Health Trials

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • external Trigeminal Nerve Stimulation

Treatment groups

550 Participants
are divided into 2 treatment groups

Locations

1
https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true06820, DarienConnecticut, United States

Sponsors and collaborators

Cefaly Technology

Lead sponsor

Source ClinicalTrials.gov