An observational study in Restless Legs Syndrome, sponsored by Noctrix Health, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Noctrix Health, Inc. · Observational
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.
248 studies on the registry are indexed under Restless Legs Syndrome; 39 are open to participants now.
This study's planned enrollment of 325 is close to the median of 310 across 44 observational studies indexed under Restless Legs Syndrome.
Browse Restless Legs Syndrome studies →Noctrix Health, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults who meet the inclusion and exclusion criteria.
Exclusion Criteria:
1. The subject is unable or unwilling to comply with study requirements.
NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.
Primary Effectiveness Endpoint
Change from baseline (study entry) in IRLS total score at 1-year.
Time frame: 1 year
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
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.
Time frame: 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.
Time frame: 1-year
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Noctrix Health, Inc.