An interventional study of Nerivio REN device in Migraine, sponsored by Theranica. Completed at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Theranica · Not applicable, Interventional, and Prevention
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. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study will evaluate the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in migraine patients.
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 the potential benefits for almost 40% of this population. 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. 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 migraine, assessing multiple efficacy and patient-reported outcomes following 3 months of treatment, in accordance with International Headache Society (IHS) guidelines.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 332 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Nerivio users who were prescribed with the REN wearable for their routine migraine care and treated in a prevention-like manner over 3 consecutive months
Device: Nerivio REN device
Remote electrical neuromodulation (REN) device for the acute treatment of migraine. 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-administered and controlled by a smartphone application
Change in average number of monthly migraine days (MMD)
Change in average number of monthly migraine days (MMD) from baseline to 3-months follow-up questionnaire.
Time frame: 3 months
Patients clinical improvement
Proportion of patients reporting improvement on PGIC scale at 3-months follow-up questionnaire.
Time frame: 3 months
Change in migraine attack duration
Change in average migraine attack duration from baseline to 3-months follow-up questionnaire.
Time frame: 3 months
Device Safety
Rate of serious adverse events, adverse events and device-related adverse events
Time frame: 3 months
Change in acute migraine drug intake
Change in the percentage of treatments with acute migraine drug use.
Time frame: 3 months
Reduction of >30% in all outcome measures (MMD, migraine attack duration, acute intake medication)
A clinically meaningful response, defined as the percentage of patients achieving a ≥30% reduction in MMDs, migraine attack duration, and acute drug use.
Time frame: 3 months
Change in migraine attack severity
Change in typical migraine attacks severity from baseline to 3-months follow-up questionnaire.
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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