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Nerivio Efficacy Under High-Frequency Use

NCT07336056 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-01-13

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Alit Stark-Inbar, PhD · Theranica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2026-01-20
Completion
2026-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336056 on ClinicalTrials.gov