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Non-Invasive Neurostimulation for the Prevention of Chronic Migraine | Clinical Trials | Clareo Health

COMPLETEDNA

Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine

NCT01667250•ElectroCore INC

Summary

The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is between the ages of 18 and 65 years.
•Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
•Experiences at least 15 headache days per month (over the last 3 months).
•Has age of onset of migraine less than 50 years old.
•Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
•Is able to provide written Informed Consent
•Agrees to refrain from changing the type or dosage of any prophylactic medications for indications other than chronic migraine that in the opinion of the clinician may interfere with the study

Exclusion Criteria

•Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
•Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
•Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
•Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction)
•Has had a previous bilateral, right, or left cervical vagotomy.
•Has uncontrolled high blood pressure.
•Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
•Has a history of carotid endarterectomy or vascular neck surgery on the right side.
•Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
•Has a recent or repeated history of syncope.
+10 more criteria

Locations (6)

UCSF Headache Center

San Francisco, California, United States

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

Headache Care Center

Springfield, Missouri, United States

Montefiore Headache Center

The Bronx, New York, United States

Carolina Headache Institute

Chapel Hill, North Carolina, United States

Thomas Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

June 20, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Migraine

Interventions

GammaCore Active Device

DEVICE

GammaCore Sham Device

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

Inclusion Criteria

Exclusion Criteria

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