RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks

NACompletedINTERVENTIONAL
Enrollment

285

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

March 31, 2017

Conditions
Migraine
Interventions
DEVICE

gammaCore-S

At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.

DEVICE

gammaCore-S Sham

At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.

Trial Locations (10)

Unknown

University Aldo Moro, Ospedale Pediatrico, Bari

IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria, Bologna

University Hospital of Careggi, Florence

Fondazione IRCCS Istituto Neurologico C. Besta, Milan

"IRCSS National Neurological Institute C. Mondino Foundation", Pavia

S. Maria della Misericordia Hospital, Perugia

INM Neuromed IRCCS, Pozzilli

IRCCS San Raffaele Pisana, Rome

Sant'Andrea Hospital, Sapienza University of Rome, Rome

University of Turin, Turin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ElectroCore INC

INDUSTRY