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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Theranica
Study ID
NCT06138756
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Nerivio — DEVICE
    Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Nov 2023
Primary completion
May 18, 2024
Completion
Jun 1, 2024

Study Design

Enrollment
293 participants (actual)

Arms

  • Arm: Pre-adolescents with migraine
    Patients at the age of 6-11 (included) with migraine who were prescribed the Nerivio device by their healthcare provider and used the Nerivio device at least once

Primary Outcome Measure

Rate of Device Related Adverse Events [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Theranica USA IncBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By condition
Migraine
By specialty
Neurology
By research site
Theranica USA Inc· Bridgewater, NJ

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