Systems and methods for stimulating and/or monitoring loci in the brain to treat inflammation and to enhance vagus nerve stimulation

Inventors

Levine, Jacob A.Faltys, Michael A.

Assignees

SetPoint Medical Corp

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Publication Number

US-11311725-B2

Patent

Publication Date

2022-04-26

Expiration Date


Abstract

Described herein are methods and systems for using EEG recordings to improve vagus nerve stimulation (VNS) therapy. In particular, described herein are methods and systems for using EEG recordings to detect P300 and/or activation of the nucleus basalis and/or the locus coeruleus to determine the efficacy of VNS. The EEG recordings can be used to provide feedback control to help optimize stimulation parameters and to screen for patients that respond well to VNS therapy.

Core Innovation

The invention is directed to a method of titrating a vagus nerve stimulation dosage of an implanted vagus nerve stimulator for inducing long term potentiation of the inflammatory reflex in a patient. The method stimulates the vagus nerve according to a dosage of stimulation parameters to stimulate an anti-inflammatory pathway, records an electroencephalogram (EEG), and analyzes the recorded EEG to detect activation of at least one of the nucleus basalis and the locus coeruleus indicating stimulation of the anti-inflammatory pathway.

The EEG activation result is used as the control basis for changing the stimulation parameters. If the recorded EEG indicates activation of at least one of the nucleus basalis and the locus coeruleus, the method decreases one or more of an amplitude, a pulse width, a pulse frequency, and a duration of the stimulation parameters, and if activation is not indicated, the method increases one or more of the amplitude, the pulse width, the pulse frequency, and the duration.

In a related independent method, the invention further includes recording a baseline EEG before stimulating the vagus nerve and recording a second EEG while stimulating the vagus nerve with a dose of vagus nerve stimulation. From the baseline EEG and the second EEG, the method determines whether at least one of the nucleus basalis and the locus coeruleus has been activated indicating that the anti-inflammatory pathway has been stimulated by the vagus nerve stimulation.

The cycle of stimulating, recording, analyzing, determining, and adjusting is repeated until the dosage reaches a minimum level necessary to modulate the inflammatory reflex. The dose is adjusted by decreasing stimulation parameters when activation is detected and increasing stimulation parameters when activation is not detected.

Claims Coverage

Two independent claims cover EEG-based titration of an implanted vagus nerve stimulator dosage to induce long term potentiation of the inflammatory reflex by detecting activation of nucleus basalis and/or locus coeruleus from EEG and adjusting stimulation parameters until a minimum level necessary is reached. The claims include two inventive features centered on EEG-triggered dose adjustment and iterative titration using activation detection as the decision criterion.

Eeg-guided titration until minimum level necessary

A method of titrating a vagus nerve stimulation dosage of an implanted vagus nerve stimulator for inducing long term potentiation of the inflammatory reflex in a patient, stimulating the vagus nerve according to a dosage of stimulation parameters, recording an electroencephalogram (EEG) while stimulating, analyzing the recorded EEG to detect activation of at least one of the nucleus basalis and the locus coeruleus indicating stimulation of the anti-inflammatory pathway, adjusting the dose by decreasing stimulation parameters when EEG indicates activation and increasing stimulation parameters when EEG does not indicate activation, and repeating the steps until the dose is at a minimum level necessary to modulate the inflammatory reflex.

Baseline versus second Eeg determination for activation

A method of titrating a vagus nerve stimulation dosage of an implanted vagus nerve stimulator for inducing long term potentiation of the inflammatory reflex in a patient, recording a baseline EEG before stimulating the vagus nerve to stimulate an anti-inflammatory pathway, recording a second EEG while stimulating the vagus nerve with a dose of vagus nerve stimulation, determining from the baseline EEG and the second EEG if at least one of the nucleus basalis and the locus coeruleus has been activated indicating that the anti-inflammatory pathway has been stimulated by the vagus nerve stimulation, adjusting the dose by decreasing stimulation parameters when activation is indicated and increasing stimulation parameters when activation is not indicated, and repeating the steps until the dosage is at a minimum level necessary to modulate the inflammatory reflex.

Across both independent claims, the core coverage is for iterative titration of an implanted vagus nerve stimulator dosage using EEG analysis to detect activation of at least one of the nucleus basalis and the locus coeruleus, with stimulation parameters adjusted in opposite directions depending on whether activation is detected, until a minimum level necessary to modulate the inflammatory reflex is reached. The second independent claim further specifies a baseline EEG and a second EEG comparison to support the activation determination that drives the dose adjustment.

Stated Advantages

Documented Applications

No documented applications found

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