CEFALY Pregnancy Registry

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true
RECRUITING
Darien
Contact Information
Primary
Michael A.L. Johnson, MD
Clinicaltrial@cefaly.com
203-309-3776
Backup
Gregory Panza, PhD
Clinicaltrial@cefaly.com
203-309-3776
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2030-12
Participants
Target number of participants: 550
Treatments
External Trigeminal Nerve Stimulation (eTNS) group
This group reflects participants who are already using eTNS therapy during the pregnancy, as well as participants who start using eTNS therapy at any point during their pregnancy.~Any participant may opt to continue or discontinue eTNS treatments during the registry period, which will not affect their ability to participate.
Non-eTNS group
This group reflects participants who have not used eTNS therapy during and throughout their pregnancy. If a participant who initially does not use eTNS therapy during pregnancy decides to start eTNS therapy at any point during their pregnancy, they will be assigned to the eTNS group.
Related Therapeutic Areas
Sponsors
Leads: Cefaly Technology

This content was sourced from clinicaltrials.gov