External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

Part of paid clinical trials in Darien, Connecticut.

Sponsor
Cefaly Technology
Study ID
NCT06788977
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • external Trigeminal Nerve Stimulation — DEVICE
    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.

Study Details

This online registry aims to understand the potential benefits and safety of external trigeminal nerve stimulation for the treatment of migraine in pregnant women. Women do not need to use external trigeminal nerve stimulation or any other form of migraine treatment to participate in the registry. The main question it aims to answer is: Is external trigeminal nerve stimulation a safe and effective option for migraine treatment during and after pregnancy? There are no required changes in migraine treatment to participate in this registry. Participants may or may not use external trigeminal nerve stimulation or any other treatment they currently use and may still participate in the registry. There are no clinic or research visits, as the registry is entirely online. Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months.

Key Dates

Start date
Nov 25, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: External Trigeminal Nerve Stimulation (eTNS) group
    This group reflects participants who are already using eTNS therapy during the pregnancy, as well as participants who start using eTNS therapy at any point during their pregnancy. Any participant may opt to continue or discontinue eTNS treatments during the registry period, which will not affect their ability to participate.
  • Arm: Non-eTNS group
    This group reflects participants who have not used eTNS therapy during and throughout their pregnancy. If a participant who initially does not use eTNS therapy during pregnancy decides to start eTNS therapy at any point during their pregnancy, they will be assigned to the eTNS group.

Primary Outcome Measure

Rate of miscarriage per trimester [ Time Frame: through study completion average 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=trueDarienConnecticut06820
Lilliana Delmonico
[email protected]
(475) 270-1033
Michael Johnson

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

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