Nerivio Efficacy Under High-Frequency Use

January 9, 2026 updated by: Theranica

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs and up to 40 mA output current, which the patient can adjust. The REN device is operated by a designated app that is downloaded to the user's phone prior to first use of the Nerivio device. As part of the sign-up process for the Nerivio app, all patients accept the terms of use, which specify that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback.

The app includes a secure, personal migraine diary, which enables patients to record and track their migraines and other headaches. At the beginning of each treatment, and again at 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (None, Mild limitation, Moderate limitation, Severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.

Post-marketing surveillance is designed to assess the safety, utilization, and efficacy in larger and more diverse populations and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.

According to the indication, acute treatment with REN should start as early as possible once a migraine attack begins, or every other day for preventive treatment. Given that the instruction is to use "as needed", empowering patients to find the best treatment regime that works for them, real-world treatment patterns may deviate from the approved indication. As patients are not limited in the number of treatments they can conduct per day, nor by the number of treatment days per month, some patients who experience frequent and severe headaches and associated-symptoms, have adopted more frequent treatment regimens, including multiple treatments within a single day, daily use, or a combination of both patterns. The safety profile of REN under such frequent use conditions has not been systematically evaluated.

The objective of this study is to assess the safety and tolerability of the REN wearable device when used at frequencies exceeding the labeled indication, defined as either multiple treatments per day or daily use, using real-world data from patients who were prescribed the device as part of their routine migraine care.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Theranica USA Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nerivio user
  • Treated at least 4 times in a singe day, Or: treated at leastonce in 25 out of 28 consecutive days

ExclusiveCriteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nerivio users who treated with nerivio in patterns acceding the indication for use

Nerivio users who treatedfrequantly with Nerivio under the following regiemes:

  1. - Multiple treatments per day: defined as administrating 4 or more full treatments on a single day.
  2. - Administrating at least one full treatment on 25 or more days within a 28-day period. For each patient, all possible 28-day windows containing at least 25 treatment days were identified.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of Nerivio treatment
Time Frame: up to 5 years
Rate of serious adverse events, adverse events and device-related adverse events
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranica

Investigators

  • Principal Investigator: Alit Stark-Inbar, PhD, Theranica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RWE-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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