NCT06138756Completed
Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 293 (actual)
- First submitted
- 11 Nov 2023
- Start date
- Oct 2023
- Primary completion date
- May 2024
- Lead sponsor
- Theranica
- Diseases
- Migraine
- NCT number
- NCT06138756
What you commit to
- Study type: Observational
- Participants enrolled: 293
- From Oct 2023 to the primary completion date, May 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- Subject age is between 6 to 12 at the date of the REN treatment
- Subject used the Nerivio device at least once
Age in the registry: 6 years to 12 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Theranica Bio-Electronics Ltd Coordinator of this site? Confirm its status | Netanya | Israel | Unknown status |
| Theranica USA Inc Coordinator of this site? Confirm its status | Bridgewater | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.