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ACTIVE NOT RECRUITING
NCT07336056
PHASE4

Nerivio Efficacy Under High-Frequency Use

Sponsor: Theranica

View on ClinicalTrials.gov

Summary

This is a Post-marketing study investigating the impact of frequant usage with Nerivio on the safety profile of Remote Electrical Neuromodulation (REN) for the treatment of migraine. This study assessed the safety and tolerability of REN when used at frequencies exceeding the labeled indication.

Official title: Safety Profile of High-Frequency Use of a Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-01-08

Completion Date

2026-01-30

Last Updated

2026-01-13

Healthy Volunteers

No

Conditions

Interventions

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-administered and controlled by a smartphone application

Locations (1)

Theranica USA Inc

Bridgewater, New Jersey, United States