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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX100 | Device | NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Change from baseline (study entry) in IRLS total score at 1-year. | 1 year |
| 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 |
| 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". |
Inclusion Criteria:
Exclusion Criteria:
1. The subject is unable or unwilling to comply with study requirements.
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The study population will consist of adults who meet the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Preciado, PhD | Noctrix Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mark J Buchfuhrer, MD Office | Downey | California | 90241 | United States | ||
| Sleep Medicine Specialists of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33949942 | Background | 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. | |
| 36856064 | Background | 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. |
| Label | URL |
|---|---|
| Noninvasive neuromodulation reduces symptoms of restless legs syndrome | View source |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| 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 |
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 |
| San Ramon |
| California |
| 94583 |
| United States |
| Neurocare, Inc. | Newton | Massachusetts | 02459 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | United States |
| Ohio Sleep Medicine and Institute | Dublin | Ohio | 43017 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | United States |
| 37458698 | Background | 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. |
| 37439365 | Background | 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. |
| 42231562 | Derived | Singh H, Buchfuhrer MJ, Ojile J, Roy A, Thomas RJ, Bogan RK, Aggarwal A, Preciado J, Swartz KJ, Charlesworth JD. Real-world effectiveness and safety of tonic motor activation therapy for refractory restless legs syndrome: 90-day outcomes from the THRIVE prospective observational study. Sleep. 2026 Jun 3:zsag140. doi: 10.1093/sleep/zsag140. Online ahead of print. |
| Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms | View source |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |