Treatment of neuropsychiatric disorders by nerve stimulation

• US 5,299,569 A
• Filed: 05/03/1991
• Issued: 04/05/1994
• Est. Priority Date: 05/03/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Zabara, Jacob, Terry, Reese S. Jr., Wernicke, Joachim F.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/695,420
• Time in Patent Office: 1,068 Days
• Field of Search: 128/421, 128/419 S, 128/419 C, 128/731
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

Method and apparatus for treating and controlling neuropsychiatric disorders including schizophrenia, depression, and borderline personality disorder by selectively applying a predetermined electrical signal to the patient'"'"'s vagus nerve for stimulation thereof to alleviate the symptoms of the disorder being treated. The electrical signal may be applied continuously, periodically, or intermittently to the vagus nerve depending, in part, on the nature of the disorder being treated. In certain instances, the electrical signal is applied upon detection of an event indicative of onset of the disorder. In other instances, the electrical signal is selectively applied at will to the vagus nerve, such as by patient activation of the signal generator. Parameter values of the electrical signal including pulse width, output current, frequency, on time and off time, are selectively programmable.

Claims

1. A method of treating patients with neuopsychiatric disorders, which includes

selecting a patient suffering form a neuropsychiatric disorder,

determining the type of neuropsychiatric disorder exhibited by the patient, and

selectively applying a predetermined electrical stimulus to the patient'"'"'s vagus nerve for modulating the electrical activity thereof in a manner to alleviate the symptoms of the neuropsychiatric disorder exhibited by the patient being treated.

2. The method of claim 1, wherein the neuropsychiatric disorder being treated is schizophrenia, and

the predetermined stimulus is an electrical signal in the form of a pulse waveform with signal parameters programmed to increase desynchronous activity of the patient'"'"'s EEG during waking hours, and to increase synchronous activity of the EEG during sleep.

3. The method of claim 1, wherein the neuropsychiatric disorder being treated is one of schizophrenia, depression or a borderline personality disorder, and further including

detecting an event indicative of onset of the disorder, and

initiating application of the predetermined electrical stimulus upon such detection.

4. The method of claim 3, wherein the neuropsychiatric disorder being treated is schizophrenia, and

the detected event is one of (i) EEG beta waves over the central temporal region and (ii) abnormal sleep patterns, of the patient.

5. The method of claim 3, wherein the neuropsychiatric disorder being treated is depression, and

the detected event is one of (i) EEG alpha and beta waves, and (ii) predetermined level of REM activity during sleep, of the patient.

6. The method of claim 3, wherein the neuropsychiatric disorder being treated is borderline personality disorder, and

the detected event is a predetermined level of REM activity during sleep by the patient.

7. The method of claim 1, wherein the neuropsychiatric disorder being treated in depression, and

the predetermined stimulus is an electrical signal in the form of a pulse waveform with signal parameters programmed to increase synchronous activity of the patient'"'"'s EEG during the patient'"'"'s waking hours, and to increase the patient'"'"'s rapid eye movement (REM) activity during sleep.

8. The method of claim 1, wherein

the predetermined stimulus is an electrical signal selected to activate the patient'"'"'s vagus never to modify the release of serotonin in the patient'"'"'s brain.

9. The method of claim 8, wherein the neuropsychiatric disorder being treated is depression, and including

applying the predetermined electrical stimulus to the patient'"'"'s vagus nerve continually over a relatively long period of time to increase the release of serotonin.

10. The method of claim 1, wherein the neuropsychiatric disorders being treated is depression, including

manually activating the predetermined stimulus as an electrical signal in the form of a pulse waveform with signal parameters programmed to alleviate symptoms of the depression.

11. The method of claim 1, wherein the neuropsychiatric disorder being treated is borderline personality disorder, and

the predetermined stimulus is an electrical signal in the form of a pulse waveform with signal parameters programmed to increase the patient'"'"'s REM latency and decrease REM intensity during sleep.

12. The method of claim 1, wherein

said stimulus is an electrical signal in the form of a pulse waveform with programmable signal parameters, and is applied to a nerve electrode implanted in the patient'"'"'s neck on the vagus nerve.

13. The method of claim 12, wherein

said electrical signal is further programmable for any of continuous periodic or intermittent application to the patient'"'"'s vagus nerve.

14. The method of claim 12, wherein

said electrical signal is selectively applied at will to the patient'"'"'s vagus nerve.

15. The method of claim 12, wherein

the parameter values of the electrical signal including pulse width, output current, frequency, on time and off time, are selectively programmable.

16. A new use for a neurostimulator device adapted to be implanted in a human patient, in which the device comprises an electrical signal generator which is programmable to generate an electrical output signal having selected signal parameters, and an electrical lead adapted to be connected at a proximal end thereof to the signal generator, the lead including an electrode electrically connected to a distal end of the lead and having a configuration for encompassing a portion of the length of a nerve so that the electrode is adapted to be implanted on the patient'"'"'s vagus nerve to modulate the electrical activity of the nerve in response to application of the programmed electrical output signal from the signal generator to the lead, the new use of the neurostimulator device comprising the steps of:

implanting said electrode on the vagus nerve of the patient,

electrically connecting the proximal end of the lead to said signal generator,

programming the output signal of the signal generator to constitute a pulse waveform with parameter values of pulse width, output current, frequency, and on and off times selected for therapeutic treatment and control of a neuropsychiatric disorder of the patient among the group of such disorders consisting of schizophrenia, depression, borderline personality disorder.

17. The new use of the neurostimulator device of claim 16, including:

detecting an event indicative of onset of the neuropsychiatric disorder being treated, and, in response to such detected event, applying the output signal of the signal generator to the lead, so as to modulate the electrical activity of the vagus nerve to alleviate symptoms of the neuropsychiatric disorder being treated.

18. A method for use in advancing the treatment and control of neuropsychiatric disorders, including the steps of

providing an electrical lead with a stimulating electrode assembly at its distal end for implantation on a patient'"'"'s vagus nerve,

providing a programmable stimulus generator for generating electrical pulse sequences with selectively variable electrical parameters for selective application to the lead/electrode assembly when implanted on the vagus nerve,

incorporating an electrical connector in the stimulus generator to accommodate electrical connection of the proximal end of the electrical lead to the stimulus generator,

restricting the programmable ranges of the variable parameters of the electrical pulse sequences to values which in combination will stimulate the vagus nerve and thereby modulate its electrical activity when one or more programmed pulse sequences are applied to the nerve via the lead/electrode assembly, to alleviate symptoms of the particular neuropsychiatric disorder to be treated,

adapting the stimulus generator for physician control of the programming, and

supplying the stimulus generator and lead/electrode assembly for the treatment and control of neuropsychiatric disorders.

19. The method of claim 18, wherein the selectively variable electrical parameters include pulse width, amplitude and frequency, sequence duration and intervals.