At a glance
ClinicalIndex Comparison RecordN/ACompleted· 59 enrolled
Drug / intervention
GammaCore Active Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine
In Brief
A clinical study evaluating GammaCore Active Device and GammaCore Sham Device for Chronic Migraine. Completed, enrolled 59 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Migraine
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionMay 2014
TodayJul 2026
First PostedAug 17, 2012
Enrollment StartOct 1, 2012
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.9 years ago
Interventions
GammaCore Active Devicedevice
GammaCore Sham Devicedevice