0794 Long-Term Real-World Outcomes of Tonic Motor Activation (TOMAC) for Refractory Restless Legs Syndrome (RLS): Interim 1-Year Data from the THRIVE Study

Abstract Introduction Tonic motor activation (TOMAC) is a non-invasive therapy which delivers high-frequency electrical stimulation to the peroneal nerve to reduce symptoms of restless legs syndrome (RLS). Here, we report for the first time on 1-year outcomes from patients prescribed TOMAC therapy. Methods All patients who were prescribed Nidra® TOMAC (Noctrix Health Inc.) were invited to participate in the THRIVE multi-center prospective observational post-market study. In accordance with the prespecified statistical analysis plan, we conducted intent-to-treat analysis of all patients who met the FDA indication for TOMAC (adults with primary moderate-severe refractory RLS who were not contraindicated). Patients in this indicated intent-to-treat (IITT) population who were enrolled >1 year before the analysis date (October 15th, 2025) were analyzed. Missing data were imputed. Outcome metrics were collected at baseline prior to starting TOMAC and during follow-up visits every 90 days. The prespecified primary outcome was change in IRLS score at 1 year compared to baseline. Secondary outcomes were PGI-I score, CGI-I score, change in MOS-II score, and change in days per week with RLS symptoms at 1 year relative to baseline. Results The interim IITT population included 78 patients. IRLS score reduced from 26.1 at baseline to 16.7 at 1 year of TOMAC, a mean change of -9.4 (95% CI: -11.0, -7.8). PGI-I score was 2.6 (95% CI: 2.3, 2.9; responder rate: 54%) and CGI-I score was 2.3 (95% CI: 2.0, 2.6; responder rate: 65%). MOS-II reduced from 53.0 to 40.5, a mean change of -12.5 (95% CI: -17.0, -8.0). Days per week with RLS symptoms reduced from 6.2 to 4.4, a mean change of -1.8 days (95% CI: -1.3, -2.3). Of the 43 patients on dopamine agonist medication at baseline, 15 reduced dosage (average dosage reduction: 60%, 95% CI: 45%, 85%) and 4 increased dosage. The most common adverse effects were administration site reactions; none were serious or severe. Conclusion These interim data suggest that TOMAC therapy is safe and effective through 1 year of use. Response in real-world clinical practice is similar to previously reported outcomes from randomized clinical trials. Support (if any) The THRIVE study was sponsored by Noctrix Health, Inc.