Online registry on a migraine device device during pregnancy
Follows pregnant women with migraine who may use a nerve-stimulation device.
Key facts
- Who runs it
- Cefaly Technology
- Where
- Darien, United StatesSee the site
- Trial code
- Registry title
- External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
- Status
- Recruiting
- People taking part
- 550 people, planned
- Started
- 25 Nov 2024
- Expected to end
- Dec 2030
- Type of study
- Observational, 2 groups
- Treatments tested
- external Trigeminal Nerve Stimulation
- Record updated
- 15 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 44 who are pregnant with one baby and have headaches or migraines. It is an online registry with surveys only.
- Age
- 18 to 44 years
- Sex
- Women only
- Disease stage
- Pregnant with one baby (singleton pregnancy). Headaches or migraines that started before pregnancy and continued, or began in the first trimester.
- Earlier treatment
- No change in treatment is required. Women can use external trigeminal nerve stimulation or any other migraine treatment, or none.
Main reasons for not taking part
- Under 18 or over 44 years old at enrollment
- Not pregnant at enrollment
- Pregnant with more than one baby
- No access to email, smartphone or a computer with internet
- Any other condition that the doctor or study investigator thinks would prevent taking part
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant with one fetus/baby at time of enrollment (singleton pregnancy)
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Patients willing and able to provide simple consent for registry participation
- Has access to email, text messages via smartphone or computer with internet access
- Be between the ages of 18 to 44 years at enrollment
- Pregnant with one fetus/baby at time of enrollment (singleton pregnancy)
- 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
- Able to provide proof of active intrauterine pregnancy and estimated due date, via online document upload, using any of the following documents:; ultrasound report of current pregnancy; beta hcg lab report; a signed provider's medical documentation confirming intrauterine pregnancy with fetal heart sounds and estimated due date; a signed provider's note on a prescription sheet or physician letterhead confirming intrauterine pregnancy and estimated due date
Who cannot take part
- Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator
- Patients under the age of 18 or over the age of 44 at enrollment
- Not pregnant at time of enrollment
- Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy)
- No access to email, smartphone, or computer with internet access
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 44 years old?
Where in United States
- Darien, ConnecticutHospital not named in the registryContact: Lilliana DelmonicoTaking people
About the trial
What the trial wants to find out
This online registry aims to understand the potential benefits and safety of external trigeminal nerve stimulation for the treatment of migraine in pregnant women. Women do not need to use external trigeminal nerve stimulation or any other form of migraine treatment to participate in the registry.
Read full original descriptionShow less
The main question it aims to answer is:
Is external trigeminal nerve stimulation a safe and effective option for migraine treatment during and after pregnancy?
There are no required changes in migraine treatment to participate in this registry. Participants may or may not use external trigeminal nerve stimulation or any other treatment they currently use and may still participate in the registry. There are no clinic or research visits, as the registry is entirely online. Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months.
The 2 groups in the trial
- External Trigeminal Nerve Stimulation (eTNS) group
This group reflects participants who are already using eTNS therapy during the pregnancy, as well as participants who start using eTNS therapy at any point during their pregnancy. Any participant may opt to continue or discontinue eTNS treatments during the registry period, which will not affect their ability to participate.
Treatment: external Trigeminal Nerve Stimulation
- Non-eTNS group
This group reflects participants who have not used eTNS therapy during and throughout their pregnancy. If a participant who initially does not use eTNS therapy during pregnancy decides to start eTNS therapy at any point during their pregnancy, they will be assigned to the eTNS group.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CEFALY Pregnancy Registry
- Plain-language title
- Online registry on a migraine device device during pregnancyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06788977, who can take part
- Record updated
- 15 April 2026