External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy (NCT06788977) | Clinical Trial Compass
RecruitingNot Applicable
External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
United States550 participantsStarted 2024-11-25
Plain-language 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.
Who can participate
Age range
18 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of miscarriage per trimester
Timeframe: through study completion average 2 years
2
Postpartum Bonding according to the Maternal-to-Infant Bonding Scale
Timeframe: through study completion average 2 years
. 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