Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (CH)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache|
- Headache pain intensity [ Time Frame: 15 minutes post stimulation ] [ Designated as safety issue: No ]The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.
- Sustained headache intensity pain [ Time Frame: For 1 hour post stimulation ] [ Designated as safety issue: No ]Sustained treatment success at 1 hour post-treatment.
- Average mean attack intensities experienced per subject [ Time Frame: 15 minutes post-stimulation ] [ Designated as safety issue: No ]• The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group.
- Incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events. [ Time Frame: Duration Phase 1 ] [ Designated as safety issue: Yes ]The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham GammaCore device
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
|Device: Sham GammaCore device|
Experimental: GammaCore Device
Non-Invasive Vagus Nerve Stimulator
Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double blinded, sham controlled treatment (active or sham) phase
Phase 2: Prospective, non-randomized, active treatment phase.
Phase 1 - Two Arms:
- Active Treatment with the GammaCore Device
- Sham Treatment with a placebo device
Phase 2 - One Arm:
Active Treatment with the GammaCore Device
Show 22 Study Locations
|Study Director:||Lia Spitzer||ElectroCore LLC|