N/A N=293

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

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT06138756 ↗

Enrolled (actual)

293

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Rate of Device Related Adverse Events — 0 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Nerivio (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Theranica
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Device Related Adverse Events	—	—
SECONDARY Consistent Headache Relief at 2 Hours Post-treatment	13	—
SECONDARY Consistent Freedom From Headache at 2 Hours Post-treatment	9	—
SECONDARY Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment	7; 2; 4; 7	—
SECONDARY Consistent Functional Disability Relief at 2 Hours Post-treatment	15	—
SECONDARY Consistent Functional Disability Disappearance at 2 Hours Post-treatment	7	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06138756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.