External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
CEFALY Pregnancy Registry
Cefaly Technology
550 participants
Nov 25, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria5
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06788977