0713 Long-term response to tonic motor activation (TOMAC) therapy for refractory restless legs syndrome

Abstract Introduction There is a large population of patients who have become refractory to first-line treatments for Restless Legs Syndrome, partially due to augmentation to dopamine agonist medications. For patients with refractory RLS, tonic motor activation (TOMAC) is a noninvasive medical device therapy with promising short-term safety and efficacy. Here, we evaluated the response to TOMAC over a longer duration of >24 weeks. Methods In the RESTFUL study, 133 patients with primary moderate-severe refractory RLS were 1:1 randomized to TOMAC or sham control for weeks 1 to 4 followed by open-label TOMAC for weeks 5 to 8. The final 50 participants to complete the RESTFUL study were invited to continue TOMAC treatment for an additional 24 weeks (weeks 9 to 32) in an extension study. Participants were instructed to self-administer one 30-minute TOMAC session bilaterally over the peroneal nerve whenever RLS symptoms presented. Efficacy was assessed by comparing responses from baseline (RESTFUL study entry, week 0) to week 32 on Clinician Global Impressions-Improvement (CGI-I) responder rate, Patient Global Impressions-Improvement (PGI-I) responder rate, and International RLS Study Group Rating Scale (IRLS) total score. Additional analyses compared responses from week 8 (RESTFUL study completion) to week 32. Results Of the 50 eligible participants, 44 consented to the extension study and 42 completed. CGI-I responder rate relative to baseline increased from 64% at week 8 to 76% at week 32. PGI-I responder rate relative to baseline increased from 68% at week 8 to 77% at week 32. IRLS total score reduced from 24.5 at baseline to 17.1 at week 8 to 12.9 at week 32, a reduction of 11.6 points from baseline to week 32. There were no moderate or severe device-related AEs. Conclusion TOMAC resulted in substantial and clinically significant reduction in RLS symptom severity that was maintained through >24 weeks of treatment. Furthermore, there was a trend towards increased efficacy with continued use of TOMAC. These data suggest that TOMAC could represent a potential long-term treatment for the chronic condition of refractory RLS. Support (if any) Funding was provided by Noctrix Health, Inc.