Completed
Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
What is being tested
n-VNS
Device
Who is being recruted
Brain Diseases+3
+ Central Nervous System Diseases
+ Migraine Disorders
From 18 to 55 Years
+23 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: February 2012
Summary
Principal SponsorElectroCore INC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2012
Actual date on which the first participant was enrolled.The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
Official TitleNon-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Principal SponsorElectroCore INC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesCentral Nervous System DiseasesMigraine DisordersNervous System DiseasesHeadache DisordersHeadache Disorders, Primary
Criteria
5 inclusion criteria required to participate
Is between the ages of 18 and 55 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 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
Has age of onset of migraine less than 50 years old.
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18 exclusion criteria prevent from participating
Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
Has a lesion (including lymphadenopathy) 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), coronary artery disease or recent myocardial infarction.
Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentaln-VNS active therapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Suspended
Suspended
New York Headache Center
New York, United StatesSuspended
Montefiore Headache Center
The Bronx, United StatesCompleted3 Study Centers