Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667250
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
ElectroCore LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: GammaCore Active Device Device: GammaCore Sham Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: GammaCore Active Device
Subjects will use an Active GammaCore Device
Device: GammaCore Active Device
Sham Comparator: GammaCore Sham Device
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.
Device: GammaCore Active Device Device: GammaCore Sham Device

Primary Outcome Measures :
  1. Safety, this is a pilot study [ Time Frame: Duration of Study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • Has a recent or repeated history of seizure.
  • Has a known history or suspicion of substance abuse or addiction.
  • Has had a surgery for migraine prevention.
  • Has received Botox injections for migraine prevention within the past 6 months.
  • Has taken medications for migraine prophylaxis in the previous 30 days.
  • In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.
  • Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control.
  • Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  • 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).
  • Is a relative of or an employee of the investigator or the clinical study site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667250

United States, California
UCSF Headache Center
San Francisco, California, United States, 94143
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Headache Care Center
Springfield, Missouri, United States, 65807
United States, New York
Montefiore Headache Center
Bronx, New York, United States, 10461
United States, North Carolina
Carolina Headache Institute
Chapel Hill, North Carolina, United States, 27516
United States, Pennsylvania
Thomas Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
ElectroCore LLC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ElectroCore LLC Identifier: NCT01667250     History of Changes
Other Study ID Numbers: M-US-02
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: February 2016

Keywords provided by ElectroCore LLC:
vagus nerve stimulation
vagal nerve stimulation
chronic migraine
non invasive

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases