Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia
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
Run by Theranica · NCT07841509 · Data updated 2026-11-12
We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Theranica Industry-sponsored |
| Locations | 2 sites (Bridgewater, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | August 1, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07841509 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with migraine and/or fibromyalgia, naïve to Nerivio for FM, and meeting specific diagnostic and stability criteria.
✕Probably not a fit
Individuals with implanted electrical devices or those not meeting stability criteria may not experience benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study uses a randomized design to see if remote electrical neuromodulation (REN) can induce conditioned pain modulation (CPM) in people with migraine or fibromyalgia. Participants will receive REN or a placebo device that looks the same but delivers a different electrical pattern, and pain responses will be measured with heat stimuli and a cold-water task. Pain intensity will be recorded on an 0-10 scale to compare responses after treatment. The approach explores a biomarker of central pain inhibition and its potential to improve pain control in these conditions. The Nerivio device is intended for home use and is controlled via a smartphone app.
Why it matters
Potential benefit: If successful, REN could enhance endogenous pain control and potentially reduce pain for people with migraine or fibromyalgia.
How similar studies have gone: Previous work has shown that similar neuromodulation approaches can influence pain pathways, but the CPM-specific effect with REN is being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Rambam Health Care Campus
Haifa, Israel Recruiting -
Theranica Bio-Electronics Inc
Bridgewater, New Jersey, United States Not yet recruiting
Study contacts
- Study coordinator: Dagan Harris, PhD
- Email: daganh@theranica.com
- Phone: +972723909763
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.