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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Pregnancy Related
• Intervention / Treatment: Device: Nerivio; Drug: Migraine Relief

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)

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • University of California San Diego (UCSD)
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Theranica USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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."

Description

Inclusion Criteria:

1. Diagnosed with migraine
2. 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
3. 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"
4. Between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy"
5. History of at least 4 migraine attacks during "study pregnancy"
6. In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during "study pregnancy"
7. In the control group: No history of using Nerivio, ever

Exclusion Criteria:

1. History of preterm birth (gestational age at deliver<37 weeks) in previous pregnancies prior to the "study pregnancy"
2. History of congenital malformations or birth defects in previous pregnancies prior to the "study pregnancy"
3. 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
4. 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"

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Other Names: Neriivo
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; Any drug for treatment of migraine relief; Other Names: migraine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth Weight	The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).	Retrospective Data for up to 42 weeks, collected over 2 months
Miscarriage Rate	The percent of miscarriage in both study groups	Retrospective Data for up to 42 weeks, collected over 2 months
Preterm Birth Rate	The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups	Retrospective Data for up to 42 weeks, collected over 2 months
Birth Deficits Rate	The percent of birth deficits in both study groups	Retrospective Data for up to 42 weeks, collected over 2 months
Still Births Rate	The percent of Still birth in both study groups	Retrospective Data for up to 42 weeks, collected over 2 months
Developmental Milestones Rate Following 3 Months Postnatal	The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces)	Retrospective Data for up to 55 weeks, collected over 2 months
Migraine Patterns	The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups	Retrospective Data for up to 55 weeks, collected over 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of the study group in terms of subjective assessment of safety and confidence of using migraine therapy during pregnancy	The mean score of the assessment questionnaire in both study groups	42 weeks

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Principal Investigator: Alit Stark Inbar, PhD, Theranica USA

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pubmed reference

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: TCH011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No