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

N/AActive Not RecruitingNCT06076499

Noctrix Health, Inc.325 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

325

Conditions

Restless Legs Syndrome

Interventions

NTX100DEVICE

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 (7)

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

Outcomes

Primary Outcomes

Primary Effectiveness Endpoint

Change from baseline (study entry) in IRLS total score at 1-year.

Time frame: 1 year

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 1-year

Data from ClinicalTrials.gov

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