Real-world effectiveness and safety of tonic motor activation therapy for refractory restless legs syndrome: 90-day outcomes from the THRIVE prospective observational study

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2026
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Abstract
STUDY OBJECTIVES: The purpose of the THRIVE study is to evaluate the outcomes of patients receiving tonic motor activation (TOMAC) for treatment of refractory restless legs syndrome (RLS) in real-world clinical practice. This article examines outcomes after 90 days of TOMAC treatment. METHODS: THRIVE is a multicenter, prospective, observational study that enrolled 325 patients prescribed TOMAC (Nidra®) for the treatment of RLS. The indicated intent-to-treat (IITT) analysis population included adults with refractory moderate-severe RLS. The primary endpoint was change in International RLS Study Group (IRLS) score. Secondary endpoints included Clinician Global Impressions-Improvement (CGI-I) score and change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score. Adjunctive RLS medications were assessed at study entry and Day 90. RESULTS: A total of 232 patients met criteria for IITT analysis. Change in IRLS score at Day 90 was -8.4 (95% CI: -7.4 to -9.4). CGI-I responder rate was 64% and mean score was 2.4 (95% CI: 2.2 to 2.6). Change in MOS-II score was -12.8 (95% CI -10.3, -15.3). Reductions to adjunctive RLS medication dosage were more common than increases (19% decreased versus 11% increased; p = 0.01) and were well-tolerated (mean IRLS change: -8.1; 95% CI -6.3, -9.9). There were no statistically significant predictors of effectiveness. There were no severe or serious device-related adverse events. CONCLUSIONS: In real-world clinical practice, TOMAC is safe and effective at reducing RLS symptoms and improving sleep in adults with moderate-to-severe refractory RLS. CLINICAL TRIAL: A Post-Market Study for Long-Term Effectiveness and Safety of the Noctrix TOMAC System for RLS (THRIVE); https://clinicaltrials.gov/study/NCT06076499; Registered at ClinicalTrials.gov with the identifier number NCT06076499.
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Authors Haramandeep Singh, Mark J. Buchfuhrer, Joseph Ojile, Asim Roy, Robert J. Thomas, R K Bogan, Avinash Aggarwal, Jessica Preciado, K. Swartz, J. Charlesworth
Journal Sleep & breathing = Schlaf & Atmung
Year 2026
DOI
10.1093/sleep/zsag140
URL
https://doi.org/10.1093/sleep/zsag140
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