title: 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.
abstract: OBJECTIVE
  To evaluate the efficacy of transcranial direct current stimulation (tDCS) in people with drug-naïve 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 International 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.
authors.affiliation: Department of Neurology, Korea University Medical Center Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
authors.forename: Yong Seo
authors.initials: YS
authors.lastname: Koo
authors.affiliation: Department of Neurology, Korea University Medical Center Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
authors.forename: Sung Min
authors.initials: SM
authors.lastname: Kim
authors.affiliation: Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Chany
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Byeong Uk
authors.initials: BU
authors.lastname: Lee
authors.affiliation: Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Ye Ji
authors.initials: YJ
authors.lastname: Moon
authors.affiliation: Department of Neurology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea.
authors.forename: Yong Won
authors.initials: YW
authors.lastname: Cho
authors.affiliation: Department of Biomedical Engineering, Hanyang University, Seoul, South Korea.
authors.forename: Chang-Hwan
authors.initials: CH
authors.lastname: Im
authors.affiliation: Department of Biomedical Engineering, College of Health Science, Yonsei University, Wonju, Gangwon-do, South Korea.
authors.forename: Jeong Woo
authors.initials: JW
authors.lastname: Choi
authors.affiliation: Department of Biomedical Engineering, College of Health Science, Yonsei University, Wonju, Gangwon-do, South Korea.
authors.forename: Kyung Hwan
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: jungky10@gmail.com.
authors.forename: Ki-Young
authors.initials: KY
authors.lastname: Jung
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004569:Electroencephalography; D005071:Evoked Potentials / Q000502:physiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D012148:Restless Legs Syndrome / Q000503:physiopathology / Q000628:therapy*; D066191:Sensorimotor Cortex / Q000503:physiopathology*; D065908:Transcranial Direct Current Stimulation / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
keywords: Cortical excitability; Event-related synchronization; Non-pharmacological treatment; Restless legs syndrome; Transcranial direct current stimulation