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

1

Research Sites

191 weeks

Total Duration

On this page

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

Eligible

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)
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Online screening and enrollment visit

Monitoring

Duration - From enrollment through late postpartum (up to approximately 1 year after childbirth)

Participants complete up to six surveys over the course of their pregnancy and postpartum period to provide information about their health history, migraine symptoms, and treatments.

Surveys sent via email and SMS at baseline, first, second, and third trimesters, and early and late postpartum

Trial Site Locations

Total: 1 location

1

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

Darien, Connecticut, United States, 06820

Actively Recruiting

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Research Team

M

Michael A.L. Johnson, MD

G

Gregory Panza, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Lifetime prevalence and correlates of migraine among women in a pacific northwest pregnancy cohort study.

Ihunnaya O Frederick, Chunfang Qiu, Daniel A Enquobahrie...

https://pubmed.ncbi.nlm.nih.gov/23992560

Migraine as a risk factor for mixed symptoms of peripartum depression and anxiety in late pregnancy: A prospective cohort study.

Nike Zoe Welander, Jessica Mwinyi, Sana Asif...

https://pubmed.ncbi.nlm.nih.gov/34517247

Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM).

Deena E Kuruvilla, Joseph I Mann, Stewart J Tepper...

https://pubmed.ncbi.nlm.nih.gov/35332216