An observational study in Pregnancy, Migraine and Headache, sponsored by Cefaly Technology. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Cefaly Technology · Observational
Among 696 studies in Migraine Disorders with a site in United States — 93 open to participants now, 115 under way, 27 of them phase 3. Migraine Disorders · United States.
Among the 696 studies in Migraine Disorders with a site in United States, this one is the 23rd largest by planned enrollment of the 84 observational ones that give a count, is one of 39 that started in 2024, is one of 85 observational ones, reaches primary completion later than 42 of the 114 other live ones, and was the 627th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →93 of the 696 studies in Migraine Disorders with a site in United States are open now. Recruiting first, the newest first:
Salvia BioElectronics · Sites in United States
Ages 22–84
University of Colorado, Denver · Sites in United States
Ages 12–17
Columbia University · Sites in United States
Ages 18–55
TriGemX Bio, Inc. · Sites in United States
Ages 18–75
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 44 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
696 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 66 · Phase 2 113 · Phase 3 151 · Phase 4 101
First in 1999; this study’s year is marked. 39 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 550 is above the median of 137 across 331 observational studies indexed under Migraine Disorders.
Median enrollment 78 across the 609 interventional studies, 195 across the 84 observational. Of the 526 that completed or were terminated, 305 (58%) have results posted.
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344 of 696 have an industry lead sponsor. The 10 most frequent:
Cefaly Technology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Cefaly Technology has 7 studies filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
47 of the studies in Migraine Disorders with a site in United States that are under way reach primary completion within a year, 11 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07645924Phase 3TriGemX Bio, Inc.A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine | 2027-02 |
| NCT05598723Phase 3Naval Medical Center Camp LejeuneBOTOX® vs. XEOMIN® for Chronic Migraine | 2027-02-24 |
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
Add all 47 to your calendar (.ics) → With an account.
Among the 696 studies in Migraine Disorders with a site in United States, from their registry updates:
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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.
This will be a prospective research registry from which retrospective research studies will derive. Individuals who are eligible to participate in the CEFALY Pregnancy Registry will be pregnant women who have migraines or headaches. Use of the external Trigeminal Neurostimulation (eTNS) device is not mandatory for participation in the registry, and the registry will include information from individuals who use and do not use eTNS (CEFALY) to treat their migraines or headaches before, during, and after pregnancy.
The ideal candidate for participation will be women within 14 weeks gestation at the time of screening enrollment, as this will minimize any recall bias. However, women in the second and third trimesters during screening and enrollment will not be excluded and may also participate in the registry. The registry will aim to enroll 550 participants per the inclusion and exclusion criteria.
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. Once the simple consent is acknowledged, the potential participant will enter their name, email, phone number and date of birth. The phone number, and email entered are required to conduct the registry data collection process.
Participants will then complete screening questions to assess their eligibility for the registry. If they meet all eligibility requirements, they will be required to upload sufficient evidence of a current intrauterine pregnancy. The registry investigators will verify the uploaded document for accuracy before enrollment. The participant's name and date of birth are required to validate a current pregnancy based on the required uploaded documents during the screening process.
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. The links provided in the email and SMS text will automatically direct the participant to the appropriate survey based on the timing of their enrollment, estimated due date, pregnancy status, and date of completion of prior surveys. 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.
In general, the surveys will ask questions about the participant's health history, their previous pregnancies (if applicable), current pregnancy, migraine or headache symptoms and migraine treatments and therapies. In addition, participants will be asked to complete several validated scales assessing the degree of migraine disability and mental health impact. If the participant indicates that they are using eTNS CEFALY during the registry process, they will also receive surveys about their eTNS use. Any unclear survey responses are found during periodic reviews as part of data quality assurance. In that case, study staff may contact the participant via email and/or phone call to clarify an answer or answers on the survey.
In most circumstances, the registry participants will be asked to complete up to six surveys. Based on preliminary registry testing, the enrollment (consent and screening) and baseline period will take participants approximately 20 minutes to complete. The five sets of surveys (1st, 2nd, 3rd trimester, early postpartum, and late postpartum) will take approximately 10 - 15 minutes for each participant to complete. Therefore, we estimate that the total participation time for most participants will be between 60 and 90 minutes. In some situations, the timing and number of surveys and time points requested will differ for some participants based on their responses.
A link to a survey will be sent to the participant's email and phone via text for each of the following time points as indicated by the patient's estimated due date at time of enrollment.
Pre-pregnancy and Baseline: This survey will be sent following registry enrollment First trimester: This survey will be sent at 14 weeks gestation Second trimester: This survey will be sent at 28 weeks gestation Third trimester: This survey will be sent at 37 weeks gestation. Early postpartum: This survey will be sent 6 weeks following childbirth Late postpartum: This survey will be sent 12 weeks following childbirth
If the participant enrolls in the registry beyond any of the gestation periods described above, they will also be asked to complete the baseline and earlier trimester surveys before their current trimester following registry enrollment. If the participant delivers before 37 weeks gestation, the third-trimester survey will be sent following notification of childbirth.
All participants in the registry should be (1) age 18-44 years, (2) pregnant with one fetus/baby at the time of enrollment (3) experience migraines or headaches during pregnancy or at the time of enrollment and (4) have access to email and text messages to receive notifications and reminders for registry surveys.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to provide proof of active intrauterine pregnancy and estimated due date, via online document upload, using any of the following documents:
Exclusion Criteria:
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.
Device: external Trigeminal Nerve Stimulation
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.
External trigeminal nerve stimulation (e-TNS) is a non-invasive, nondrug option for the acute and preventative treatment of migraine. The device is marketed under the trade name CEFALY and has received clearance from the US Food and Drug Administration (FDA) for the acute and preventative treatment of migraine. The CEFALY device provides transcutaneous stimulation of the supraorbital and supratrochlear branches of the ophthalmic division of the Trigeminal nerve. Patients apply a self-adhesive electrode pad to their forehead, then place the CEFALY generator over the electrodes, resulting in a magnetic connection. The user then selects a treatment program for acute or preventative therapy, which lasts for 60 or 20 minutes.
Also known as: supraorbital transcutaneous stimulator (STS)
Rate of miscarriage per trimester
Time frame: through study completion average 2 years
Postpartum Bonding according to the Maternal-to-Infant Bonding Scale
The "Maternal-to-Infant Bonding Scale" is a scale which measures the mother's feelings regarding her child within the first few weeks after birth. The score of teh scale can range from 0 which denotes favorable or good outcome whereas the maximum score is 24 indicating a poor outcome.
Time frame: through study completion average 2 years
Plan to share: No — Given the potentially sensitive nature of the information collected within the registry, IPD will not be shared to protect participants' information as much as possible.
Started Nov 2024 (actual). Primary completion is estimated for Apr 2027, 29 months after the start.
Of 160 observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Cefaly Technology