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Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache — CH  

Cluster Headache Clinical Trial

Official title:
Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache

Clinical Trial 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.

Clinical Trial Description

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:

1. Active Treatment with the GammaCore Device

2. Sham Treatment with a placebo device

Phase 2 - One Arm:

Active Treatment with the GammaCore Device ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01792817
Study type Interventional
Source ElectroCore INC
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date October 2014
View Details
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