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Real-world Data Analysis of REN Treatment in Adolescence With Migraine

NCT05443659 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1629

Last updated 2025-11-04

Study results available
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Summary

This is a Post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, Israel) in adolescents with migraine. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.

Conditions

  • Migraine in Adolescence

Interventions

DEVICE

Nerivio

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.

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Alit Stark Inbar, PhD · Theranica Bio-Electronics ltd

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-05-31
Completion
2022-08-24
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05443659 on ClinicalTrials.gov