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.
GBD 2019 Diseases and Injuries Collaborators
https://pubmed.ncbi.nlm.nih.gov/33069326/Actively Recruiting
Led by Cefaly Technology · Updated on 2026-04-15
550
Participants Needed
1
Research Sites
191 weeks
Total Duration
Researchers are conducting a prospective online registry to explore the potential benefits and safety of external trigeminal nerve stimulation eTNS for treating migraines in pregnant women. The registry includes women with migraines or headaches who are pregnant, whether or not they use the eTNS device. The main goal is to determine if eTNS is a safe and effective option for migraine treatment during and after pregnancy. Participants are divided into two groups those who use the eTNS device during pregnancy and those who do not. Use of the device is not required to join the registry, and participants may start or stop using eTNS at any time without affecting their participation. The registry collects information entirely online through surveys completed at specific pregnancy and postpartum time points, including pre-pregnancy, each trimester, and early and late postpartum periods. Women enrolled will complete up to six surveys over about 12 months, covering health history, migraine symptoms, treatments, and mental health impacts. Participants using eTNS will answer additional questions about device use. Surveys are sent via email and text, with identity verification to protect data. The registry measures outcomes like the rate of miscarriage and postpartum bonding, with overall participation time estimated between 60 and 90 minutes.
CONDITIONS
External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
M
Michael A.L. Johnson, MD
G
Gregory Panza, PhD
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Cefaly Technology
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Online screening and enrollment visit
Duration - From enrollment through late postpartum (up to approximately 1 year after childbirth)
Participants complete up to six surveys over the course of their pregnancy and postpartum period to provide information about their health history, migraine symptoms, and treatments.
Surveys sent via email and SMS at baseline, first, second, and third trimesters, and early and late postpartum
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23992560/Cefaly Technology
Lead Sponsor