Non-invasive neuromodulation (NINM) for rehabilitation of brain function

• US 9,597,504 B1
• Filed: 07/31/2015
• Issued: 03/21/2017
• Est. Priority Date: 01/04/2008
• Status: Active Grant

• Current Assignee: Neurohabilitation Corporation (Helius Medical Technologies, Inc.)
• Original Assignee: Neurohabilitation Corporation (Helius Medical Technologies, Inc.)
• Inventors: Danilov, Yuri P., Tyler, Mitchell E., Kaczmarek, Kurt A.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/815,171
• Time in Patent Office: 599 Days
• Field of Search: 607/134
• US Class Current: 1/1
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36092 Mental training
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26

Abstract

In a patient suffering from neural impairment, stimulation is provided to sensory surfaces of the face and/or neck, or more generally to areas of the body that stimulate the trigeminal nerve, while performing an activity intended to stimulate a brain function to be rehabilitated. The simulation may then be continued after the performance of the activity has ceased. It has been found that the patient'"'"'s performance of the activity is then improved after stimulation has ceased. Moreover, it tends to improve to a greater extent, and/or for a longer time, when the post-activity stimulation is applied, as compared to when postactivity stimulation is not applied.

Claims

1. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging a patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by impairment of the patient'"'"'s nervous system;

providing intraoral cutaneous stimulation of at least one of the patient'"'"'s trigeminal nerve or the patient'"'"'s facial nerve via a mouthpiece situated within the patient'"'"'s mouth, the mouthpiece having an array of one or more electrodes disposed on at least one surface of the mouthpiece; and

delivering electrical pulses from a pulse generator to the patient'"'"'s tongue via the mouthpiece, the delivery of electrical pulses being contemporaneous with the patient'"'"'s engagement in the exercise and independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the exercise.

2. The method of claim 1 wherein the electrodes have a circular cross section and have a diameter that is in a range of 1-10 mm.

3. The method of claim 2 wherein the electrodes are composed of at least one of gold, titanium, platinum, rhodium, stainless steel.

4. The method of claim 3 wherein the electrodes are insulating electrodes that include at least one of silicon oxide, titanium oxide, strontium oxide, or tin oxide.

5. The method of claim 4 further comprising delivering a capacitive displacement current through the mouthpiece, the capacitive displacement current flowing into the patient'"'"'s tongue.

6. The method of claim 4 further comprising providing an electrically conductive material between the electrodes and the patient'"'"'s tongue.

7. The method of claim 6 wherein the electrically conductive material is a conductive polymer.

8. The method of claim 1 further comprising delivering a first group of electrical pulses having a first frequency to a first group of electrodes on the mouthpiece and delivering a second group of electrical pulses having a second frequency to a second group of electrodes on the mouthpiece.

9. The method of claim 1 further comprising engaging the patient in one or more of the following:

a brain training exercise, a computerized brain training exercise, a memory recollection exercise, an attention span increasing exercise, or a reading comprehension exercise.

10. The method of claim 1 wherein the engaging step further comprises (i) having the patient perform the exercise at high intensity and (ii) subsequently having the patient perform the exercise at moderate intensity, while simultaneously providing the intraoral cutaneous stimulation to the patient'"'"'s tongue.

11. The method of claim 1 wherein the engaging step further comprises having the patient perform the exercise at low intensity before performing the exercise at high intensity.

12. The method of claim 1 further comprising providing the intraoral cutaneous stimulation during one or more of a period shortly or immediately after the patient has engaged in the exercise or a period shortly or immediately prior to having the patient engage in the exercise, without taking measurements of electrical activity of the patient'"'"'s brain during the one or more periods.

13. The method of claim 1 further comprising delivering the electrical pulses at an intensity level beneath the patient'"'"'s threshold of sensory perception.

14. The method of claim 1 further comprising delivering electrical pulses to the patient'"'"'s tongue in a random or repeating pattern that is independent of events occurring outside of the pulse generator and the mouthpiece.

15. The method of claim 1 further comprising engaging the patient in a cognitive exercise that includes delivery of queries to the patient via a computer, and requires the patient to supply responses to the computer.

16. The method of claim 1 further comprising engaging the patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by one of traumatic brain injury, stroke, Parkinson'"'"'s disease, multiple sclerosis, or Alzheimer'"'"'s disease.

17. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency of about 40 Hz and the patient'"'"'s ability to perform the exercise is hindered by sensory dysfunction.

18. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 30-50 Hz and the patient'"'"'s ability to perform the exercise is hindered by Parkinson'"'"'s disease.

19. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 1-40 Hz and the patient'"'"'s ability to perform the exercise is hindered by involuntary movement or involuntary tremor.

20. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency is about 150 Hz and the patient'"'"'s ability to perform the exercise is hindered by bradykinesia.

21. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue have a voltage in a range of 1-40 volts and deliver a current to the patient'"'"'s tongue of about 0.5-50 mA.

22. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

23. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

24. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue are delivered in groups, with each group having between 1 and 100 pulses and the groups being delivered at a rate in a range of 1-100 Hz.

25. The method of claim 1 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 25 and 50 microseconds in duration and have a frequency of about 200 Hz.

26. The method of claim 1 wherein the mouthpiece is configured to be worn by a patient.

27. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging a patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by impairment of the patient'"'"'s nervous system;

providing intraoral cutaneous stimulation of at least one of the patient'"'"'s trigeminal nerve or the patient'"'"'s facial nerve via a mouthpiece situated within the patient'"'"'s mouth, the mouthpiece having an array of one or more electrodes located on at least one surface of the mouthpiece; and

delivering electrical pulses from a signal generator to the patient'"'"'s intraoral cavity via the mouthpiece, the delivery of electrical pulses being contemporaneous with the patient'"'"'s engagement in the exercise and independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the exercise.

28. The method of claim 27 wherein the electrodes have a circular cross section and have a diameter that is in a range of 1-10 mm.

29. The method of claim 28 wherein the electrodes are composed of at least one of gold, titanium, platinum, rhodium, stainless steel.

30. The method of claim 29 wherein the electrodes are insulating electrodes that include at least one of silicon oxide, titanium oxide, strontium oxide, or tin oxide.

31. The method of claim 30 further comprising delivering a capacitive displacement current through the mouthpiece, the capacitive displacement current flowing into the patient'"'"'s intraoral cavity.

32. The method of claim 30 further comprising providing an electrically conductive material between the electrodes and the patient'"'"'s intraoral cavity.

33. The method of claim 32 wherein the electrically conductive material is a conductive polymer.

34. The method of claim 27 further comprising delivering a first group of electrical pulses having a first frequency to a first group of electrodes on the mouthpiece and delivering a second group of electrical pulses having a second frequency to a second group of electrodes on the mouthpiece.

35. The method of claim 27 further comprising engaging the patient in one or more of the following:

a brain training exercise, a computerized brain training exercise, a memory recollection exercise, an attention span increasing exercise, or a reading comprehension exercise.

36. The method of claim 27 wherein the engaging step further comprises (i) having the patient perform the exercise at high intensity and (ii) subsequently having the patient perform the exercise at moderate intensity, while simultaneously providing the intraoral cutaneous stimulation to the patient'"'"'s intraoral cavity.

37. The method of claim 27 wherein the engaging step further comprises having the patient perform the exercise at low intensity before performing the exercise at high intensity.

38. The method of claim 27 further comprising providing the intraoral cutaneous stimulation during one or more of a period shortly or immediately after the patient has engaged in the exercise or a period shortly or immediately prior to having the patient engage in the exercise, without taking measurements of electrical activity of the patient'"'"'s brain during the one or more periods.

39. The method of claim 27 further comprising delivering the electrical pulses at an intensity level beneath the patient'"'"'s threshold of sensory perception.

40. The method of claim 27 further comprising delivering electrical pulses to the patient'"'"'s intraoral cavity in a random or repeating pattern that is independent of events occurring outside of the signal generator and the mouthpiece.

41. The method of claim 27 further comprising engaging the patient in a cognitive exercise that includes delivery of queries to the patient via a computer, and requires the patient to supply responses to the computer.

42. The method of claim 27 further comprising engaging the patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by one of traumatic brain injury, stroke, Parkinson'"'"'s disease, multiple sclerosis, or Alzheimer'"'"'s disease.

43. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity have a fundamental frequency of about 40 Hz and the patient'"'"'s ability to perform the exercise is hindered by sensory dysfunction.

44. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity have a fundamental frequency in a range of 30-50 Hz and the patient'"'"'s ability to perform the exercise is hindered by Parkinson'"'"'s disease.

45. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity have a fundamental frequency in a range of 1-40 Hz and the patient'"'"'s ability to perform the exercise is hindered by involuntary movement or involuntary tremor.

46. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity have a fundamental frequency is about 150 Hz and the patient'"'"'s ability to perform the exercise is hindered by bradykinesia.

47. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity have a voltage in a range of 1-40 volts and deliver a current to the patient'"'"'s intraoral cavity of about 0.5-50 mA.

48. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

49. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

50. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity are delivered in groups, with each group having between 1 and 100 pulses and the groups being delivered at a rate in a range of 1-100 Hz.

51. The method of claim 27 wherein the electrical pulses delivered to the patient'"'"'s intraoral cavity are between 25 and 50 microseconds in duration and have a frequency of about 200 Hz.

52. The method of claim 27 wherein the mouthpiece is configured to be worn by a patient.

53. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging a patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by impairment of the patient'"'"'s nervous system;

providing intraoral cutaneous stimulation of at least one of the patient'"'"'s trigeminal nerve or the patient'"'"'s facial nerve via an electrode array of one or more electrodes situated within the patient'"'"'s mouth; and

delivering electrical pulses from a pulse generator to the patient'"'"'s tongue via the electrode array, the delivery of electrical pulses being contemporaneous with the patient'"'"'s engagement in the exercise and independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the exercise.

54. The method of claim 53 wherein the electrodes have a circular cross section and have a diameter that is in a range of 1-10 mm.

55. The method of claim 54 wherein the electrodes are composed of at least one of gold, titanium, platinum, rhodium, stainless steel.

56. The method of claim 55 wherein the electrodes are insulating electrodes that include at least one of silicon oxide, titanium oxide, strontium oxide, or tin oxide.

57. The method of claim 56 further comprising delivering a capacitive displacement current through the electrode array, the capacitive displacement current flowing into the patient'"'"'s tongue.

58. The method of claim 56 further comprising providing an electrically conductive material between the electrodes and the patient'"'"'s tongue.

59. The method of claim 58 wherein the electrically conductive material is a conductive polymer.

60. The method of claim 53 further comprising delivering a first group of electrical pulses having a first frequency to a first group of electrodes on the electrode array and delivering a second group of electrical pulses having a second frequency to a second group of electrodes on the electrode array.

61. The method of claim 53 further comprising engaging the patient in one or more of the following:

a brain training exercise, a computerized brain training exercise, a memory recollection exercise, an attention span increasing exercise, or a reading comprehension exercise.

62. The method of claim 53 wherein the engaging step further comprises (i) having the patient perform the exercise at high intensity and (ii) subsequently having the patient perform the exercise at moderate intensity, while simultaneously providing the intraoral cutaneous stimulation to the patient'"'"'s tongue.

63. The method of claim 53 wherein the engaging step further comprises having the patient perform the exercise at low intensity before performing the exercise at high intensity.

64. The method of claim 53 further comprising providing the intraoral cutaneous stimulation during one or more of a period shortly or immediately after the patient has engaged in the exercise or a period shortly or immediately prior to having the patient engage in the exercise, without taking measurements of electrical activity of the patient'"'"'s brain during the one or more periods.

65. The method of claim 53 further comprising delivering the electrical pulses at an intensity level beneath the patient'"'"'s threshold of sensory perception.

66. The method of claim 53 further comprising delivering electrical pulses to the patient'"'"'s tongue in a random or repeating pattern that is independent of events occurring outside of the pulse generator and the electrode array.

67. The method of claim 53 further comprising engaging the patient in a cognitive exercise that includes delivery of queries to the patient via a computer, and requires the patient to supply responses to the computer.

68. The method of claim 53 further comprising engaging the patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by one of traumatic brain injury, stroke, Parkinson'"'"'s disease, multiple sclerosis, or Alzheimer'"'"'s disease.

69. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency of about 40 Hz and the patient'"'"'s ability to perform the exercise is hindered by sensory dysfunction.

70. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 30-50 Hz and the patient'"'"'s ability to perform the exercise is hindered by Parkinson'"'"'s disease.

71. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 1-40 Hz and the patient'"'"'s ability to perform the exercise is hindered by involuntary movement or involuntary tremor.

72. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency is about 150 Hz and the patient'"'"'s ability to perform the exercise is hindered by bradykinesia.

73. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue have a voltage in a range of 1-40 volts and deliver a current to the patient'"'"'s tongue of about 0.5-50 mA.

74. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

75. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

76. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue are delivered in groups, with each group having between 1 and 100 pulses and the groups being delivered at a rate in a range of 1-100 Hz.

77. The method of claim 53 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 25 and 50 microseconds in duration and have a frequency of about 200 Hz.

78. The method of claim 53 wherein the electrode array is configured to be worn by a patient.

79. A method for non-invasively assisting neurorehabilitation in a patient comprising:

engaging a patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by impairment of the patient'"'"'s nervous system;

providing intraoral cutaneous stimulation of at least one of the patient'"'"'s trigeminal nerve or the patient'"'"'s facial nerve via an electrode array of one or more electrodes situated within the patient'"'"'s mouth; and

delivering electrical pulses from a signal generator to the patient'"'"'s tongue via the electrode array, the delivery of electrical pulses being contemporaneous with the patient'"'"'s engagement in the exercise and independent of the patient'"'"'s surrounding environment and the patient'"'"'s engagement in the exercise.

80. The method of claim 79 wherein the electrodes have a circular cross section and have a diameter that is in a range of 1-10 mm.

81. The method of claim 80 wherein the electrodes are composed of at least one of gold, titanium, platinum, rhodium, stainless steel.

82. The method of claim 81 wherein the electrodes are insulating electrodes that include at least one of silicon oxide, titanium oxide, strontium oxide, or tin oxide.

83. The method of claim 82 further comprising delivering a capacitive displacement current through the electrode array, the capacitive displacement current flowing into the patient'"'"'s tongue.

84. The method of claim 82 further comprising providing an electrically conductive material between the electrodes and the patient'"'"'s tongue.

85. The method of claim 84 wherein the electrically conductive material is a conductive polymer.

86. The method of claim 79 further comprising delivering a first group of electrical pulses having a first frequency to a first group of electrodes on the electrode array and delivering a second group of electrical pulses having a second frequency to a second group of electrodes on the electrode array.

87. The method of claim 79 further comprising engaging the patient in one or more of the following:

a brain training exercise, a computerized brain training exercise, a memory recollection exercise, an attention span increasing exercise, or a reading comprehension exercise.

88. The method of claim 79 wherein the engaging step further comprises (i) having the patient perform the exercise at high intensity and (ii) subsequently having the patient perform the exercise at moderate intensity, while simultaneously providing the intraoral cutaneous stimulation to the patient'"'"'s tongue.

89. The method of claim 79 wherein the engaging step further comprises having the patient perform the exercise at low intensity before performing the exercise at high intensity.

90. The method of claim 79 further comprising providing the intraoral cutaneous stimulation during one or more of a period shortly or immediately after the patient has engaged in the exercise or a period shortly or immediately prior to having the patient engage in the exercise, without taking measurements of electrical activity of the patient'"'"'s brain during the one or more periods.

91. The method of claim 79 further comprising delivering the electrical pulses at an intensity level beneath the patient'"'"'s threshold of sensory perception.

92. The method of claim 79 further comprising delivering electrical pulses to the patient'"'"'s tongue in a random or repeating pattern that is independent of events occurring outside of the signal generator and the electrode array.

93. The method of claim 79 further comprising engaging the patient in a cognitive exercise that includes delivery of queries to the patient via a computer, and requires the patient to supply responses to the computer.

94. The method of claim 79 further comprising engaging the patient in an exercise wherein the patient'"'"'s ability to perform the exercise is hindered by one of traumatic brain injury, stroke, Parkinson'"'"'s disease, multiple sclerosis, or Alzheimer'"'"'s disease.

95. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency of about 40 Hz and the patient'"'"'s ability to perform the exercise is hindered by sensory dysfunction.

96. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 30-50 Hz and the patient'"'"'s ability to perform the exercise is hindered by Parkinson'"'"'s disease.

97. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency in a range of 1-40 Hz and the patient'"'"'s ability to perform the exercise is hindered by involuntary movement or involuntary tremor.

98. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue have a fundamental frequency is about 150 Hz and the patient'"'"'s ability to perform the exercise is hindered by bradykinesia.

99. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue have a voltage in a range of 1-40 volts and deliver a current to the patient'"'"'s tongue of about 0.5-50 mA.

100. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

101. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 1 and 500 microseconds in duration and have a frequency in a range of 1-1000 Hz.

102. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue are delivered in groups, with each group having between 1 and 100 pulses and the groups being delivered at a rate in a range of 1-100 Hz.

103. The method of claim 79 wherein the electrical pulses delivered to the patient'"'"'s tongue are between 25 and 50 microseconds in duration and have a frequency of about 200 Hz.

104. The method of claim 79 wherein the electrode array is configured to be worn by a patient.