NCT07336056

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

12 days

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Migraine

Keywords

treatment of migraineRemote Electrical NeuromodulationNerivio

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of Nerivio treatment

    Rate of serious adverse events, adverse events and device-related adverse events

    up to 5 years

Study Arms (1)

Nerivio users who treated with nerivio in patterns acceding the indication for use

ACTIVE COMPARATOR

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)

Interventions

Nerivio (REN device)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

Nerivio users who treated with nerivio in patterns acceding the indication for use

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nerivio user
  • Treated at least 4 times in a singe day, Or: treated at leastonce in 25 out of 28 consecutive days
  • ExclusiveCriteria:
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

  • Rastogi RG, Santiago JA, Chang A, Mama E, Stark-Inbar A, Ironi A, Towne AR, Werner K. A Real-World Evidence Study on US Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment. Pain Ther. 2026 Mar 26. doi: 10.1007/s40122-026-00828-9. Online ahead of print.

    PMID: 41886224DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alit Stark-Inbar, PhD

    Theranica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: REN treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 13, 2026

Study Start

January 8, 2026

Primary Completion

January 20, 2026

Study Completion

January 30, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)