RecruitingNCT06788977

External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

CEFALY Pregnancy Registry

Sponsor

Cefaly Technology

Enrollment

550 participants

Start Date

Nov 25, 2024

Study Type

OBSERVATIONAL

Conditions

Pregnancy Depression Anxiety Postpartum Migraine Headache

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable device that gently stimulates the trigeminal nerve (a major nerve in the face) through the forehead can safely treat migraines during pregnancy. Since many migraine medications are not safe to use during pregnancy, this non-drug approach could offer an alternative. **You may be eligible if...** - You are between 18 and 44 years old - You are pregnant with a single baby - You have a history of headaches or migraines that started before pregnancy and continue into pregnancy, or that began during the first trimester - You have internet and smartphone access for remote check-ins - You can provide proof of your pregnancy (e.g., ultrasound, beta-hCG lab result, or a doctor's note) **You may NOT be eligible if...** - You are carrying more than one baby - Your headaches began after the first trimester of pregnancy - You are unable to use a smartphone or computer - You cannot provide documentation confirming your pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEexternal 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.

Locations(1)

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

Darien, Connecticut, United States

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NCT06788977