Systems and methods for varying electromagnetic and adjunctive neural therapies

• US 20070179558A1
• Filed: 01/30/2006
• Published: 08/02/2007
• Est. Priority Date: 01/30/2006
• Status: Abandoned Application

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fowler, Brad, Balzer, Jeffrey, Sloan, Leif, Gliner, Bradford
• Application Number:
  US11/344,453
• Publication Number:
  US 20070179558A1
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods for varying electromagnetic and adjunctive neural therapies are disclosed. A method in accordance with one embodiment includes applying electromagnetic signals to a target neural population of a patient over a first period of time in accordance with a first mode (e.g., including signal delivery to the central nervous system or peripheral nervous system, via implanted or non-implanted devices). The method can further include applying electromagnetic stimulation to the patient over a second period of time in accordance with a second mode different than the first mode. Varying the mode between the first period of time and second period of time can increase the efficacy and/or longevity of the stimulation. Systems in accordance with other embodiments can support multiple signal delivery devices.

Claims

1. A method for treating a neural condition, comprising:

directing an application of electromagnetic signals to a target neural population of a patient over a first period of time in accordance with a first mode; and

directing an application of electromagnetic signals to the patient over a second period of time different than the first period of time in accordance with a second mode different than the first mode, wherein each of the first and second modes is selected from among the following modes;

(a) a CNS implant mode in which electromagnetic signals are applied to the patient'"'"'s central nervous system via at least one electrode implanted in the patient'"'"'s body;

(b) a CNS non-implant mode in which electromagnetic signals are applied to the patient'"'"'s central nervous system from a signal delivery device that is not implanted in the patient'"'"'s body;

(c) a peripheral implant mode in which electromagnetic signals are applied to the patient'"'"'s peripheral nervous system via at least one electrode implanted in the patient'"'"'s body; and

(d) a peripheral non-implant mode in which electromagnetic signals are applied to the patient'"'"'s peripheral nervous system from a signal delivery device that is not implanted in the patient'"'"'s body.

2. The method of claim 1 wherein directing an application of electromagnetic signals over at least one of the first and second time periods is performed at least in part by a practitioner.

3. The method of claim 1 wherein directing an application of electromagnetic signals over at least one of the first and second time periods is performed at least in part by a computer-readable medium.

4. The method of claim 1 wherein applying electromagnetic stimulation in accordance with the CNS implant mode includes applying electromagnetic stimulation from at least one electrode implanted within the patient'"'"'s skull.

5. The method of claim 1 wherein applying electromagnetic stimulation in accordance with the CNS non-implant mode includes applying electromagnetic stimulation from a location external to the patient'"'"'s skull.

6. The method of claim 1 wherein applying electromagnetic stimulation over the first period of time includes applying electromagnetic stimulation from a location proximate to the cerebral cortex and within the patient'"'"'s skull, and wherein applying electromagnetic stimulation over the second period of time includes applying transcranial direct current stimulation from a location external to the patient'"'"'s skull.

7. The method of claim 1 wherein applying electromagnetic stimulation over the first period of time includes improving a brain function of the patient, and wherein applying electromagnetic stimulation over the second period of time includes preserving, extending or both preserving and extending the improvement in brain function obtained during the first period of time.

8. The method of claim 1 wherein applying electromagnetic stimulation over one or both of the periods of time includes improving a brain function of the patient for a period of days, weeks, months or years.

9. The method of claim 1, further comprising applying a conditioning stimulus within minutes or hours before or after applying the electromagnetic stimulation during at least one of the first and second periods of time.

10. The method of claim 1 wherein:

directing an application of electromagnetic signals in accordance with a first mode includes directing electromagnetic signals with a first set of signal parameters, including at least one of;

a first current level, a first voltage level, a first pulse width, a first representative frequency, a first modulation function, and a first polarity; and

wherein

directing an application of electromagnetic signals in accordance with a second mode includes directing electromagnetic signals with a second set of signal parameters, including at least one of;

a second current level, a second voltage level, a second pulse width, a second representative frequency, a second modulation function, and a second polarity; and

wherein

at least one aspect of the second set of signal parameters is different than a corresponding aspect of the first set of signal parameters.

11. The method of claim 1, further comprising directing an application of signals in accordance with the first mode to a first location of the patient'"'"'s body, and directing an application of signals in accordance with the second mode to a second location of the patient'"'"'s body, different than the first.

12. The method of claim 11 wherein the first and second locations are selected from among the following locations:

a location at the cortex, a location above the cortex, a location below the cortex, a location at least proximate to the vagal nerve, a cerebellar location, a location at least proximate to a peripheral nerve, and a location at least proximate to a muscle.

13. The method of claim 11 wherein the first location is at least proximate to the patient'"'"'s cortex.

14. The method of claim 11 wherein the first and second locations are at the same hemisphere of the patient'"'"'s brain.

15. The method of claim 11 wherein the first and second locations are at different hemispheres of the patient'"'"'s brain.

16. The method of claim 11 wherein electromagnetic signals directed during the first time period are directed toward a first neural population and electromagnetic signals directed during the second time period are directed to a second neural population different than the first.

17. The method of claim 11 wherein electromagnetic signals applied during the first and second time periods are directed to the same neural populations.

18. The method of claim 1 wherein at least one of the first and second time periods has a duration of hours, days, or weeks.

19. The method of claim 1 wherein the first and second time periods are separated by a third time period having a duration of hours or days.

20. The method of claim 1 wherein the CNS non-implant mode includes transcranial magnetic stimulation.

21. The method of claim 1, further comprising treating the patient with a first adjunctive therapy during the first period of time and treating the patient with a second adjunctive therapy different than the first adjunctive therapy during the second period of time.

22. The method of claim 1 wherein directing an application of electromagnetic signals to the patient over a second period of time includes directing an application of electromagnetic signals to the patient after the patient'"'"'s rate of recovery has decreased.

23. The method of claim 1 wherein directing an application of electromagnetic signals to the patient over a second period of time includes directing an application of electromagnetic signals to the patient after a period of time during which the patient receives no electromagnetic signals.

24. The method of claim 1 wherein directing an application of electromagnetic signals in accordance with a first mode includes directing the application of electromagnetic signals in accordance with multiple first modes over the first period of time.

25. The method of claim 1 wherein directing an application of electromagnetic signals in accordance with a second mode includes directing the application of electromagnetic signals in accordance with multiple second modes over the second period of time.

26. The method of claim 1 wherein directing the application of electromagnetic signals over the first, second or both periods of time includes directing the application of electromagnetic signals in association a with behavioral therapy.

27. The method of claim 1 wherein directing the application of electromagnetic signals over the first, second or both periods of time includes directing the application of electromagnetic signals in association with an adjunctive therapy.

28. The method of claim 1 wherein directing an application of electromagnetic signals includes directing an application of electromagnetic signals at a level below a threshold level of the target neural population.

29. The method of claim 1 wherein directing an application of electromagnetic signals includes directing an application of electromagnetic signals at a level above a threshold level of the target neural population.

30. The method of claim 1 wherein directing an application of electromagnetic signals includes directing an application of first electromagnetic signals at a level below a threshold level of the target neural population and directing second electromagnetic signals at a level above a threshold level of the target neural population.

31. A method for treating a neural condition, comprising:

directing an application of electromagnetic signals to a target neural population of a patient at a subthreshold level over a first period of time in accordance with a first mode and in association with behavioral therapy; and

directing an application of electromagnetic signals to the patient at a subthreshold level over a second period of time different than the first period of time in accordance with a second mode different than the first mode and in association with behavioral therapy, wherein each of the first and second modes is selected from among the following modes;

(a) a CNS implant mode in which electromagnetic signals are applied to the patient'"'"'s central nervous system via at least one electrode implanted in the patient'"'"'s body;

(b) a CNS non-implant mode in which electromagnetic signals are applied to the patient'"'"'s central nervous system from a signal delivery device that is not implanted in the patient'"'"'s body;

(c) a peripheral implant mode in which electromagnetic signals are applied to at least one of the patient'"'"'s peripheral nervous system via at least one electrode implanted in the patient'"'"'s body; and

(d) a peripheral non-implant mode in which electromagnetic signals are applied to the patient'"'"'s peripheral nervous system from a signal delivery device that is not implanted in the patient'"'"'s body.

32. The method of claim 31 wherein the behavioral therapies during the first and second periods of time are different.

33. The method of claim 31 wherein the behavioral therapies during the first and second periods of time are the same.

34. A method for treating a neural condition, comprising:

directing an application of electromagnetic signals to a target neural population of a patient during a treatment regimen;

directing the patient to undergo a first adjunctive therapy for a first treatment period of weeks or months during the treatment regimen, the first adjunctive therapy being different than the electromagnetic signals; and

directing the patient to undergo a second adjunctive therapy for a second treatment period of weeks or months following the first period, wherein at least one characteristic of the second adjunctive therapy is different than the first adjunctive therapy and the electromagnetic signals.

35. The method of claim 34 wherein directing the patient to undergo a first adjunctive therapy includes directing the patient to undergo a first adjunctive therapy that is temporally proximate to the application of electromagnetic signals during the first treatment period.

36. The method of claim 34 wherein the electromagnetic signals include first electromagnetic signals that are provided directly to the cortex of the patient from a location within the patient'"'"'s skull, and that are provided in conjunction with a first adjunctive therapy that includes systematized, directed physical activity, and wherein the method further comprises providing second electromagnetic signals temporally proximate to the second adjunctive therapy, further wherein the second electromagnetic signals are provided directly to the cortex of the patient from a location within the patient'"'"'s skull, and wherein the second adjunctive therapy includes activities of daily living.

37. The method of claim 34 wherein applying the electromagnetic signals includes providing the electromagnetic signals temporally proximate to at least one of the adjunctive therapies and wherein applying the electromagnetic signals includes applying the electromagnetic signals via transcranial direct current stimulation.

38. The method of claim 34 wherein applying the electromagnetic signals includes providing the electromagnetic signals temporally proximate to at least one of the adjunctive therapies and wherein applying the electromagnetic signals includes applying the electromagnetic signals to the patient'"'"'s vagal nerve.

39. The method of claim 34 wherein the adjunctive therapy for each of the first and second treatment periods includes at least one of the following activities:

drug intake, activities of daily living, and systematized, directed physical activity, wherein the systematized, directed physical activity includes one or more of a visual, auditory, language-based, gustatory, olfactory and haptic activity.

40. The method of claim 39 wherein at least one of the first and second treatment periods includes an activity not included in the other treatment period.

41. The method of claim 39 wherein a characteristic of an activity conducted during the first treatment period is different during the second treatment period.

42. The method of claim 34 wherein the adjunctive therapy is a behavioral therapy.

43. A method for treating a neural condition, comprising:

directing an application of first electromagnetic signals to a first target neural population of a patient, the first target neural population being a cortical neural population; and

directing an application of second electromagnetic signals to a second target neural population of the patient, the second target neural population being a sub-cortical neural population.

44. The method of claim 43 wherein directing an application of the first electromagnetic signals to a first target neural population includes directing an application of the first electromagnetic signals to the cerebral cortex.

45. The method of claim 43 wherein directing an application of the first electromagnetic signals to a first target neural population includes directing an application of the first electromagnetic signals to the cerebellar cortex.

46. The method of claim 43 wherein directing an application of the first electromagnetic signals is at least approximately simultaneous with directing an application of the second electromagnetic signals.

47. The method of claim 43 wherein directing an application of the first and second electromagnetic signals includes directing the application of the first and second electromagnetic signals in the same treatment session.

48. The method of claim 43 wherein directing an application of the first electromagnetic signals includes facilitating the patient'"'"'s cognitive functioning, and wherein directing the application of the second electromagnetic signals includes facilitating the patient'"'"'s non-cognitive functioning.

49. The method of claim 43 wherein directing an application of electromagnetic signals to the first and second target neural populations includes directing an application of electromagnetic signals to target neural populations that share a neurological signal path.

50. The method of claim 43 wherein directing an application of second electromagnetic signals is sequential to directing application of first electromagnetic signals.

51. A method for treating a neural condition, comprising:

directing an application of first electromagnetic signals to a first target neural population of a patient, the first target neural population being a cortical population; and

directing an application of second electromagnetic signals to a second target neural population of the patient, the second target neural population being a vagal population.

52. The method of claim 51 wherein directing an application of the first electromagnetic signals to a first target neural population includes directing an application of the first electromagnetic signals to the cerebral cortex.

53. The method of claim 51 wherein directing an application of the first electromagnetic signals is at least approximately simultaneous with directing an application of the second electromagnetic signals.

54. The method of claim 51 wherein directing an application of the first and second electromagnetic signals includes directing the application of the first and second electromagnetic signals in the same treatment session.

55. The method of claim 51 wherein directing an application of the first electromagnetic signals includes facilitating the patient'"'"'s cognitive functioning, and wherein directing the application of the second electromagnetic signals includes facilitating the patient'"'"'s non-cognitive functioning.

56. The method of claim 51 wherein directing an application of electromagnetic signals to the first and second target neural populations includes directing an application of electromagnetic signals to target neural populations that share a neurological signal pathway.

57. The method of claim 51 wherein directing an application of second electromagnetic signals is sequential to directing application of first electromagnetic signals.

58. A method for treating a neural condition, comprising:

directing an application of first electromagnetic signals to a first target neural population of a patient, the first target neural population being a cortical population; and

directing an application of second electromagnetic signals to a second target neural population of the patient, the second target neural population being a spinal cord population.

59. The method of claim 58 wherein directing an application of the first electromagnetic signals to a first target neural population includes directing an application of the first electromagnetic signals to the cerebral cortex.

60. The method of claim 58 wherein directing an application of the first electromagnetic signals to a first target neural population includes directing an application of the first electromagnetic signals to the cerebellar cortex.

61. The method of claim 58 wherein directing an application of the first electromagnetic signals is at least approximately simultaneous with directing an application of the second electromagnetic signals.

62. The method of claim 58 wherein directing an application of the first and second electromagnetic signals includes directing the application of the first and second electromagnetic signals in the same treatment session.

63. The method of claim 58 wherein directing an application of the first electromagnetic signals includes facilitating the patient'"'"'s cognitive functioning, and wherein directing the application of the second electromagnetic signals includes facilitating the patient'"'"'s non-cognitive functioning.

64. The method of claim 58 wherein directing an application of electromagnetic signals to the first and second target neural populations includes directing an application of electromagnetic signals to target neural populations that share a neurological signal pathway.

65. The method of claim 58 wherein directing an application of the second electromagnetic signals is sequential to directing an application of the first electromagnetic signals.

66. A method for treating a neural condition, comprising:

during a first portion of a patient'"'"'s treatment regimen, directly supervising (a) application of first electromagnetic signals to a target neural population of the patient, (b) the patient'"'"'s performance of a first adjunctive therapy, or (c) both (a) and (b); and

instructing the patient to undergo a second portion of the treatment regimen without directly supervising (d) application of second electromagnetic signals to a target neural population of the patient, (e) the patient'"'"'s performance of a second adjunctive therapy, or (f) both (d) and (e), wherein a characteristic of the electromagnetic signals, the adjunctive therapies, or both is different during the first portion than it is during the second portion.

67. The method of claim 66 wherein the first electromagnetic signals are applied in accordance with a first mode, and wherein the second electromagnetic signals are applied in accordance with a second mode different than the first mode.

68. The method of claim 67 wherein the first electromagnetic signals are applied in accordance with a non-implant mode, and wherein the second electromagnetic signals are applied in accordance with an implant mode.

69. The method of claim 67 wherein the first electromagnetic signals are applied via transcranial magnetic stimulation or direct current stimulation, and wherein the second electromagnetic signals are applied to the cortex via at least one implanted electrode.

70. The method of claim 66 wherein the second electromagnetic signals are triggered automatically when the patient engages in the second adjunctive therapy.

71. The method of claim 66 wherein the target neural population is the same during the first and second portions of the treatment regimen.

72. The method of claim 66 wherein the target neural population during the first portion of the treatment regimen is different than the target neural population during the second portion of the treatment regimen.

73. A system for controlling electromagnetic signals applied to a patient, comprising:

a controller coupleable to a first patient signal delivery device having a first configuration and a second patient signal delivery device having a second configuration different than the first, the controller being configured to direct electromagnetic signals to a patient via the first and second signal delivery devices, the controller having a first selectable control mode when coupled to the first patient signal delivery device, and a second selectable control mode when coupled to the second patient signal delivery device, wherein;

when the controller is coupled to the first patient signal delivery device, the controller automatically directs first signals in the first control mode; and

when the controller is coupled to the second patient signal delivery device, the controller automatically directs second signals in the second control mode.

74. The system of claim 73 wherein at least one characteristic of the second signals is different than a corresponding characteristic of the first signals.

75. The system of claim 73 wherein at least one characteristic of the second control mode is different than a corresponding characteristic of the first control mode.

76. The system of claim 73 wherein the controller includes at least one of an implantable unit and a unit configured to be positioned external to the patient.

77. The system of claim 73 wherein:

the controller is configured to prevent delivery of electromagnetic signals corresponding to the second mode when the controller is in the first mode; and

the controller is configured to prevent delivery of electromagnetic signals corresponding to the first mode when the controller is in the second mode.

78. The system of claim 73 wherein the controller includes at least one of a hardware device and a computer readable medium programmed with instructions to prevent delivery of electromagnetic signals corresponding to the second mode when the controller is coupled to the first patient signal delivery device, and prevent delivery of electromagnetic signals corresponding to the first mode when the controller is coupled to the second patient signal delivery device.

79. The system of claim 73 wherein:

the first control mode is associated with a first set of signal delivery parameters, including at least one of;

a first current level, a first voltage level, a first pulse width, a first representative frequency, a first modulation function, and a first polarity;

the second control mode is associated with a second set of signal delivery parameters that includes at least one of;

a second current level, a second voltage level, a second pulse width, a second representative frequency, a second modulation function, and a second polarity; and

at least one aspect of the second set of signal delivery parameters is different than a corresponding aspect of the first set of signal delivery parameters.

80. The system of claim 73, further comprising the first and second patient signal delivery devices.

81. The system of claim 80 wherein the first patient signal delivery device is configured to provide one of cortical electrical stimulation, deep brain electrical stimulation, vagal stimulation, trans-cranial direct current stimulation and transcranial magnetic stimulation, and wherein the second patient signal delivery device is configured to provide another of cortical electrical stimulation, deep brain electrical stimulation, vagal stimulation trans-cranial direct current stimulation and transcranial magnetic stimulation.

82. The system of claim 73 wherein the first patient signal delivery device includes an electrode configured to be positioned proximate to a cortical surface within a patient'"'"'s skull, and wherein the second patient signal delivery device includes an electrode configured to be positioned at least proximate to the vagal nerve.

83. The system of claim 73 wherein the first patient signal delivery device includes an electrode configured to be positioned proximate to a cortical surface within a patient'"'"'s skull, and wherein the second patient signal delivery device includes a transcranial direct current stimulator.