Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
This study has been completed.
Information provided by (Responsible Party):
First received: February 10, 2012
Last updated: October 4, 2013
Last verified: October 2013
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.
Device: GammaCore device
||Primary Purpose: Treatment
||Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Primary Outcome Measures:
- Safety [ Time Frame: End of Study ]
| Study Start Date:
| Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Is able to give written Informed Consent
- 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.
- Has had a previous bilateral or right cervical vagotomy.
- Has a clinically significant irregular heart rate or rhythm.
- Has uncontrolled high blood pressure.
- Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, 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 history or suspicion of narcotic abuse.
- Takes medication for acute headaches more than 10 days per month.
- Is pregnant, nursing, thinking of becoming pregnant in the next 3 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532830
|UCSF Headache Center
|San Francisco, California, United States, 94143 |
|Montefiore Headache Center
|Bronx, New York, United States, 10461 |
|New York Headache Center
|New York, New York, United States, 10021 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2012
||October 4, 2013
||United States: Food and Drug Administration
Keywords provided by ElectroCore LLC:
vagus nerve stimulation
vagal nerve stimulation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases