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Wearable arm device and the body's pain control in migraine and fibromyalgia

Tests a wearable nerve-stimulation device against a sham device in adults with migraine or fibromyalgia.

Key facts

Who runs it
Theranica
Where
Haifa, IsraelSee the siteAlso in 1 other country, 1 site
Trial code
Registry title
The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia
Status
Recruiting
People taking part
120 people, planned
Started
23 Jun 2026
Expected to end
31 Aug 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Remote Electrical Neuromodulation (REN) device
Record updated
25 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with migraine or fibromyalgia. It tests whether a wearable arm device (REN) changes how the body inhibits pain.

Age
Above 18 years old.
Sex
All sexes can join.
Disease stage
Migraine: diagnosed by ICHD-3 criteria, with 6-24 headache days per month. Fibromyalgia: diagnosed by ACR 2010/6 criteria, with the disease for at least 6 months.
Earlier treatment
Migraine: up to 1 prescribed preventive medication. No changes to migraine or fibromyalgia medication in the month before joining. Must not have used the Nerivio device before.

Main reasons for not taking part

  • Implanted electrical or neurostimulation device, such as a pacemaker
  • Severe depression
  • Known epilepsy
  • Any painkiller in the 24 hours before joining; cannabis in the 10 days before; opioids in the 2 months before
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Pregnant or breastfeeding

Where in Israel

Also in 1 other country, 1 site

  • Rambam Health Care CampusHaifa, IsraelContact: Yelena Granovsky, PhDTaking people

About the trial

What the trial wants to find out

Migraine and Fibromyalgia (FM) are chronic pain disorders characterized by altered central pain processing and impaired endogenous pain inhibition. FM presents with widespread musculoskeletal pain, fatigue, sleep disturbance, and cognitive symptoms and is strongly associated with central sensitization. Migraine similarly involves dysfunction of central inhibitory and descending pain modulation, with evidence of abnormal cortical excitability, impaired sensory habituation, and alterations in pain-related evoked potentials.

Read full original descriptionShow less

Conditioned Pain Modulation (CPM) is a measure of the body's endogenous pain-inhibitory mechanism, based on the phenomenon whereby the pain evoked by one painful stimulus (the test stimulus) is reduced by the concurrent application of a second, remote nociceptive stimulus (the conditioning stimulus). It is widely regarded as a proxy for the function of descending pain-modulatory pathways.

CPM is used as an experimental biomarker of descending pain inhibition across chronic pain conditions, including fibromyalgia and migraine. Studies consistently demonstrate reduced inhibitory responses in both migraine and fibromyalgia compared with healthy controls, indicating a robust deficit in descending pain modulatory systems. Combining a contact heat test stimulus (TS) with a cold pressor conditioning stimulus (CS) is a widely used and validated CPM paradigm.

Nerivio, a Remote Electrical Neuromodulation (REN) device, is a non-invasive, non-pharmacological therapy indicated for the acute and preventive treatment of migraine. The REN device is worn on the upper arm and delivers peripheral electrical stimulation to activate CPM-related descending inhibitory pathways and reduce migraine pain. This distal stimulation approach is designed to activate CPM-related circuits by recruiting brainstem pain-regulatory centers and modulating central nociceptive processing.

This randomized, double-blind, placebo-controlled trial is designed to assess the effect of a single REN session on CPM and cortical pain processing in adults with migraine or fibromyalgia. Using a standardized CPM induction protocol, the study will evaluate changes in behavioral CPM responses, before, during, and after REN vs. sham stimulation in patients with migraine or fibromyalgia. This study aims to clarify whether REN enhances descending pain inhibition and pain processing in populations with impaired endogenous pain modulation.

The 2 groups in the trial

  • Active REN treatmentExisting treatment, for comparison

    This arm will use the active REN device as the Conditioned Stimulus (CS) to the thermal Test Stimulus (TS) that will be applied at 20, 40, and 60 minutes following the initiation of the treatment with the Active REN device.

    Treatment: Remote Electrical Neuromodulation (REN) device

  • Placebo REN treatmentPlacebo, for comparison

    This arm will use the Placebo device as the Conditioned Stimulus (CS) to the thermal Test Stimulus (TS) that will be applied at 20, 40, and 60 minutes following the initiation of the treatment with the Placebo device.

    Treatment: Remote Electrical Neuromodulation (REN) device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Effect of a REN Wearable Device on Conditioned Pain Modulation (CPM) in Patients With Migraine and/or Fibromyalgia
Plain-language title
Wearable arm device and the body's pain control in migraine and fibromyalgiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 September 2026