Using external trigeminal nerve stimulation to treat migraines in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Clinicaltrial@cefaly.com
• Phone: 203-309-3776

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.