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Could a headband ease migraines in pregnancy? new registry aims to find out

NCT ID NCT06788977

Knowledge-focused Sponsor: Cefaly Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This online registry is studying the safety and effectiveness of the CEFALY device, a non-invasive nerve stimulator worn on the forehead, for treating migraines during and after pregnancy. Pregnant women aged 18-44 with migraines can join, regardless of whether they use the device or other treatments. Participants complete up to six online surveys over 12 months, with no clinic visits required.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
external trigeminal nerve stimulation (CEFALY device)
What this could lead to
If successful, this registry could provide evidence that CEFALY is a safe, drug-free option for managing migraines during pregnancy.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be limited by self-reporting and participant drop-out.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All participants in the registry should be (1) age 18-44 years, (2) pregnant with one fetus/baby at the time of enrollment (3) experience migraines or headaches during pregnancy or at the time of enrollment and (4) have access to email and text messages to receive notifications and reminders for registry surveys.

Ages

18 to 44 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients willing and able to provide simple consent for registry participation. 2. Has access to email, text messages via smartphone or computer with internet access 3. Be between the ages of 18 to 44 years at enrollment. 4. Pregnant with one fetus/baby at time of enrollment (singleton pregnancy) 5. Have headaches or migraines prior to pregnancy and continued to have headaches or migraines into pregnancy OR headaches or migraines began while pregnant in the first trimester. 6. Able to provide proof of active intrauterine pregnancy and estimated due date, via online document upload, using any of the following documents: 1. ultrasound report of current pregnancy 2. beta hcg lab report 3. a signed provider's medical documentation confirming intrauterine pregnancy with fetal heart sounds and estimated due date 4. a signed provider's note on a prescription sheet or physician letterhead confirming intrauterine pregnancy and estimated due date Exclusion Criteria: 1. Patients under the age of 18 or over the age of 44 at enrollment 2. Not pregnant at time of enrollment 3. Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy) 4. Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator 5. No access to email, smartphone, or computer with internet access

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder Headache headache disorder migraine disorder puerperal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Depression Headache Migraine Postpartum Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Darien, Connecticut, 06820, United States

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