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Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence

NCT05769322 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2024-11-22

No results posted yet for this study

Summary

This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.

Conditions

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
2023-04-01
Primary Completion
2023-04-15
Completion
2023-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05769322 on ClinicalTrials.gov