At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
GammaCore +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 Treatment of Cluster Headache
In Brief
A clinical study evaluating GammaCore and Sham GammaCore device for Cluster Headache. Completed, enrolled 150 participants across 20 sites.
Detailed Summary
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCluster Headache
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionJun 2014
Study CompletionOct 2014
TodayJul 2026
First PostedFeb 15, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJun 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago
Interventions
GammaCoredevice
Treatment with active gammacore vagus nerve stimulator
Sham GammaCore devicedevice
Treatment with sham stimulator