Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (CH)
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|ClinicalTrials.gov Identifier: NCT01792817|
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cluster Headache||Device: GammaCore Device: Sham GammaCore device||Not Applicable|
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|
|Actual Primary Completion Date :||June 2014|
|Actual 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
- Number of Participants With Repsonse to Treatment [ 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.
A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
- Sustained Treatment Success at 1 Hour Post-Treatment [ Time Frame: For 1 hour post stimulation ]Sustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period
- Average Mean Attack Intensities Experienced Per Subject [ Time Frame: 15 minutes post-stimulation ]Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . 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. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.
- Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events. [ Time Frame: 4 weeks, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792817
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|Study Director:||Lia Spitzer||ElectroCore INC|