Efficacy and safety of tonic motor activation for the treatment of restless legs syndrome: A meta-analysis of randomized controlled trials.

INTRODUCTION

Restless Legs Syndrome (RLS) is a common neurological condition characterized by an uncontrollable urge to move the legs, particularly at night, often leading to chronic sleep disturbances. The tonic motor activation (TOMAC) system, a novel noninvasive and nonpharmacological therapy, has been proposed as a potential treatment for moderate to severe RLS, though its safety and efficacy remain unclear.

METHODS

A thorough search was conducted across PubMed, Web of Science, Scopus, and the Cochrane Library up to December 2024 to identify studies comparing TOMAC with sham interventions. Key outcomes included the mean change in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score, the Patient Global Impressions-Improvement (PGI-I) Responder Rate, and changes in sleep indices (MOS-I and MOS-II). Secondary outcomes examined adverse events (AEs) and their severity, as well as discontinuations due to AEs.

RESULTS

Four studies comprising 320 patients were included. TOMAC significantly reduced IRLS scores compared to the sham group (MD -3.66, 95 % CI [-5.07, -2.25], P < 0.00001). It also improved PGI-I responder rates (RR 3.16, 95 % CI [1.35, 7.37], P = 0.008) and reduced MOS-I (MD -9.28, 95 % CI [-13.43, -5.13], P < 0.00001) and MOS-II scores (MD -10.06, 95 % CI [-14.17, -5.94], P < 0.00001). Adverse events were more frequent in the TOMAC group but were generally mild and resolved without medical intervention.

CONCLUSION

TOMAC offers a promising, effective, and tolerable nonpharmacological option for managing RLS, significantly improving symptom severity and sleep quality.