External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

NCT06788977 · tracked via the Priya Life Science USA tracker

Sponsor

Cefaly Technology

Phase

Observational

Started

2024-11-25

Last updated

2026-04-15

Condition(s) studied

PregnancyMigraineHeadachePostpartumDepressionAnxiety

Investigational drug(s) / intervention(s)

external Trigeminal Nerve Stimulation

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.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

44 Years

Healthy volunteers

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

Primary outcome measure(s)

Rate of miscarriage per trimester — through study completion average 2 years
Postpartum Bonding according to the Maternal-to-Infant Bonding Scale — 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.

Trial sites (1)

Facility	City	Region	Status
https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true	Darien	Connecticut	Recruiting

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Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) Recruiting

Probiotics for Anxiety Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06788977 on ClinicalTrials.gov ↗ ← All trials in the USA