External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
CEFALY Pregnancy Registry
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 44 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Questionnaires, Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months."
- "Registry participation, including consent, screening, enrollment, and completion of registry surveys, will be completed online using a confidential survey platform accessed via a publicly available web-based link."
- "If eligible and documentation of current pregnancy is confirmed, the investigators will enroll the participant in the registry and start the survey process."
- "Enrolled participants who have agreed to participate in the registry will receive an invitation to the requested surveys via automated email and short message service (SMS) text."
- "Before each survey attempt, enrolled participants will need to verify their identity with an automated authentication code provided to their registered email address and phone number they provided during initial screening to verify their data and protect their entered health information."
- "If the participant indicates that they are using eTNS CEFALY during the registry process, they will also receive surveys about their eTNS use."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This online study looks at whether external trigeminal nerve stimulation, which stimulates a nerve from outside the body, is safe and helps treat migraines during and after pregnancy. It is for pregnant women ages 18 to 44 who have headaches or migraines. You do not need to use this treatment or change your care; you complete up to six 15–20-minute online surveys over up to 12 months, with no clinic visits.
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. 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are willing and able to give consent, meaning you agree to join the study.
- You have access to email and text messages through a smartphone or computer with internet access.
- You are 18 to 44 years old when you join.
- You are pregnant with one baby when you join.
- Your headaches or migraines started before pregnancy and continued during pregnancy, or started in the first trimester (the first 3 months).
- You can upload proof of a current pregnancy inside the womb and your expected due date. Accepted records include an ultrasound report, a beta hCG pregnancy blood test report, or a signed medical note confirming the pregnancy and due date.
Who can't join
- You are younger than 18 or older than 44 when you join.
- You are not pregnant when you join.
- You are pregnant with more than one baby.
- Your doctor or the study leader thinks another health condition could keep you from taking part.
- You do not have access to email, a smartphone, or a computer with internet access.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
CT
- https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true · Darien, CT 06820Lilliana Delmonico · Study contact · (475) 270-1033 · l.delmonico@cefaly.comMichael Johnson · Study contactMore trials in Darien