Trials / Completed

CompletedNCT05464069

Safety of Nerivio in Pregnant Women With Migraine

A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum

Status: Completed
Phase: —
Study type: Observational
Enrollment: 145 (actual)

Sponsor: Theranica · Industry
Sex: Female
Age: 18 Years – 42 Years
Healthy volunteers: Accepted

Summary

Detailed description

This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group). Study group: Study group participants will be recruited from Nerivio's user base. An invitation message will be sent via in-app notification and/or email to all Nerivio users who are (1) female, AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st, 2021. Users who meet these criteria will be invited to fill in a screening and eligibility questionnaire. If they meet the eligibility criteria, they will be offered the opportunity to participate in the study. Participants will complete and sign an electronic informed consent form. Following consent, participants will be asked to complete the questionnaire. Once complete, participants will be compensated for their time. Control group: Control group participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period. Patients interested in participating will be directed to the same screening and eligibility questionnaire and will follow the same study design. Endpoints focus on the health of the mother and the baby, during pregnancy and three months postpartum. Primary endpoint: Demonstrate that the study group is not different than the control group in regard to gestational age at delivery (measured in pregnancy weeks). Secondary endpoints: Demonstrate that the study group is not different from the control group in: 1. Baby's birth weight (average birth weight) 2. Miscarriage rate (% of miscarriage cases) 3. Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy weeks less than 37) 4. Birth deficits rate (% of birth deficits) 5. Still births rate (% of still births) 6. Meeting developmental milestones following 3 months postnatal (% of babies) 7. Visits to the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period (# of events)

Conditions

Interventions

Type	Name	Description
DEVICE	Nerivio	Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application
DRUG	Migraine Relief	Any drug for treatment of migraine relief

Timeline

Start date: 2022-08-01
Primary completion: 2022-11-28
Completion: 2022-12-07
First posted: 2022-07-19
Last updated: 2025-10-06
Results posted: 2025-10-06

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05464069. Inclusion in this directory is not an endorsement.