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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Device: NTX100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Diagnosis of restless legs syndrome. Exclusion Criteria: The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) The subject has a metal implant at the site of the study device electrode application (not including knee replacements). The subject has been diagnosed with one of the following conditions: • Epilepsy or other seizure disorder The subject has a moderate or severe cognitive disorder or mental illness. The subject has a known allergy to device materials (or a previous severe reaction to medical adhesives or bandages). Subject has any of the following at or near the location of the device application: Acute injury Cellulitis Open sores The subject is unable or unwilling to comply with study requirements. The subject is pregnant or trying to become pregnant

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NTX100|NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Change from baseline (study entry) in IRLS total score at 1-year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I score at 1-year relative to baseline | The 1-year Clinical Global Impression-Improvement (CGI-I) score assesses a patient's overall condition relative to their baseline, indicating treatment effectiveness and change in condition over a year. Scores range from 1 (very much improved) to 7 (very much worse). | 1 year | 
| PGI-I Score at 1-Year Relative to Baseline | The 1-year Patient Global Impression-Improvement (PGI-I) score assesses the patient's perception of their condition's improvement from baseline, with scores ranging from 1 (very much improved) to 7 (very much worse). | 1 year | 
| Change from baseline in MOS-II total score at 1-year. | The Medical Outcomes Study 36-Item Short Form Health Survey (MOS-II) measures various aspects of a patient's health-related quality of life. This endpoint assesses the change in the total MOS-II score at the 1-year mark compared to the baseline, and how the treatment impacts overall well-being over the course of a year. | 1-year | 
| Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year | This endpoint focuses on Restless Legs Syndrome (RLS) and assesses the change in symptom frequency over a year. It quantifies the reduction in the number of days per week that a patient experiences RLS symptoms, indicating the treatment's effectiveness in managing this condition over time. | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RLS