Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

NCT06138756 | Completed Results FDA Device

• 1 other identifier: RWE009
• Study Type: observational
• Target: 293
• Locations: 2 countries
• Sites: 2

Brief Summary

Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.

Conditions

Migraine

Keywords

REN; Nerivio; Children

Outcome Measures

Primary Outcomes (1)

• Rate of Device Related Adverse Events

  Incidence of device-related adverse events reported by subjects throughout the study period

  Up to 6 months

Secondary Outcomes (5)

• Consistent Headache Relief at 2 Hours Post-treatment

  up to 6 months

• Consistent Freedom From Headache at 2 Hours Post-treatment

  up to 6 months

• Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment

  up to 6 months

• Consistent Functional Disability Relief at 2 Hours Post-treatment

  up to 6 months

• Consistent Functional Disability Disappearance at 2 Hours Post-treatment

  up to 6 months

Study Arms (1)

Pre-adolescents with migraine

Patients at the age of 6-11 (included) with migraine who were prescribed the Nerivio device by their healthcare provider and used the Nerivio device at least once

Device: Nerivio

Interventions

Nerivio DEVICE

Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine

Pre-adolescents with migraine

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pre-adolescents (age 6-11) who suffer from migraine and use the Nerivio device for acute treatment of migraine.

You may qualify if:

• Subject age is between 6 to 12 at the date of the REN treatment
• Subject used the Nerivio device at least once

You may not qualify if:

• None

Sponsors & Collaborators

• Theranica: lead

Study Sites (2)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

Theranica Bio-Electronics Ltd

Netanya, 4250438, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

A post-marketing cohort study without a control group; not all participants provided data for efficacy calculations; age among the cohort of children is not uniformly distributed.

Results Point of Contact

• Title: Dr Dagan Harris
• Organization: Theranica

daganh@theranica.com

+972-73-3703649

Study Officials

• Alit Stark-Inbar, PhD

  Theranica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: October 1, 2023
• Primary Completion: May 18, 2024
• Study Completion: June 1, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)