Recruiting

External Trigeminal Nerve Stimulation

Sponsor:

Cefaly Technology

Code:

NCT06788977

Conditions

Pregnancy

Migraine

Headache

Postpartum

Depression

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

external Trigeminal Nerve Stimulation

Study Details

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.

Conditions

Pregnancy

Migraine

Headache

Postpartum

Depression

Study ID

NCT06788977

Start date

Nov 25, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

external 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.

Primary outcome measure

  • Rate of miscarriage per trimester [ Time Frame: through study completion average 2 years ]
  • Postpartum Bonding according to the Maternal-to-Infant Bonding Scale [ Time Frame: through study completion average 2 years ]

Central Contacts and Locations

Central contacts

Locations

https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true

Recruiting

Darien, Connecticut, United States, 06820

Contacts

More Information

Sponsor

Cefaly Technology

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Pregnancy
  • Migraine
  • Headache
  • Neuromodulation
  • Trigeminal Nerve Stimulation
  • External Trigeminal Nerve Stimulation
  • Postpartum
  • drug-free
  • medications
  • complementary therapy
  • alternative therapy
  • wholistic therapy
  • natural
  • non-invasive device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cefaly Technology on 2026-04-15.