Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

GammaCore Active Device

+ GammaCore Active Device

+ GammaCore Sham Device

Device
Who is being recruted

Brain Diseases+3

+ Central Nervous System Diseases

+ Nervous System Diseases

From 18 to 65 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorElectroCore INC
Last updated: June 20, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01667250
Principal SponsorElectroCore INC
Last updated: June 20, 2018
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

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

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 65 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 DiseasesNervous System DiseasesHeadache DisordersHeadache Disorders, PrimaryMigraine Disorders

Criteria

7 inclusion criteria required to participate
Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms)
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
Experiences at least 15 headache days per month (over the last 3 months)
Has age of onset of migraine less than 50 years old
Show More Criteria
20 exclusion criteria prevent from participating
Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)
Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma
Has a history of carotid endarterectomy or vascular neck surgery on the right side
Has a known history or suspicion of substance abuse or addiction
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subjects will use an Active GammaCore Device

Group II

Sham
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.

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 6 locations

UCSF Headache Center

San Francisco, United StatesOpen UCSF Headache Center in Google Maps

Michigan Head Pain & Neurological Institute

Ann Arbor, United States

Headache Care Center

Springfield, United States

Montefiore Headache Center

The Bronx, United States
Completed6 Study Centers