Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (CH)
|ClinicalTrials.gov Identifier: NCT01792817|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment|
|Cluster Headache||Device: GammaCore Device: Sham GammaCore device|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache|
|Study Start Date :||February 2013|
|Primary Completion Date :||June 2014|
|Study Completion Date :||October 2014|
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
Treatment with sham stimulator
Experimental: GammaCore Device
Non-Invasive Vagus Nerve Stimulator
Treatment with active gammacore vagus nerve stimulator
- Headache pain intensity [ Time Frame: 15 minutes post stimulation ]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 ]Sustained treatment success at 1 hour post-treatment.
- Average mean attack intensities experienced per subject [ Time Frame: 15 minutes post-stimulation ]• 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792817
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|Study Director:||Lia Spitzer||ElectroCore LLC|