the patient'"'"'s disorder by applying electrical stimulation to the patient via the at least one stimulation electrode.

Claims

1. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, implanting at least one stimulation electrode within the patient'"'"'s skull cavity, outside a cortical surface of the patient'"'"'s brain, and at a location in a range of about 15 mm to about 35 mm anterior to a precentral sulcus reference point that is positioned (a) at the precentral sulcus and (b) at the patient'"'"'s middle frontal gyrus; and

treating the patient'"'"'s disorder by applying electrical stimulation to the patient via the at least one stimulation electrode.

2. The method of claim 1 wherein:

the at least one stimulation electrode is one of a plurality of stimulation electrodes;

all of the active stimulation electrodes implanted within the patient'"'"'s skull cavity are implanted outside the cortical surface of the patient'"'"'s brain at the patient'"'"'s middle frontal gyrus;

the at least one electrode is the posterior-most electrode within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain via which electrical stimulation is applied to the patient'"'"'s brain;

the at least one electrode is at least 18 mm anterior to the precentral sulcus reference point and is positioned superior to a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion; and

the precentral sulcus reference point is approximately at an intersection of the precentral sulcus and the linear or curvilinear line.

3. The method of claim 1 wherein the at least one electrode is the posterior-most electrode within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain via which electrical stimulation is applied to the patient'"'"'s brain.

4. The method of claim 1 wherein the precentral sulcus reference point is approximately at an intersection of the precentral sulcus and a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion.

5. The method of claim 1 wherein the precentral sulcus reference point is approximately at an anterior-most point of the precentral sulcus that abuts the middle frontal gyrus.

6. The method of claim 1 wherein implanting the at least one electrode includes implanting the at least one electrode at least 18 mm anterior to the precentral sulcus reference point.

7. The method of claim 1 wherein implanting the at least one electrode includes implanting the at least one electrode at least 20 mm anterior to the precentral sulcus reference point.

8. The method of claim 1 wherein implanting the at least one electrode includes implanting the at least one electrode at the patient'"'"'s middle frontal gyrus, approximately midway between the superior frontal sulcus and the inferior frontal sulcus.

9. The method of claim 1 wherein implanting the at least one electrode includes implanting the at least one electrode within the middle frontal gyrus and superior to a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion.

10. The method of claim 1 wherein implanting the at least one electrode includes implanting the at least one electrode at a location in a range of about 25 mm to about 85 mm anterior to the patient'"'"'s central sulcus.

12. The method of claim 1 wherein implanting at least one electrode includes implanting a plurality of electrodes, with at least one of the plurality of electrodes positioned more than 35 mm anterior to the precentral sulcus reference point.

13. The method of claim 1 wherein implanting the at least one electrode includes implanting a plurality of electrodes aligned generally parallel to a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion.

14. The method of claim 1 wherein implanting the at least one electrode includes implanting a plurality of electrodes, and wherein all of the stimulation electrodes implanted within the patient'"'"'s skull cavity are implanted outside the cortical surface of the patient'"'"'s brain at the patient'"'"'s middle frontal gyrus.

15. The method of claim 1 wherein implanting the at least one electrode includes implanting a plurality of electrodes, and wherein all of the stimulation electrodes implanted within the patient'"'"'s skull cavity are implanted outside the cortical surface of the patient'"'"'s brain at least 15 mm anterior to the precentral sulcus reference point.

16. The method of claim 1 wherein all stimulation electrodes implanted within the patient'"'"'s skull cavity are implanted outside the cortical surface of the patient'"'"'s brain, and at a location in the range of about 15 mm to about 35 mm anterior to the precentral sulcus reference point.

17. The method of claim 1, further comprising directing the patient to engage in an adjunctive therapy as part of a treatment regimen that also includes the electrical stimulation.

18. The method of claim 17 wherein the adjunctive therapy includes at least one of a drug therapy, a behavioral therapy, a cognitive behavioral therapy, counseling, and biofeedback.

19. The method of claim 1 wherein the at least one electrode is positioned within the middle third of the patient'"'"'s middle frontal gyrus, as measured along an anterior-posterior linear or curvilinear line that generally bisects the middle frontal gyms into a superior portion and an inferior portion.

20. The method of claim 1 wherein implanting the electrode includes implanting the electrode at an epidural location.

21. The method of claim 1 wherein implanting the electrode includes implanting the electrode at a subdural location.

22. The method of claim 1 wherein the patient is diagnosed with a depressive disorder.

23. The method of claim 1 wherein the patient is diagnosed with a major depressive disorder.

24. The method of claim 1 wherein the patient is diagnosed with at least one of a mood disorder, bipolar disorder, obsessive-compulsive disorder (OCD), Tourette'"'"'s syndrome, schizophrenia, a dissociative disorder, an anxiety disorder, a phobic disorder, a post-traumatic stress disorder, a borderline personality disorder, ADHD, and craving.

26. The method of claim 15 wherein:

the at least one stimulation electrode is one of a plurality of stimulation electrodes;

all of the stimulation electrodes within the patient'"'"'s skull cavity are outside the cortical surface of the patient'"'"'s brain at the patient'"'"'s middle frontal gyrus;

the at least one electrode is the posterior-most electrode within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain via which electrical stimulation is applied to the patient'"'"'s brain;

the at least one electrode is at least 18 mm anterior to the precentral sulcus reference point and is positioned superior to a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion; and

the precentral sulcus reference point is approximately at an intersection of the precentral sulcus and the linear or curvilinear line.

11. The method of 1 claim wherein implanting the at least one electrode includes implanting a plurality of electrodes, with at least one of the electrodes positioned superior to a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion, and with at least another of the electrodes positioned inferior to the line.

25. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, preferentially directing electrical stimulation to a target location of the patient'"'"'s brain, the target location being in a range of about 15 mm to about 35 mm anterior to a precentral sulcus reference point that is positioned (a) at the precentral sulcus and (b) at the patient'"'"'s middle frontal gyrus, with the electrical stimulation being directed from at least one stimulation electrode positioned within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain.

27. The method of claim 25, further comprising directing the patient to engage in an adjunctive therapy as part of a treatment regimen that also includes the electrical stimulation.

28. The method of claim 27 wherein the adjunctive therapy includes at least one of a drug therapy, a behavioral therapy, a cognitive behavioral therapy, counseling, and biofeedback.

29. The method of claim 25 wherein the patient is diagnosed with a depressive disorder.

30. The method of claim 25 wherein the patient is diagnosed with at least one of a mood disorder, bipolar disorder, obsessive-compulsive disorder (OCD), Tourette'"'"'s syndrome, schizophrenia, a dissociative disorder, an anxiety disorder, a phobic disorder, a post-traumatic stress disorder, a borderline personality disorder, ADHD, and craving.

31. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, implanting first and second electrodes within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain, the first electrode being located at one of Brodmann areas 6, 8, 9, 9/8, 10, 46 and 9/46, the second electrode being located at another of Brodmann areas 6, 8, 9, 9/8, 10, 46 and 9/46; and

treating the patient'"'"'s disorder by applying electrical stimulation to the patient via the first and second electrodes.

32. The method of claim 31, further comprising implanting at least one of the first and second electrodes at a location in a range of about 15 mm to about 35 mm anterior to a precentral sulcus reference point that is positioned (a) at the precentral sulcus and (b) at the patient'"'"'s middle frontal gyrus.

33. The method of claim 31 wherein implanting the first and second electrodes includes implanting one of the first and second electrodes at Brodmann area 6 and implanting the other of the first and second electrodes at Brodmann area 8.

34. The method of claim 31 wherein implanting the first and second electrodes includes implanting one of the first and second electrodes at Brodmann area 8 and implanting the other of the first and second electrodes at Brodmann area 9.

35. The method of claim 31 wherein implanting the first and second electrodes includes implanting one of the first and second electrodes at Brodmann area 8 and implanting the other of the first and second electrodes at Brodmann area 10.

36. The method of claim 31 wherein implanting the first and second electrodes includes implanting one of the first and second electrodes at Brodmann area 9/46 and implanting the other of the first and second electrodes at Brodmann area 8.

37. The method of claim 31 wherein all stimulation electrodes implanted within the patient'"'"'s skull cavity are implanted outside a cortical surface of the patient'"'"'s brain and within two or more of Brodmann areas 6, 8, 9, 10 and 9/46.

38. The method of claim 31, further comprising:

implanting a third electrode at still another of Brodmann areas 6, 8, 9, 10, 46 and 9/46; and

treating the patient'"'"'s disorder by applying stimulation to the patient via the first, second and third electrodes.

39. The method of claim 38 wherein implanting the first, second and third electrodes includes implanting one of the electrodes at Brodmann area 8, another of the electrodes at Brodmann area 9, and still another of the electrodes at Brodmann area 10.

40. The method of claim 39, further comprising:

implanting a fourth electrode at one of Brodmann area 9/46 and Brodmann area 6; and

treating the patient'"'"'s disorder by applying stimulation to the patient via the first, second, third and fourth electrodes.

41. The method of claim 31 wherein the patient is diagnosed with a major depressive disorder.

42. The method of claim 31, further comprising directing the patient to engage in an adjunctive therapy as part of a treatment regimen that also includes the electrical stimulation.

43. The method of claim 42 wherein the adjunctive therapy includes at least one of a drug therapy, a behavioral therapy, a cognitive behavioral therapy, counseling, and biofeedback.

44. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, implanting first and second electrodes within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain, the first electrode being located at the frontal cortical lobe of the brain, the second electrode being located at an auditory processing area of the brain; and

treating the patient'"'"'s disorder by applying stimulation to the patient via the first and second electrodes.

45. The method of claim 44 wherein implanting the first electrode includes implanting the first electrode at the dorsolateral prefrontal cortex.

46. The method of claim 44 wherein implanting the first electrode includes implanting the first electrode at one of the dorsolateral prefrontal cortex, the orbitofrontal cortex, and the ventrolateral prefrontal cortex.

47. The method of claim 44 wherein implanting the first electrode includes implanting the first electrode at one of Brodmann area 6, Brodmann area 8, Brodmann area 9, Brodmann area 9/8, Brodmann area 10, Brodmann area 46, and Brodmann area 9/46.

48. The method of claim 44 wherein implanting the second electrode includes implanting the second electrode at one of the posterior lateral superior temporal gyrus, the supramarginal gyrus, and the angular gyrus.

49. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, implanting at least one electrode within the patient'"'"'s skull cavity, outside a cortical surface of the patient'"'"'s brain, and at or anterior to a reference position in a range of about 2 mm to about 12 mm posterior to the coronal suture of the patient'"'"'s skull; and

treating the patient'"'"'s disorder by applying electrical stimulation to the patient via the at least one electrode.

50. The method of claim 49 wherein the range is relative to an anterior edge of the coronal suture.

51. The method of claim 49 wherein the distance between the reference position and the coronal suture is measured generally along a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion.

52. The method of claim 49 wherein implanting at least one electrode includes implanting a plurality of electrodes with a posterior edge of a posterior-most electrode at or anterior to the reference position.

53. A method for treating a patient'"'"'s neurological disorder, comprising:

in a patient identified as having at least one of a neuropsychological disorder and a neuropsychiatric disorder, preferentially directing electrical stimulation to a target location of the patient'"'"'s brain, the target location being at or anterior to a reference position in a range of about 2 mm to about 12 mm posterior to the coronal suture of the patient'"'"'s skull, with the electrical stimulation being directed from at least one electrode positioned within the patient'"'"'s skull cavity and outside a cortical surface of the patient'"'"'s brain.

54. The method of claim 53 wherein the range is relative to an anterior edge of the coronal suture.

55. The method of claim 53 wherein the distance between the reference position and the coronal suture is measured generally along a linear or curvilinear line that at least approximately bisects the middle frontal gyrus into a superior portion and an inferior portion.

56. The method of claim 53 wherein implanting at least one electrode includes implanting a plurality of electrodes with a posterior edge of a posterior-most electrode at or anterior to the reference position.

57. The method of claim 53 wherein implanting at least one electrode includes implanting a plurality of electrodes with a posterior edge of a posterior-most electrode positioned in a superior portion of the middle frontal gyrus.

58. A computer-implemented method for identifying target stimulation regions for treating a patient'"'"'s neurological disorder, comprising:

receiving machine-readable data corresponding to an individual patient'"'"'s brain structures;

determining a set of transformation values correlating the individual patient'"'"'s brain structures with brain structures of a standard brain atlas;

receiving input corresponding to a portion of a brain structure at which stimulation electrodes are to be positioned and a target minimum distance from a reference anatomical structure, the input being referenced to one of the standard brain atlas and the individual patient'"'"'s brain structures; and

based at least in part on the transformation values, mapping the received input to be with reference to the other the standard brain atlas and the individual patient'"'"'s brain structures.

59. The computer-implemented method of claim 58 wherein receiving input includes receiving an input identifying the middle third of the middle frontal gyrus with reference to the standard brain atlas, and wherein mapping includes mapping the middle third of the middle frontal gyrus from the standard atlas to an image of the patient'"'"'s brain, and wherein the method further comprises displaying an image of the patient'"'"'s brain with the middle third of the middle frontal gyrus highlighted.

60. The computer-implemented method of claim 58 wherein receiving input includes receiving an input identifying an offset distance from precentral sulcus with reference to the standard brain atlas, and wherein mapping includes mapping the offset distance from the standard atlas to an image of the patient'"'"'s brain, and wherein the method further comprises displaying an image of the patient'"'"'s brain with the offset distance highlighted.

61. The computer-implemented method of claim 58 wherein receiving input includes receiving an input identifying a selected region of the individual patient'"'"'s brain with reference to the individual patient'"'"'s brain structures, and wherein the method further comprises:

comparing the selected region to a predefined region of the standard brain atlas; and

displaying a comparison of the selected region and the predefined region of the standard brain atlas.

62. The computer-implemented method of claim 58 wherein receiving input includes receiving input from a user via at least one of a keyboard, mouse, electronic touch screen.

67. The computer-implemented method of claim 62 wherein the locating information includes a distance relative to a coronal suture reference point.

63. A computer-implemented method for identifying target stimulation regions for treating a patient'"'"'s neurological disorder, comprising:

based at least part on efficacy data from multiple patients receiving electrical stimulation from geometrically similar multi-electrode devices for treatment of at least one of a neuropsychological disorder and a neuropsychiatric disorder, determining locating information for positioning a geometrically similar multi-electrode device in another individual patient, wherein the locating information includes an orientation of the multi-electrode device and an offset distance between at least one electrode of the multi-electrode device and an anatomical brain feature, and wherein the locating information corresponds to an electrode device position expected to produce efficacious results in the individual patient;

applying the locating information to a standard brain atlas; and

defining an electrode mask based on the locating information, wherein the electrode mask includes brain atlas coordinates for at least on electrode.

64. The computer-implemented method of claim 63, further comprising:

determining a set of transformation values correlating the individual patient'"'"'s brain structures with brain structures of the standard brain atlas; and

based at least in part on the transformation values, mapping the locating information to be with reference to the individual patient'"'"'s brain structures.

65. The computer-implemented method of claim 63 wherein the locating information includes a distance relative to a precentral sulcus reference point.

66. The computer-implemented method of claim 63 wherein the locating information includes a distance relative to a central sulcus reference point.