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Can a Nerve-Stimulating arm band safely treat migraines in pregnant women?

NCT ID NCT05464069

Knowledge-focused Sponsor: Theranica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study surveyed 145 women with migraines who were pregnant between 2019 and 2021. It compared pregnancy and baby health between those who used the Nerivio device for migraine attacks and those who didn't. The goal was to see if using Nerivio during pregnancy is safe for both mother and child.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nerivio (a device that uses mild electrical pulses on the arm to relieve migraines)
What this could lead to
If results show no safety concerns, it may provide reassurance that Nerivio is a safe option for treating migraines during pregnancy.
What could go wrong
This is a small, retrospective survey study, not a controlled trial, so it can't prove cause and effect. Results may be biased by how participants were selected or how they reported their health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

145 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 42 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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"

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Conditions

The condition(s) this trial relates to.

migraine disorder pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine Pregnancy related

Contacts and locations

Locations

  • Theranica USA

    Montclair, New Jersey, 07042, United States

  • University of California San Diego (UCSD)

    San Diego, California, 92037, United States

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