Armband zaps may awaken the Body's own pain brakes

NCT ID NCT07841509

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether a wearable arm device can strengthen the body's natural pain-inhibition system in adults with migraine or fibromyalgia. The device, called Nerivio, delivers mild electrical stimulation to the upper arm. In this randomized, double-blind, placebo-controlled trial, 120 participants receive either the active device or a sham version. The study measures changes in conditioned pain modulation, a lab test of how well the nervous system dampens pain, before, during, and after a single session.

What this could mean

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

Active substance
a wearable device that delivers mild electrical stimulation to the upper arm (remote electrical neuromodulation)
What this could lead to
If it works, this could offer a drug-free way to turn up the body's own pain-damping system for people with migraine or fibromyalgia.
What could go wrong
This is a small, single-session study measuring a lab signal, not long-term pain relief. The device may not change that signal, and results in a controlled setting may not translate to everyday life.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

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.

Ages

18 years and older

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: \- Adults diagnosed with migraine and/or fibromyalgia above 18 years old. For migraine: * Has been diagnosed with migraine according to the ICHD-3 diagnostic criteria for migraine * Experiencing 6-24 headache days per month * Uses up to 1 prescribed preventive medication for migraine * Did not make any changes to their migraine medications treatment in the month prior to the study enrollment. For Fibromyalgia: * Has been diagnosed with FM according to the ACR 2010/6 diagnostic criteria for FM with disease duration for at least 6 months prior to study enrolment. * Did not make any changes to their FM medications in the month prior to the study enrollment. * Naïve to the Nerivio device. * Must be able and willing to comply with the protocol. * Provides written informed consent form. Exclusion Criteria: * Has an implanted electrical and/or neurostimulation device (e.g., cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, sphenopalatine ganglion stimulator bladder stimulator, or occipital nerve stimulator). * Patients with severe depression. * Patients with known epilepsy. Use of any analgesics (OTC or prescribed) 24 hours prior to the study enrollment. * Use of Cannabis within 10 days prior to the study enrollment. * Use of opioids 2 months prior to the study enrollment. * Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Israel

  • Theranica Bio-Electronics Inc

    NOT_YET_RECRUITING

    Bridgewater, New Jersey, 08807, United States

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