title: Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.
abstract: BACKGROUND
  Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored.
  
  
  OBJECTIVE
  The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function.
  
  
  METHODS
  A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted.
  
  
  METHODS
  The study was conducted in a university pediatric research laboratory.
  
  
  METHODS
  Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated.
  
  
  METHODS
  Adverse events/safety assessment and hand function were measured.
  
  
  METHODS
  Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events.
  
  
  RESULTS
  No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis.
  
  
  CONCLUSIONS
  A limitation of the study was the small sample size, with data available for 11 participants.
  
  
  CONCLUSIONS
  Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function.
authors.affiliation: B.T. Gillick, PT, MSPT, PhD, University of Minnesota, 420 Delaware St SE, MMC 388, Minneapolis, MN 55455 (USA). gillick@umn.edu.
authors.forename: Bernadette T
authors.initials: BT
authors.lastname: Gillick
authors.affiliation: T. Feyma, MD, Pediatric Neurology, Gillette Children's Specialty Healthcare, St Paul, Minnesota.
authors.forename: Tim
authors.initials: T
authors.lastname: Feyma
authors.affiliation: J. Menk, MS, Clinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Menk
authors.affiliation: M. Usset, DPT, Program in Physical Therapy, University of Minnesota.
authors.forename: Michelle
authors.initials: M
authors.lastname: Usset
authors.affiliation: A. Vaith, DPT, Program in Physical Therapy, University of Minnesota.
authors.forename: Amy
authors.initials: A
authors.lastname: Vaith
authors.affiliation: T.J. Wood, DPT, Program in Physical Therapy, University of Minnesota.
authors.forename: Teddi Jean
authors.initials: TJ
authors.lastname: Wood
authors.affiliation: R. Worthington, DPT, Program in Physical Therapy, University of Minnesota.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Worthington
authors.affiliation: L.E. Krach, MD, Physical Medicine and Rehabilitation, University of Minnesota.
authors.forename: Linda E
authors.initials: LE
authors.lastname: Krach
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D004311:Double-Blind Method; D019054:Evoked Potentials, Motor; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D018737:Hand Strength; D006801:Humans; D008297:Male; D010291:Paresis / Q000151:congenital* / Q000503:physiopathology / Q000628:therapy*; D065908:Transcranial Direct Current Stimulation; D016896:Treatment Outcome