Systems, methods and devices for treating tinnitus

• US 8,934,967 B2
• Filed: 06/16/2009
• Issued: 01/13/2015
• Est. Priority Date: 07/02/2008
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Kilgard, Michael, Cauller, Larry, Engineer, Navzer, McIntyre, Christa, Rosellini, Will
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US12/485,860
• Publication Number:
  US 20100004705A1
• Time in Patent Office: 2,037 Days
• Field of Search: 607/33, 607/35, 607/57, 607/116, 607/136, 607/137
• US Class Current: 607/2
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61M 2021/0016 by the smell sense
• CPC Class Codes: A61M 2021/0022 by the tactile sense, e.g. vibrations
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 2021/0044 by the sight sense
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 2021/0077 with application of chemical or pharmacological stimulus
• CPC Class Codes: A61M 21/00 Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61M 2205/3515 using magnetic means
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36053 : adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36067 : Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• 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 1/361 : 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: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/36167 : Timing, e.g. stimulation onset
• CPC Class Codes: A61N 5/0618 : Psychological treatment
• CPC Class Codes: A61N 5/0622 : Optical stimulation for exciting neural tissue
• 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
• CPC Class Codes: G09B 19/003 : Repetitive work cycles; Sequence of movements
• CPC Class Codes: G09B 23/28 : for medicine
• CPC Class Codes: H04R 25/75 : Electric tinnitus maskers providing an auditory perception

Abstract

Systems, methods and devices for paired training include timing controls so that training and neural stimulation can be provided simultaneously. Paired trainings may include therapies, rehabilitation and performance enhancement training. Stimulations of nerves such as the vagus nerve that affect subcortical regions such as the nucleus basalis, locus coeruleus or amygdala induce plasticity in the brain, enhancing the effects of a variety of therapies, such as those used to treat tinnitus, stroke, traumatic brain injury and post-traumatic stress disorder.

Claims

1. A method of treating tinnitus in a patient, comprising:

measuring a patient'"'"'s tinnitus symptoms;

selecting therapeutic sounds based on the measured tinnitus symptoms, wherein each therapeutic sound consists of only one frequency, and wherein the frequency is audible to the patient;

providing a repeated paired training therapy by providing a series of the therapeutic sounds paired with a vagus nerve stimulation pulse train by presenting the vagus nerve stimulation pulse train during presentation of the therapeutic sounds, wherein the vagus nerve stimulation pulse train is generated by a subcutaneous device that provides electrical stimulation of the patient'"'"'s vagus nerve;

repeatedly presenting the series of paired therapeutic sounds; and

reducing the patient'"'"'s perception of tinnitus.

2. The method of claim 1, wherein the frequency is outside of one or more tinnitus frequencies characterizing the patient'"'"'s tinnitus symptoms.

3. The method of claim 2, wherein the vagus nerve stimulation pulse train lasts 500 milliseconds and comprises 15 pulses 100 microseconds long, and wherein the vagus nerve stimulation occurs at 30 Hertz, has a current amplitude of 0.8 milliamps, and starts 150 milliseconds after the therapeutic sound.

4. The method of claim 2, wherein the vagus nerve stimulation pulse train starts within 15 seconds of the presentation of the therapeutic tone.

5. The method of claim 4, wherein the frequency for each paired training therapy is identical.

6. The method of claim 4, wherein the frequency for each paired training therapy is unique with respect to each other.

7. The method of claim 1, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

8. The method of claim 1, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

9. The method of claim 1, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

10. The method of claim 1, wherein the paired therapeutic sounds are repeated 300 times.

11. The method of claim 1, wherein the paired therapeutic sounds are repeated 300 times per day for twenty days.

12. The method of claim 1, wherein the paired therapeutic sounds are repeated 300 times in 150 minutes.

13. The method of claim 1, wherein the presentation of paired therapeutic sounds is random.

14. The method of claim 1, wherein the therapeutic sounds are tones.

15. The method of claim 1, wherein the paired training therapy generates manifestations of plasticity in a brain of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the generated manifestations of plasticity.

16. A method of treating tinnitus in a patient, comprising:

assessing a patient'"'"'s tinnitus symptoms;

selecting a therapeutic sound based on the assessed tinnitus symptoms, wherein the therapeutic sound consists of only one frequency, and wherein the frequency is audible to the patient;

pairing the therapeutic sound with a vagus nerve stimulation pulse train originating from a device that provides electrical stimulation to the vagus nerve by presenting the vagus nerve stimulation pulse train during presentation of the therapeutic sound;

repeating the step of selecting a therapeutic sound;

repeating the step of pairing the therapeutic sound; and

reducing the patient'"'"'s perception of tinnitus.

17. The method of claim 16, wherein the frequency is outside of one or more tinnitus frequencies characterizing the patient'"'"'s tinnitus symptoms.

18. The method of claim 16, wherein presentation of the therapeutic sound is 500 milliseconds.

19. The method of claim 16, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

20. The method of claim 16, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

21. The method of claim 16, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

22. The method of claim 16, wherein the paired therapeutic sound is repeated 300 times.

23. The method of claim 16, wherein the paired therapeutic sound is repeated 300 times per day for twenty days.

24. The method of claim 16, wherein the paired therapeutic sound is repeated 300 times in 150 minutes.

25. The method of claim 16, wherein the therapeutic sound is a tone.

26. The method of claim 16, wherein the device is a subcutaneous device that provides electrical stimulation of the patient'"'"'s vagus nerve.

27. The method of claim 16, wherein the paired therapeutic sound with the vagus nerve stimulation pulse train generates manifestations of plasticity in a brain of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the generated manifestations of plasticity.

28. A method of treating tinnitus in a subject, comprising:

assessing a subject'"'"'s tinnitus symptoms;

selecting a plurality of therapeutic sounds based on the assessed tinnitus symptoms, wherein each therapeutic sound consists of only one frequency;

repeatedly presenting a plurality of paired therapeutic sounds where one of the therapeutic sounds is paired by presenting a vagus nerve stimulation pulse train during presentation of the one therapeutic sound, wherein the vagus nerve stimulation pulse train is generated by a subcutaneous device that provides electrical stimulation of the subject'"'"'s vagus nerve; and

reducing the subject'"'"'s perception of tinnitus.

29. The method of claim 28, wherein presentation of the therapeutic sounds are 500 milliseconds.

30. The method of claim 28, wherein the frequency is outside of tinnitus frequencies characterizing the subject'"'"'s tinnitus symptoms, and wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

31. The method of claim 28, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

32. The method of claim 28, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

33. The method of claim 28, wherein the paired therapeutic sounds are repeated 300 times.

34. The method of claim 28, wherein the paired therapeutic sounds are repeated 300 times per day for twenty days.

35. The method of claim 28, wherein the paired therapeutic sounds are repeated 300 times in 150 minutes.

36. The method of claim 28, wherein the presentation of paired therapeutic sounds is random.

37. The method of claim 28, wherein the therapeutic sounds are tones.

38. The method of claim 28, wherein the paired therapeutic sound with the vagus nerve stimulation pulse train generates manifestations of plasticity in a brain of the subject, and wherein the reduction of the subject'"'"'s perception of tinnitus is due to the generated manifestations of plasticity.

39. A method of treating tinnitus in a subject, comprising:

assessing a subject'"'"'s tinnitus symptoms;

selecting a plurality of therapeutic sounds based on the assessed tinnitus symptoms, wherein each therapeutic sound consists of only one frequency;

pairing the therapeutic sounds with a plurality of vagus nerve stimulation pulse trains originating from a device that provides electrical stimulation to the vagus nerve by presenting one of the vagus nerve stimulation pulse trains during presentation of one of the therapeutic sounds;

repeatedly presenting the paired therapeutic sounds; and

reducing the subject'"'"'s perception of tinnitus.

40. The method of claim 39, wherein presentation of each therapeutic sound is 500 milliseconds.

41. The method of claim 39, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

42. The method of claim 39, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

43. The method of claim 39, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

44. The method of claim 39, wherein the paired therapeutic sounds are repeated 300 times.

45. The method of claim 39, wherein the paired therapeutic sounds are repeated 300 times per day for twenty days.

46. The method of claim 39, wherein the paired therapeutic sounds are repeated 300 times in 150 minutes.

47. The method of claim 39, wherein the presentation of paired therapeutic sounds is random.

48. The method of claim 39, wherein the therapeutic sounds are tones, wherein the device is a subcutaneous device that provides electrical stimulation of the subject'"'"'s vagus nerve.

49. The method of claim 39, wherein the paired therapeutic sounds with the vagus nerve stimulation pulse trains results in a plasticity based remapping of an auditory cortex of the subject, and wherein the reduction of the subject'"'"'s perception of tinnitus is due to the remapping.

50. A method of treating tinnitus in a patient, comprising:

determining a patient'"'"'s tinnitus symptoms;

selecting therapeutic sounds based on the determined tinnitus symptoms, wherein each therapeutic sound consists of only one frequency;

pairing a plurality of therapeutic sounds with a plurality of vagus nerve stimulation pulse trains originating from a device that provides electrical stimulation to the vagus nerve by presenting one of the vagus nerve stimulation pulse trains during presentation of one of the therapeutic sounds;

repeatedly presenting the plurality of paired therapeutic sounds; and

reducing the patient'"'"'s perception of tinnitus.

51. The method of claim 50, wherein presentation of each therapeutic sound is 500 milliseconds.

52. The method of claim 50, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

53. The method of claim 50, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

54. The method of claim 50, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

55. The method of claim 50, wherein the paired therapeutic sounds are repeated 300 times.

56. The method of claim 50, wherein the paired therapeutic sounds are repeated 300 times per day for twenty days.

57. The method of claim 50, wherein the paired therapeutic sounds are repeated 300 times in 150 minutes.

58. The method of claim 50, wherein the presentation of paired therapeutic sounds is random.

59. The method of claim 50, wherein the therapeutic sounds are tones, wherein the device is a subcutaneous device that provides electrical stimulation of the patient'"'"'s vagus nerve, wherein each therapeutic sound consists of only one frequency.

60. The method of claim 50, wherein the paired plurality of therapeutic sounds with the plurality of vagus nerve stimulation pulse trains results in a plasticity based remapping of an auditory cortex of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the remapping.

61. A method of treating tinnitus in a subject, comprising:

determining a subject'"'"'s tinnitus symptoms;

selecting therapeutic sounds based on the determined tinnitus symptoms, wherein each therapeutic sound consists of only one frequency, wherein the frequencies are audible to the subject, and wherein the frequencies are outside of one or more tinnitus frequencies characterizing the subject'"'"'s tinnitus symptoms;

presenting the therapeutic sounds paired with vagus nerve stimulation by presenting a vagus nerve stimulation pulse train during presentation of an individual therapeutic sound, wherein the vagus nerve stimulation pulse train is generated by a subcutaneous device that provides electrical stimulation of the subject'"'"'s vagus nerve;

repeating the presentation of the plurality of paired therapeutic sounds; and

reducing the subject'"'"'s perception of tinnitus.

62. The method of claim 61, wherein presentation of each therapeutic sound is 500 milliseconds.

63. The method of claim 61, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

64. The method of claim 61, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

65. The method of claim 61, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

66. The method of claim 61, wherein the paired therapeutic sounds are repeated 300 times.

67. The method of claim 61, wherein the paired therapeutic sounds are repeated 300 times per day for twenty days.

68. The method of claim 61, wherein the paired therapeutic sounds are repeated 300 times in 150 minutes.

69. The method of claim 61, wherein the presentation of paired therapeutic sounds is random.

70. The method of claim 61, wherein the therapeutic sounds are tones.

71. The method of claim 61, wherein the presentation of the therapeutic sounds paired with vagus nerve stimulation results in a plasticity based remapping of an auditory cortex of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the remapping.

72. A method of treating tinnitus in a subject, comprising:

assessing a subject'"'"'s tinnitus symptoms;

implementing a tinnitus treatment process on the subject comprising;

selecting a therapeutic sound based on the assessed tinnitus symptoms, wherein the selected therapeutic sound consists of only one frequency;

pairing the therapeutic sound with a vagus nerve stimulation pulse train originating from a device that provides electrical stimulation to the vagus nerve;

repeating the tinnitus treatment process; and

reducing the subject'"'"'s perception of tinnitus.

73. The method of claim 72, wherein the therapeutic sound comprises a frequency outside tinnitus frequencies characterizing the subject'"'"'s tinnitus symptoms.

74. The method of claim 72, wherein presentation of the therapeutic sound is 500 milliseconds.

75. The method of claim 72, wherein the vagus nerve stimulation generates electroencephalogram (EEG) desynchronization.

76. The method of claim 72, wherein the vagus nerve stimulation has a current amplitude of 0.8 milliamps.

77. The method of claim 72, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

78. The method of claim 72, wherein the tinnitus treatment process is repeated 300 times.

79. The method of claim 72, wherein the tinnitus treatment process is repeated 300 times per day for twenty days.

80. The method of claim 72, wherein the tinnitus treatment process is repeated 300 times in 150 minutes.

81. The method of claim 72, wherein the therapeutic sound is a tone.

82. The method of claim 72, wherein the device is a subcutaneous device that provides electrical stimulation of the subject'"'"'s vagus nerve.

83. The method of claim 72, wherein the paired therapeutic sound with the vagus nerve stimulation pulse train results in a plasticity based remapping of an auditory cortex of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the remapping.

84. A method of treating tinnitus in a patient, comprising:

assessing a patient'"'"'s tinnitus symptoms;

implementing a tinnitus treatment process comprising;

selecting a sound based on the assessed tinnitus symptoms, wherein the selected sound consists of only one frequency; and

presenting the sound to the patient while stimulating the patient'"'"'s vagus nerve with a device that provides electrical stimulation to the vagus nerve;

repeating the tinnitus treatment process; and

reducing the patient'"'"'s perception of tinnitus.

85. The method of claim 84, wherein the sound selected when implementing the tinnitus treatment process is the same as the sound selected when the tinnitus treatment process is repeated.

86. The method of claim 84, wherein repeating the tinnitus treatment process comprises implementing the tinnitus treatment processes with each of the therapeutic sounds at least once.

87. The method of claim 84, wherein repeating the tinnitus treatment process comprises implementing the tinnitus treatment processes at least once for at least two different therapeutic sounds.

88. The method of claim 84, wherein repeating the tinnitus treatment process comprises implementing the tinnitus treatment processes a plurality of times for at least two different therapeutic sounds.

89. The method of claim 84, wherein the sound is presented for 500 milliseconds.

90. The method of claim 84, wherein the vagus nerve is stimulated so that electroencephalogram (EEG) desynchronization is generated.

91. The method of claim 84, wherein the vagus nerve is stimulated with a current amplitude of 0.8 milliamps.

92. The method of claim 84, wherein the vagus nerve is stimulated with a vagus nerve stimulation pulse train.

93. The method of claim 92, wherein the vagus nerve stimulation pulse train has a duration of 500 milliseconds.

94. The method of claim 84, wherein the tinnitus treatment process is repeated 300 times.

95. The method of claim 84, wherein the tinnitus treatment process is repeated 300 times per day for twenty days.

96. The method of claim 84, wherein the tinnitus treatment process is repeated 300 times in 150 minutes.

97. The method of claim 84, wherein the sound is a tone.

98. The method of claim 84, wherein the vagus nerve stimulation pulse train is generated by a subcutaneous device that provides electrical stimulation of the patient'"'"'s vagus nerve.

99. The method of claim 84, wherein the presentation of the sound to the patient while stimulating the patient'"'"'s vagus nerve results in a plasticity based remapping of an auditory cortex of the patient, and wherein the reduction of the patient'"'"'s perception of tinnitus is due to the remapping.