NCT07487701

Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited, especially among patients with chronic migraine. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study evaluated the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in chronic migraine population.

Detailed description

Preventive treatment options for migraine aim to reduce attack frequency, severity, and duration, as well as the overall burden of disease, with the goal of improving patients' quality of life. The 2021 AHS Consensus Statement reports that preventive treatments are used by only 3%-13% of patients with migraine, despite potential benefits for almost 40% of all migraine patients and nearly all individuals with chronic migraine (CM). Existing pharmacological treatments include several classes, such as beta-adrenergic blockers, calcium channel blockers, antiepileptic agents, tricyclic antidepressants, and therapies targeting the calcitonin gene-related peptide (CGRP) pathway, including monoclonal antibodies and small-molecule antagonists. Different studies have demonstrated that these agents can reduce monthly migraine days (MMDs) and migraine-related disability. However, their clinical use is often limited due to adverse effects, reduced effectiveness, contraindications, high cost, and poor long-term adherence, resulting in high discontinuation rates in real-world practice. Analysis from a US database including more than 8,000 patients showed that over 80% of CM patients discontinue oral preventive therapy during the first year. These limitations highlight the need for effective, well-tolerated, and adherence-friendly preventive treatment alternatives. Remote electrical neuromodulation (REN) is an FDA-cleared, non-invasive, non-pharmacologic prescribed wearable device indicated for the acute and/or preventive treatment of migraine in individuals aged 8 years and older. For acute treatment, REN is indicated for administration as early as possible at the onset of an attack to relieve pain and associated migraine symptoms. For preventive use, REN is indicated for treatment every other day to reduce migraine attack frequency. The efficacy of REN for acute treatment of migraine attacks has been demonstrated in randomized controlled trials (RCTs), open-label studies, and many real-world evidence (RWE) studies. The efficacy of migraine prevention with the REN wearable has been also shown in an RCT. Preventive benefits were also shown in adolescents with high reduction in MMDs after 3 months of REN use. This study is the first to evaluate real-world preventive use of the REN wearable device in patients with CM, a population with high disease burden, assessing multiple efficacy and patient-reported outcomes following 3 months of treatment, in accordance with International Headache Society (IHS) guidelines.

Conditions

• Migraine
• Chronic Migraine Headache

Interventions

Type	Name	Description
DEVICE	Nerivio REN device	Remote electrical neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-dministered and vcontrolled by a smartphone application

Timeline

• Start date: 2026-02-20
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study