Safety of Nerivio in Pregnant Women With Migraine

NCT05464069 | Completed Results FDA Device

• 1 other identifier: TCH011
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 2

Brief Summary

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). Nerivio group participants will be recruited from Theranica's user base. Control group participants will be recruited by health care providers, including headache specialists and OBGYNs (study co-investigators). The study is based on an e-Survey including an e-eligibility questionnaire, an e-ICF ande-Questionnaire. Participants will be compensated for their time.

Conditions

Migraine; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Gestational Age at Delivery

  The mean number of gestational age at delivery in both study groups (measured in pregnancy days).

  Retrospective Data for up to 42 weeks, collected over 2 months

Secondary Outcomes (7)

• Birth Weight

  Retrospective Data for up to 42 weeks, collected over 2 months

• Miscarriage Rate

  Retrospective Data for up to 42 weeks, collected over 2 months

• Preterm Birth Rate

  Retrospective Data for up to 42 weeks, collected over 2 months

• Birth Deficits Rate

  Retrospective Data for up to 42 weeks, collected over 2 months

• Still Births Rate

  Retrospective Data for up to 42 weeks, collected over 2 months

Study Arms (2)

Postpartum females with migraine who used Nerivio during their pregnancy

Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database

Device: Nerivio

Postpartum females with migraine who used other migraine therapy during their pregnancy

Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. 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

Drug: Migraine Relief

Interventions

Nerivio DEVICE

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

Also known as: Neriivo

Postpartum females with migraine who used Nerivio during their pregnancy

Migraine Relief DRUG

Any drug for treatment of migraine relief

Also known as: migraine treatment

Postpartum females with migraine who used other migraine therapy during their pregnancy

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Postpartum women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."

You may qualify if:

• Diagnosed with migraine
• History of migraine pre-pregnancy with an average of at least 4 migraine days per month, in the six months prior to the last pregnancy
• History of pregnancy with last menstrual period (LMP) between November 1st, 2019 - March 31st, 2021. Pregnancy within this time window is the pregnancy of study, termed "study pregnancy"
• Between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy"
• History of at least 4 migraine attacks during "study pregnancy"
• In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during "study pregnancy"
• In the control group: No history of using Nerivio, ever

You may not qualify if:

• History of preterm birth (gestational age at deliver\<37 weeks) in previous pregnancies prior to the "study pregnancy"
• History of congenital malformations or birth defects in previous pregnancies prior to the "study pregnancy"
• Severe other diseases which started before the "study pregnancy" and lasted into the "study pregnancy" period, including congenital heart disease, arrhythmia, history of myocardial infarction (MI), history of stroke, or active cancer
• Serious physical injury that occurred during the "study pregnancy": severe car collision injury, serious injury at home/work, etc. Multiple gestation (i.e., pregnancy with more than one baby at a time, such as pregnancy with twins, triplets, and quadruplets) in the "study pregnancy"

Sponsors & Collaborators

• Theranica: lead

Study Sites (2)

University of California San Diego (UCSD)

San Diego, California, 92037, United States

Location

Theranica USA

Montclair, New Jersey, 07042, United States

Location

Related Publications (1)

• Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970. doi: 10.1111/head.14586. Epub 2023 Jun 19. No abstract available.

  PMID: 37335242 RESULT

Related Links

• Pubmed reference

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

1. \- The retrospective nature of the study may limit the conclusions of this survey by recall bias 2. \- The REN group included 59 patients, making it smaller than groups included in other studies assessing the efficacy and safety of migraine treatments in the general population

Results Point of Contact

• Title: Dr Dagan Harris, VP Clinical and Regulatory Affairs
• Organization: Theranica

daganh@theranica.com

+972542220121

Study Officials

• Alit Stark Inbar, PhD

  Theranica USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: August 1, 2022
• Primary Completion: November 28, 2022
• Study Completion: December 7, 2022
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)