CEFALY Pregnancy Registry
Cefaly Technology
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.
Description
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…
Eligibility
- Age range
- 18–44 years
- Sex
- Female
- Healthy volunteers
- No
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 docu…
Interventions
- Deviceexternal 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.
Location
- https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=trueDarien, Connecticut