Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01667250
First received: August 15, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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 Intervention
Chronic Migraine
Device: GammaCore Active Device
Device: GammaCore Sham Device

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Safety, this is a pilot study [ Time Frame: End of Study ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GammaCore Active 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667250

Locations
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
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01667250     History of Changes
Other Study ID Numbers: M-US-02
Study First Received: August 15, 2012
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 15, 2014