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ACTIVE NOT RECRUITING
NCT06076499

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Sponsor: Noctrix Health, Inc.

View on ClinicalTrials.gov

Summary

Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.

Official title: A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix NTX100 TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

325

Start Date

2023-11-15

Completion Date

2026-12

Last Updated

2025-07-24

Healthy Volunteers

Not specified

Interventions

DEVICE

NTX100

NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.

Locations (6)

Mark J Buchfuhrer, MD Office

Downey, California, United States

Sleep Medicine Specialists of California

San Ramon, California, United States

Neurocare, Inc.

Newton, Massachusetts, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Ohio Sleep Medicine and Institute

Dublin, Ohio, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States