NCT06788977 · Cefaly Technology
External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
external Trigeminal Nerve Stimulation
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.
Primary outcome measures
Rate of miscarriage per trimester
Time frame: through study completion average 2 years
Postpartum Bonding according to the Maternal-to-Infant Bonding Scale
Time frame: through study completion average 2 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
- Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator
- No access to email, smartphone, or computer with internet access
Where
- Darien, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations