# US 5,215,086 A · Therapeutic treatment of migraine symptoms by stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,215,086 A - Document ID: US5215086A - Status: Granted - Kind: A - Application number: 07/695,216 - Filed: 1991-05-03 - Granted: 1993-06-01 - Earliest claimed: 1991-05-03 - Assignees: Cyberonics, Inc. - Inventors: Reese S. Terry, Jr.; Joachim F. Wernicke; Ross G. Baker, Jr. - Web page: https://patentgrep.com/patent/US5215086A ## CPC - A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)} - A61N 1/36075: {Headache or migraine} - A61N 1/36132: {using patient feedback} - A61N 1/36135: {using physiological parameters} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Method and apparatus for treating and controlling migraine by selectively applying a predetermined electrical signal to the patient's vagus nerve for stimulation thereof to alleviate the migraine attack. The signal is a pulse waveform having parameters programmed to desynchronize the patient's EEG if paroxysmal activity is detected in the EEG, or to synchronize the EEG if low voltage fast wave activity is detected. Alternatively, the application of the stimulating signal to the vagus nerve may be initiated manually by the patient upon recognition of the onset of a migraine attack. The neurostimulator device implanted in the patient to generate the appropriate signal has a power down circuit to conserve battery power between migraine episodes. ## Claims ### Claim 1 A therapeutic method of treating symptoms of migraine in patients experiencing migraine attacks, which includes the steps of: detecting a physiological symptom associated with onset of a migraine attack in a patient under treatment, and in response to detection of such symptom, selectively applying a programmed electrical stimulus to the patient's vagus nerve for modulating the electrical activity of preselected fibers of the vagus nerve in a manner to alleviate the migraine attack. ### Claim 2 (depends on 1) The method of claim 1, wherein: the detected symptom is paroxysmal activity of the patient's EEG, the predetermined electrical stimulus is a signal in the form of a pulse waveform having a plurality of programmable signal parameters, and the method further includes programming at least some of the signal parameters of the pulse waveform to modulate the vagus nerve electrical activity in a manner to desynchronize the patient's EEG upon detection of such EEG paroxysmal activity. ### Claim 3 (depends on 1) The method of claim 1, wherein: the detected symptom is excessive low voltage, fast wave activity of the patient's EEG, the predetermined electrical stimulus is a signal in the form of a pulse waveform having a plurality of programmable signal parameters, and the method further includes programming at least some of the signal parameters of the pulse waveform to modulate the vagus nerve electrical activity in a manner to synchronize the patient's EEG upon detection of such low voltage, fast wave activity of the EEG. ### Claim 4 (depends on 1) The method of claim 1, wherein: the detecting of such symptom is performed by detecting one of (i) a visual pattern constituting an aura perceived by the patient, (ii) abnormal EEG waves over the central temporal region of the patient, and (iii) abnormal sleep patterns of the patient, associated with onset of a migraine attack. ### Claim 5 (depends on 1) The method of claim 1, wherein: the symptom is a subjective indication perceived by the patient as being associated with the onset of an episode of migraine, and the selective application of the stimulus is performed by the patient manually initiating such application upon perceiving such subjective indication. ### Claim 6 (depends on 5) The method of claim 5, wherein the electrical stimulus is a pulse waveform, and including: programming parameters of the pulse waveform including pulse width, output current, output voltage, frequency and on and off times as prescribed to treat the migraine of the particular patient, prior to applying the pulse waveform to the patient's vagus nerve. ### Claim 7 (depends on 1) The method of claim 1, wherein: the electrical stimulus is applied to the patient's vagus nerve by application at a site on the vagus nerve in the patient's neck. ### Claim 8 (depends on 1) The method of claim 1, wherein: the electrical stimulus is a pulse waveform having parameter values including pulse width, output current or output voltage, frequency, on time and off time, which are selectively programmable, and the electrical stimulus is programmed by programming at least some of said parameter values prior to applying the stimulus to the patient's vagus nerve. ### Claim 9 A method of treating patients suffering from migraine episodes, which includes the steps of: providing an electrical stimulus generator with an electrical output signal having parameters which are programmable within respective ranges predetermined, when the programmed output signal is properly applied to the vagus nerve of the patient, to relieve symptoms of migraine, and adapting the stimulus generator to generate its output signal upon selective activation of the stimulus generator, implanting the stimulus generator in the patient's body, and implanting a nerve electrode to receive the output signal of the stimulus generator on the vagus nerve of the patient, and programming at least some of the programmable parameters of the output signal of the stimulus generator according to the nature of the migraine suffered by the particular patient under treatment to modulate the electrical activity of the vagus nerve in a predetermined manner, upon activation of the stimulus generator and consequent application of the programmed output signal thereof to the vagus nerve through the nerve electrode implanted thereon, to alleviate symptoms of a migraine episode experienced by the patient. ### Claim 10 (depends on 9) The method of claim 9, wherein: the output signal of the stimulus generator is a pulse waveform and the programmable parameters thereof include pulse width, output current or output voltage, frequency, on time and off time, and the implanting of the nerve electrode is performed by securing the electrode to the vagus verve at a site in the patient's neck and electrically connecting the electrode via a conductive lead to the stimulus generator. ### Claim 11 (depends on 9) The method of claim 9, wherein: the adapting of the stimulus generator to generate its output signal upon selective activation is performed by providing the stimulus generator with a sensor to detect a symptom associated with onset of a migraine episode and to activate the stimulus generator upon such detection, and including implanting the sensor together with the stimulus generator. ### Claim 12 (depends on 9) The method of claim 9, further including: deactivating the output signal of the stimulus generator after a predetermined time interval of activation thereof, to conserve power in the stimulus generator. ### Claim 13 Apparatus for therapy of patients suffering from migraine by treating symptoms of the migraine associated, in some patients, with a synchronized EEG and, in other patients, with a desynchronized EEG, in which the apparatus includes an implantable programmable neurostimulator device adapted to generate a programmed electrical output signal upon activation of the device, and an implantable electrical lead assembly connectable at its proximal end to the neurostimulator device to receive the programmed output signal thereof and having an electrode at its distal end adapted to be secured to the patient's vagus nerve for electrical excitation of the nerve to modulate the electrical activity of the nerve, characterized in that the apparatus further includes: sensor means electrically coupled to the neurostimulator device for detecting the occurrence of a predetermined symptom of the migraine, activator means responsive to detection of such occurrence for activating the neurostimulator device to apply its programmed electrical output signal to the electrical lead assembly, the neurostimulator device including means for rendering the output signal parameters thereof programmable only within respective ranges preselected for desynchronizing or synchronizing the patient's EEG according to the specific nature of the migraine suffered by the particular patient under treatment, whereby when the output signal is so programmed and the activator means detects the occurrence of the predetermined symptom of the migraine, the electrical activity of the vagus nerve is modulated to desynchronize or synchronize the patient's EEG according to the selected programming so as to relieve the detected symptom of the migraine. ### Claim 14 (depends on 13) The apparatus of claim 13, wherein said neurostimulator device further includes: power down means for reducing the power consumption of the neurostimulator device between episodes of migraine. ### Claim 15 (depends on 13) The apparatus of claim 13, in which: the neurostimulator device further includes manual activation means for alternative patient activation of the neurostimulator device to cause generation of the programmed electrical output signal thereof. ### Claim 16 (depends on 15) The apparatus of claim 15, wherein said neurostimulator device includes: power conservation means responsive to the passage of a predetermined time interval following activation of the neurostimulator device for deactivation thereof to power the neurostimulator device down until subsequent activation thereof by the activator means or the manual activation means. ### Claim 17 (depends on 13) The apparatus of claim 13, in which: the neurostimulator device further includes analyzer means for assisting in the determination that a symptom of migraine is occurring. ### Claim 18 (depends on 13) The apparatus of claim 13, in which the neurostimulator device includes: means for generating the electrical output signal of the device in the form of a pulse waveform, and selection means for programming signal parameters of the pulse waveform, including width of pulses, output current, output voltage, pulse frequency, and on time and off time of the waveform.