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Nerivio Efficacy by Time of Treatment Onset

NCT06976723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55261

Last updated 2025-07-31

No results posted yet for this study

Summary

This is a Post-marketing study investigating the impact of treatment time onset with Nerivio on the efficacy of Remote Electrical Neuromodulation (REN) for the acute treatment of migraine.

Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments, based on the treatment start time from the beginning of the migraine attack.

Conditions

Interventions

DEVICE

Nerivio

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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2025-06-10
Completion
2025-06-15
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 NCT06976723 on ClinicalTrials.gov