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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Device: NTX100

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.

• Study Type: Observational
• Enrollment (Estimated): 325

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90241
      • Mark J Buchfuhrer, MD Office
    • San Ramon, California, United States, 94583
      • Sleep Medicine Specialists of California
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Neurocare, Inc.
  • Missouri
    • St Louis, Missouri, United States, 63123
      • Clayton Sleep Institute
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine and Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population will consist of adults who meet the inclusion and exclusion criteria.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 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.	1-year
CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".	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.	1-year

Collaborators and Investigators

• Sponsor: Noctrix Health, Inc.
• Investigators: Study Director: Jessica Preciado, PhD, Noctrix Health, Inc.

Publications and helpful links

General Publications

• Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.
• Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536.
• Bogan RK, Roy A, Kram J, Ojile J, Rosenberg R, Hudson JD, Scheuller HS, Winkelman JW, Charlesworth JD. Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial. Sleep. 2023 Oct 11;46(10):zsad190. doi: 10.1093/sleep/zsad190.
• Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188.

Helpful Links

• Noninvasive neuromodulation reduces symptoms of restless legs syndrome
• Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: RLS
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Restless Legs Syndrome
• Other Study ID Numbers: CT-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No