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External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

NCT06788977 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Cefaly Technology

    lead INDUSTRY

Principal Investigators

  • Deena Kuruvilla, MD

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2027-04-30
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788977 on ClinicalTrials.gov