Treatment of dementia by nerve stimulation

• US 5,269,303 A
• Filed: 02/22/1991
• Issued: 12/14/1993
• Est. Priority Date: 02/22/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Terry, Reese S. Jr., Wernicke, Joachim F.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Casler, Brian L.
• Application Number:
  US07/660,404
• Time in Patent Office: 1,026 Days
• Field of Search: 128/784.5, 128/642, 128/421-423, 128/419 R, 128/419 C, 128/420.5, 128/731, 128/732
• US Class Current: 607/45
• 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 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

A method of treating symptoms of dementia, including cortical dementia, subcortical dementia, and multi-infarct dementia, includes selecting a patient suffering from dementia, and applying to the patient'"'"'s vagus nerve an electrical stimulation signal having parameter values selected to modulate the electrical activity of the vagus nerve in a manner to modulate the activity of preselected portions of the reticular activating system of the brain stem.

Claims

1. A method of treating patients with dementia, which comprises the steps of:

selecting a patient suffering from dementia, and

applying a stimulating signal with predetermined electrical parameters to the patient'"'"'s vagus nerve to selectively modulate the electrical activity of preselected afferent fibers of the vagus nerve distributed to the reticular activating system in the patient'"'"'s brain stem and thereby modulate the electrical activity of preselected portions of the reticular activating system of the patient, to relieve a symptom of the dementia.

2. The method of claim 1, including

applying said stimulating signal to the patient'"'"'s vagus nerve via a nerve electrode implanted on the nerve in the patient'"'"'s neck.

3. The method of claim 1, including

applying said stimulating signal continuously to the patient'"'"'s vagus nerve.

4. The method of claim 1, including

applying said stimulating signal periodically to the patient'"'"'s vagus nerve.

5. The method of claim 1, including

applying said stimulating signal intermittently to the patient'"'"'s vagus nerve.

6. The method of claim 1, including

setting electrical parameters including timing and amplitude of said stimulating signal to stimulate said preselected afferent fibers of the patient'"'"'s vagus nerve.

7. The method of claim 6, including

implanting a neurostimulating device into the patient to generate said stimulating signal for application to the patient'"'"'s vagus nerve.

8. The method of claim 7, including

formulating the stimulating signal as a predetermined sequence of electrical pulses for application to the patient'"'"'s vagus nerve.

9. The method of claim 8, further including

selectively setting parameter values of the sequence of electrical pulses including pulse width, output current, frequency, on time and off time, for the selective modulation of electrical activity of said preselected portions of the reticular activating system of the patient.

10. A method for treating and controlling symptoms of dementia in a patient, which comprises the steps of:

selecting a patient suffering from dementia,

implanting an electrode on the patient'"'"'s vagus nerve for application of an electrical signal having predetermined electrical parameter values to the vagus nerve, and

delivering the electrical signal to the implanted electrode to selectively modulate the electrical activity of the vagus nerve and thereby treat a symptom of the dementia exhibited by the patient.

11. The method of claim 10, including:

setting the electrical parameter values of the electrical signal delivered to the implanted electrode for modulating the electrical activity of the vagus nerve to desynchronize the patient'"'"'s electroencephalogram (EEG).

12. The method of claim 10, including:

setting the electrical parameter values of the electrical signal delivered to the implanted electrode for modulating the electrical activity of the vagus nerve to desynchronize high voltage slow wave activity and increase background activity of the patient'"'"'s EEG.

13. The method of claim 10, including:

setting the electrical parameter values of the electrical signal delivered to the implanted electrode for modulating the electrical activity of the vagus nerve to desynchronize paraxysmal activity of the patient'"'"'s EEG.

14. A method of controlling the function of a neurostimulator device adapted to be implanted in a human patient suffering from symptoms of dementia, including the steps of:

selecting electrical parameters including pulse amplitude, pulse width and on and off times of the electrical output signal of a pulse generator of the neurostimulator device to develop an electrical signal for application to a lead/electrode assembly implanted on the vagus nerve of the patient to treat the patient'"'"'s dementia by predetermined modulation of the electrical activity of the vagus nerve, and

programming the pulse generator after implantation to set the selected parameters of its electrical output signal for treatment of the dementia when applied to the implanted lead/electrode assembly.

15. A method for use in advancing the treatment and control of symptoms of dementia in a human patient, characterized by the steps of:

providing a lead assembly including an electrical lead having a proximal and a distal end with a stimulating electrode connected at its distal end, for implantation on the vagus nerve of a patient suffering from dementia,

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

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

restricting programmable ranges of said variables electrical parameters of the electrical pulse sequences to values which in combination will stimulate the vagus nerve and thereby modulate its electrical activity and the electrical activity of preselected portions of the reticular activating system of the patient'"'"'s brain stem when one or more programmed pulse sequences are applied to the vagus nerve via the lead assembly, to vary the electrical activity of the reticular activating system in a predetermined manner according to the nature of the dementia to be treated,

adapting the stimulus generator for restriction of the programming of the electrical parameters of the electrical pulse sequences to physician control, and

supplying the stimulus generator and lead assembly for the treatment and control of symptoms of dementia.

16. The method of claim 15, including:

implementing the programmable stimulus generator to include among the selectively variable electrical parameters of the electrical pulse sequences the pulse width, amplitude, frequency, sequence duration and sequence intervals.