NCT03410628

Non-invasive Neurostimulation for the Relief of Migraine

Non-invasive Neurostimulation of the Vagus Nerve With the gammaCore Device for the Relief of Pain and Allodynia Associated With Migraine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this feasibility study is to gather preliminary information on the safety and effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated with acute migraine in adults.

Detailed description

This is a prospective, non-randomized, unblinded, multi-center feasibility study; 25 subjects will be enrolled at up to 5 study centers. Subjects considered for participation in this study will be those who have a diagnosis and documented history at least 2 episodes of acute headache pain and allodynia associated with migraine per month, but no more than 15 headache days per month. Subjects may, but are not required to experience prodromal symptoms, such as aura, or concomitant photophobia, phonophobia, or nausea with their migraine episodes, so long as their headaches meet the IHS-Classification criteria for migraine. Subjects will be screened for study eligibility and consented for study participation at presentation to the headache clinic. Once consented, subjects will be trained by the Investigator(s) at the study center on at-home use of the GammaCore device and on study data collection and other requirements. Each subject enrolled in this study will treat up to 3 migraine headaches at home over a period of up to 6 weeks. From the onset of headache pain, the subject will withhold usual migraine medications and wait until the pain becomes moderate or severe, or 30 minutes, whichever is sooner. At that point, the subject will self-administer a first stimulation treatment, which is 90 seconds in duration.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	gammaCore	Non-invasive vagal nerve stimulator

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2018-01-25
• Last updated: 2018-07-26
• Results posted: 2018-07-26