Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine

ElectroCore INC3 sites in 1 country30 target enrollmentFebruary 2012

ConditionsMigraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Migraine
Sponsor: ElectroCore INC
Enrollment: 30
Locations: 3
Primary Endpoint: Safety - Number of Participants With Adverse Effects
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

July 25, 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ElectroCore INC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Safety - Number of Participants With Adverse Effects

Time Frame: End of Study - 7 weeks

The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.

Secondary Outcomes

Change in Photophobia (Visual) From Baseline to 120 Minutes(Base line and 120 minutes)
Change in Phonophobia (Auditory) From Baseline to 120 Minutes(Baseline and 120 minutes)
Mean Change in Headache Pain From Baseline to 120 Minutes(120 minutes)
Mean Change in Nausea From Baseline to 120 Minutes(Baseline 120 minutes)
Mean Change in Functional Disability(Baseline and 120 minutes)