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