External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

Launched by CEFALY TECHNOLOGY · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called external trigeminal nerve stimulation to see if it can help pregnant women who suffer from migraines. The goal is to find out if this method is safe and effective for managing migraines during and after pregnancy. Women who have had migraines before getting pregnant or who started experiencing them during their first trimester may be eligible to join the study. Importantly, you don’t need to use this treatment or change your current migraine management to participate.

If you decide to join, you’ll complete a series of up to six online surveys, each lasting about 15-20 minutes, over the course of a year. There are no in-person visits required, making it easy to participate from home. To be eligible, you need to be between 18 and 44 years old, have a single baby on the way, and have access to the internet through a smartphone or computer. This study is a great opportunity to contribute to research that could improve migraine treatments for pregnant women, and your participation will help gather important information without any added burden.

Gender

FEMALE

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