Using external trigeminal nerve stimulation to treat migraines in pregnant women

CEFALY Pregnancy Registry

This study is trying to see if a device that stimulates a nerve in the face can safely help pregnant women with migraines feel better.

Quick facts

• Study type: Observational
• Enrollment: 550 (estimated)
• Ages: 18 Years to 44 Years
• Sex: Female
• Sponsor: Cefaly Technology (industry)
• Locations: 1 site (Darien, Connecticut)
• Trial ID: NCT06788977 on ClinicalTrials.gov

What this trial studies

This online registry aims to evaluate the safety and effectiveness of external trigeminal nerve stimulation for treating migraines in pregnant women. Participants can be in any trimester of pregnancy and do not need to use the stimulation device to join. The registry will collect data through up to six online surveys over a period of 12 months, focusing on women who have experienced migraines before or during pregnancy. The goal is to gather insights that could inform future treatment options for this population.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 to 44 who have a history of migraines or headaches.

Not a fit: Patients who are not pregnant or those who do not have a history of migraines or headaches may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a safe and effective treatment option for managing migraines in pregnant women.

How similar studies have performed: While the approach of using external trigeminal nerve stimulation is being explored, this specific application in pregnant women is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Darien, Connecticut

• https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true — Darien, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Deena Kuruvilla, MD
• Study coordinator: Michael A.L. Johnson, MD

Conditions: Pregnancy, Migraine, Headache, Postpartum, Depression, Anxiety, Neuromodulation, Trigeminal Nerve Stimulation