What is this study trying to find out about migraine in pregnancy?

This study aims to understand if external trigeminal nerve stimulation (eTNS) is a safe and effective way to treat migraines during and after pregnancy. Researchers want to learn more about how this device works for pregnant women with migraines. The study is sponsored by Cefaly Technology and collects information through online surveys.

Who may be eligible for this migraine in pregnancy clinical trial?

Women aged 18 to 44 who are currently pregnant with one baby and have migraines or headaches either before or during pregnancy may be eligible. Participants need access to email and a smartphone or computer with internet. Please review eligibility criteria for more details.

Is there any cost to participate in this migraine in pregnancy clinical trial?

Study-related care, including all surveys and data collection, is provided at no cost. However, personal expenses like internet access or device usage may vary and are not guaranteed to be covered. Participation is entirely online and voluntary.

Actively Recruiting

Age: 18Years - 44Years

FEMALE

ID06788977

CEFALY Pregnancy Registry for Migraine Treatment Using External Trigeminal Nerve Stimulation in Pregnant Women

Led by Cefaly Technology · Updated on 2026-04-15

550

Participants Needed

Research Sites

191 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a prospective online registry to explore the potential benefits and safety of external trigeminal nerve stimulation eTNS for treating migraines in pregnant women. The registry includes women with migraines or headaches who are pregnant, whether or not they use the eTNS device. The main goal is to determine if eTNS is a safe and effective option for migraine treatment during and after pregnancy. Participants are divided into two groups those who use the eTNS device during pregnancy and those who do not. Use of the device is not required to join the registry, and participants may start or stop using eTNS at any time without affecting their participation. The registry collects information entirely online through surveys completed at specific pregnancy and postpartum time points, including pre-pregnancy, each trimester, and early and late postpartum periods. Women enrolled will complete up to six surveys over about 12 months, covering health history, migraine symptoms, treatments, and mental health impacts. Participants using eTNS will answer additional questions about device use. Surveys are sent via email and text, with identity verification to protect data. The registry measures outcomes like the rate of miscarriage and postpartum bonding, with overall participation time estimated between 60 and 90 minutes.

CONDITIONS

Brief Title

External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

Who Can Participate

Age: 18Years - 44Years

FEMALE

Eligibility Criteria

You may qualify if you...

Willing and able to provide consent for registry participation
Access to email and text messages via smartphone or computer with internet
Between the ages of 18 to 44 years at enrollment
Pregnant with one fetus (singleton pregnancy) at enrollment
Have headaches or migraines before pregnancy and continuing into pregnancy, or began in the first trimester
Able to provide proof of current intrauterine pregnancy and estimated due date via document upload (ultrasound report, beta hCG lab report, or signed provider's documentation)

You will not qualify if you...

Under 18 or over 44 years old at enrollment
Not pregnant at enrollment
Pregnant with more than one fetus (multigestational pregnancy) at enrollment
Presence of any other condition that may prevent participation as determined by physician or investigator
No access to email, smartphone, or computer with internet

Research Team

Michael A.L. Johnson, MD

Gregory Panza, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here