The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia

NCT ID
NCT07841509
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Theranica
Conditions
Conditioned Pain Modulation, Fibromyalgia, Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 120 participants (Estimated).

What is being studied

  • Device: Remote Electrical Neuromodulation (REN) device

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 1 is listed as Recruiting.

Countries: Israel, United States

  • New Jersey, United States: 1

Sample of listed locations

  • Rambam Health Care Campus — Haifa, Israel — Recruiting
  • Theranica Bio-Electronics Inc — Bridgewater, New Jersey, 08807, United States — Not yet recruiting

Study details

Start date
June 23, 2026
Primary completion date
August 1, 2027
Completion date
August 31, 2027
First posted
September 25, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07841509
Registry last updated
September 25, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07841509 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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