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A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS | Clinical Trials | Clareo Health

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

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

NCT06076499•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.

Detailed Description

This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
•2. The subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
•3. Diagnosis of restless legs syndrome.

Exclusion Criteria

•1\. The subject is unable or unwilling to comply with study requirements.

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

Key Dates

Start Date

November 15, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

July 24, 2025

Enrollment

325

ESTIMATED participants

Conditions

Restless Legs Syndrome

Interventions

NTX100

DEVICE

Functional Connectivity of the Interoceptive Network in RLS

NCT07001891

Restless Legs Syndrome

View study

RECRUITINGNA

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

NCT05908214

StrokeCramp+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Functional Connectivity of the Interoceptive Network in RLS

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Quality Improvement and Practice Based Research in Neurology Using the EMR

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Impact of Iron Supplementation Treatment on Brain Iron Concentrations

Advancing Understanding of Transportation Options