Transcranial direct current stimulation on primary sensorimotor area has no effect in patients with drug-naïve restless legs syndrome: a proof-of-concept clinical trial

Yong Seo Koo, Sung Min Kim, Chany Lee, Byeong Uk Lee, Ye Ji Moon, Yong Won Cho, Chang-Hwan Im, Jeong Woo Choi, Kyung Hwan Kim, Ki-Young Jung
2015 Sleep Medicine  
A B S T R A C T Objective: To evaluate the efficacy of transcranial direct current stimulation (tDCS) in people with drugnaïve restless legs syndrome (RLS). Methods: A two-week, double-blind, randomized, sham-controlled trial was performed. Thirty-three females with RLS were recruited. Participants received five sessions of tDCS using cathodal, anodal or sham stimulation. They were assessed at baseline (T0), three days (T1) and 13 days (T2) after the end of tDCS. Primary outcomes included the
more » ... ternational RLS Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I). Secondary outcomes included the Patient Global Impression scale, the Pittsburgh Sleep Quality Index, the Medical Outcome Study sleep subscales, and the Beck Depression Inventory. Objective neurophysiological changes were assessed using event-related desynchronization/synchronization (ERD/ERS) of electroencephalography. Results: The changes in the IRLS scores, as well as the responder rate in the CGI-I scale, did not differ significantly among the groups. There was also no significant difference in any of the secondary outcome measures and ERD/ERS among the groups. Conclusions: Transcranial direct current stimulation with electrodes on the sensorimotor areas showed no significant effect in people with drug-naïve RLS.
doi:10.1016/j.sleep.2014.07.032 pmid:25576136 fatcat:34zvudh5bfcejaw2wmyvelvxnu