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

ClinicalTrials.gov ID: NCT06138756

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Official title

A Prospective, Single Arm, Open Label Post Market Study Assessing the Safety and Efficacy of Nerivio for the Treatment of Migraine in Children Under the Age of 12

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06138756
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Theranica; Industry
Enrollment: 293 participants

Conditions and interventions

Conditions

Migraine

Interventions

Nerivio Device

Device

Eligibility (public fields only)

Age range: 6 Years to 12 Years
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 1, 2023 (Actual)
Primary completion: May 18, 2024 (Actual)
Completion: Jun 1, 2024 (Actual)
Last update posted: Sep 15, 2025

2023 – 2024

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Theranica USA Inc	Bridgewater	New Jersey	08807	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06138756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 15, 2025 · Synced Nov 12, 2026