External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

NCT06788977 | Recruiting FDA Device

• 1 other identifier: 51001
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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

Migraine; Headache; Postpartum; Depression; Anxiety; Pregnancy

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

Outcome Measures

Primary Outcomes (2)

• Rate of miscarriage per trimester

  through study completion average 2 years

• Postpartum Bonding according to the Maternal-to-Infant Bonding Scale

  The "Maternal-to-Infant Bonding Scale" is a scale which measures the mother's feelings regarding her child within the first few weeks after birth. The score of teh scale can range from 0 which denotes favorable or good outcome whereas the maximum score is 24 indicating a poor outcome.

  through study completion average 2 years

Study Arms (2)

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.

Device: external Trigeminal Nerve Stimulation

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 DEVICE

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.

Also known as: supraorbital transcutaneous stimulator (STS)

External Trigeminal Nerve Stimulation (eTNS) group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All participants in the registry should be (1) age 18-44 years, (2) pregnant with one fetus/baby at the time of enrollment (3) experience migraines or headaches during pregnancy or at the time of enrollment and (4) have access to email and text messages to receive notifications and reminders for registry surveys.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (1)

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

Darien, Connecticut, 06820, United States

RECRUITING

Related Publications (12)

• Nappi RE, Tiranini L, Sacco S, De Matteis E, De Icco R, Tassorelli C. Role of Estrogens in Menstrual Migraine. Cells. 2022 Apr 15;11(8):1355. doi: 10.3390/cells11081355.

  PMID: 35456034 BACKGROUND

• Skajaa N, Szepligeti SK, Xue F, Sorensen HT, Ehrenstein V, Eisele O, Adelborg K. Pregnancy, Birth, Neonatal, and Postnatal Neurological Outcomes After Pregnancy With Migraine. Headache. 2019 Jun;59(6):869-879. doi: 10.1111/head.13536. Epub 2019 May 8.

  PMID: 31069791 BACKGROUND

• Frederick IO, Qiu C, Enquobahrie DA, Aurora SK, Peterlin BL, Gelaye B, Williams MA. Lifetime prevalence and correlates of migraine among women in a pacific northwest pregnancy cohort study. Headache. 2014 Apr;54(4):675-85. doi: 10.1111/head.12206. Epub 2013 Aug 28.

  PMID: 23992560 BACKGROUND

• Welander NZ, Mwinyi J, Asif S, Schioth HB, Skalkidou A, Fransson E. Migraine as a risk factor for mixed symptoms of peripartum depression and anxiety in late pregnancy: A prospective cohort study. J Affect Disord. 2021 Dec 1;295:733-739. doi: 10.1016/j.jad.2021.08.119. Epub 2021 Sep 4.

  PMID: 34517247 BACKGROUND

• Friedman LE, Aponte C, Perez Hernandez R, Velez JC, Gelaye B, Sanchez SE, Williams MA, Peterlin BL. Migraine and the risk of post-traumatic stress disorder among a cohort of pregnant women. J Headache Pain. 2017 Dec;18(1):67. doi: 10.1186/s10194-017-0775-5. Epub 2017 Jul 6.

  PMID: 28685258 BACKGROUND

• Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.

  PMID: 35332216 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.

  PMID: 26719105 BACKGROUND

• Wood ME, Burch RC, Hernandez-Diaz S. Polypharmacy and comorbidities during pregnancy in a cohort of women with migraine. Cephalalgia. 2021 Mar;41(3):392-403. doi: 10.1177/0333102420975394. Epub 2020 Dec 3.

  PMID: 33269942 BACKGROUND

• Burch R. Epidemiology and Treatment of Menstrual Migraine and Migraine During Pregnancy and Lactation: A Narrative Review. Headache. 2020 Jan;60(1):200-216. doi: 10.1111/head.13665. Epub 2019 Oct 3.

  PMID: 31579938 BACKGROUND

• GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

  PMID: 33069326 BACKGROUND

Related Links

• Headaches.com

MeSH Terms

Conditions

Migraine Disorders; Headache; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Deena Kuruvilla, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A.L. Johnson, MD

CONTACT

203-309-3776; Clinicaltrial@cefaly.com

Gregory Panza, PhD

CONTACT

203-309-3776; Clinicaltrial@cefaly.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 23, 2025
• Study Start: November 25, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)