External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

RecruitingOBSERVATIONAL
Enrollment

550

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

November 27, 2030

Study Completion Date

December 31, 2030

Conditions
PregnancyMigraineHeadachePostpartumDepressionAnxiety
Interventions
DEVICE

external Trigeminal Nerve Stimulation

"External trigeminal nerve stimulation (e-TNS) is a non-invasive, nondrug option for the acute and preventative treatment of migraine. The device is marketed under the trade name CEFALY and has received clearance from the US Food and Drug Administration (FDA) for the acute and preventative treatment of migraine.~The CEFALY device provides transcutaneous stimulation of the supraorbital and supratrochlear branches of the ophthalmic division of the Trigeminal nerve. Patients apply a self-adhesive electrode pad to their forehead, then place the CEFALY generator over the electrodes, resulting in a magnetic connection. The user then selects a treatment program for acute or preventative therapy, which lasts for 60 or 20 minutes."

Trial Locations (1)

06820

RECRUITING

https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true, Darien

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cefaly Technology

INDUSTRY