Armband zaps may awaken the Body's own pain brakes
NCT ID NCT07841509
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Conditioned pain modulation are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
2 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Rambam Health Care Campus
RECRUITINGHaifa, Israel
-
Theranica Bio-Electronics Inc
NOT_YET_RECRUITINGBridgewater, New Jersey, 08807, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Your genes may decide if fibromyalgia drug duloxetine works
- Back connective tissue under scrutiny in fibromyalgia
- Can a smartphone app help tame chronic pain?
- Can a Two-Drug migraine pill stop pain in two hours?
- Gut bacteria may hold clues to dozens of diseases
- Blood, tears and saliva: the hunt for Migraine's hidden signature