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Can a smart armband take the sting out of migraine shots?

NCT ID NCT05730556

Symptom relief Sponsor: Mayo Clinic 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a wearable armband called Nerivio that uses mild electrical pulses to reduce pain from Botox injections in people with chronic migraine. About 80 participants were planned, but the study was stopped early. The goal was to see if the device could make the injection process less painful.

What this could mean

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

Active substance
Nerivio (remote electrical neuromodulation device)
What this could lead to
If it worked, this device could offer a drug-free way to reduce pain during migraine injection procedures.
What could go wrong
The study was terminated early, so we have little data. It was also small (80 people) and only looked at short-term pain relief during injections.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria. * Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine. * Patient is willing and able to comply with the protocol to the satisfaction of the investigator. * Patient has the capacity to provide written, informed consent for themselves. Exclusion Criteria: * Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant). * Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease. * Participants with uncontrolled epilepsy. * Pregnant, trying to get pregnant or breastfeeding female participants. * Subjects participating in any other interventional clinical study. * Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments. * Participants who have previous experience with the device. * Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement. * Patients receiving concurrent nerve blocks or trigger point injections within the same visit

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Chronic migraine

Contacts and locations

Locations

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.