NCT01792817

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DEVICE	GammaCore	Treatment with active gammacore vagus nerve stimulator
DEVICE	Sham GammaCore device	Treatment with sham stimulator

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-06-01
• Completion: 2014-10-01
• First posted: 2013-02-15
• Last updated: 2019-12-17
• Results posted: 2018-05-17

Locations

20 sites across 1 country: United States