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NCT Number: NCT06076499

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mark J Buchfuhrer, MD Office, Downey, California, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 is unable or unwilling to comply with study requirements.

Treatment and study plan

NTX100

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: 1 year

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

Secondary outcomes

  1. CGI-I score at 1-year relative to baseline

    Time frame: 1 year

    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).

  2. PGI-I Score at 1-Year Relative to Baseline

    Time frame: 1 year

    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).

  3. Change from baseline in MOS-II total score at 1-year.

    Time frame: 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.

  4. Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year

    Time frame: 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.

Other outcomes

  1. CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year.

    Time frame: 1-year

    This metric gauges the proportion of patients showing significant improvement after one year of treatment, defined as a "Very Much Improved" or "Much Improved" CGI-I response.

  2. CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".

    Time frame: 1-year

    This measure indicates the percentage of patients experiencing positive change due to treatment, encompassing "Very Much Improved," "Much Improved," and "Minimally Improved" CGI-I responses.

Sponsors and collaborators

Lead sponsor

Noctrix Health, Inc.

Industry

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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