NCT06788977 External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
| NCT ID | NCT06788977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cefaly Technology |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2024-11-25 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 document upload, using any of the following documents: 1. ultrasound report of current pregnancy 2. beta hcg lab report 3. a signed provider's medical documentation confirming intrauterine pregnancy with fetal heart sounds and estimated due date 4. a signed provider's note on a prescription sheet or physician letterhead confirming intrauterine pregnancy and estimated due date Exclusion Criteria: 1. Patients under the age of 18 or over the age of 44 at enrollment 2. Not pregnant at time of enrollment 3. Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy) 4. Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator 5. No access to email, smartphone, or computer with internet access
Contact & Investigator
Deena Kuruvilla, MD
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT06788977 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06788977 currently recruiting?
Yes, NCT06788977 is actively recruiting participants. Contact the research team at Clinicaltrial@cefaly.com for enrollment information.
Where is the NCT06788977 trial being conducted?
This trial is being conducted at Darien, United States.
Who is sponsoring the NCT06788977 clinical trial?
NCT06788977 is sponsored by Cefaly Technology. The principal investigator is Deena Kuruvilla, MD. The trial plans to enroll 550 participants.