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.
Aggarwal et al. (Fri,) studied this question.