title: Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol.
abstract: BACKGROUND
  Perinatal stroke occurs in more than 1 in 2,500 live births and resultant congenital hemiparesis necessitates investigation into interventions which may improve long-term function and decreased burden of care beyond current therapies ( http://www.cdc.gov/ncbddd/cp/data.html ). Constraint-Induced Movement Therapy (CIMT) is recognized as an effective hemiparesis rehabilitation intervention. Transcranial direct current stimulation as an adjunct treatment to CIMT may potentiate neuroplastic responses and improve motor function. The methodology of a clinical trial in children designed as a placebo-controlled, serial -session, non-invasive brain stimulation trial incorporating CIMT is described here. The primary hypotheses are 1) that no serious adverse events will occur in children receiving non-invasive brain stimulation and 2) that children in the stimulation intervention group will show significant improvements in hand motor function compared to children in the placebo stimulation control group.
  
  
  METHODS
  A randomized, controlled, double-blinded clinical trial. Twenty children and/or young adults (ages 8-21) with congenital hemiparesis, will be enrolled. The intervention group will receive ten 2-hour sessions of transcranial direct current stimulation combined with constraint-induced movement therapy and the control group will receive sham stimulation with CIMT. The primary outcome measure is safety assessment of transcranial direct current stimulation by physician evaluation, vital sign monitoring and symptom reports. Additionally, hand function will be evaluated using the Assisting Hand Assessment, grip strength and assessment of goals using the Canadian Occupational Performance Measure. Neuroimaging will confirm diagnoses, corticospinal tract integrity and cortical activation. Motor cortical excitability will also be examined using transcranial magnetic stimulation techniques.
  
  
  CONCLUSIONS
  Combining non-invasive brain stimulation and CIMT interventions has the potential to improve motor function in children with congenital hemiparesis beyond each intervention independently. Such a combined intervention has the potential to benefit an individual throughout their lifetime.
  
  
  BACKGROUND
  Clinicaltrials.gov, NCT02250092 Registered 18 September 2014.
authors.affiliation: University of Minnesota, 420 Delaware Street SE, MMC 388, Minneapolis, MN, 55455, USA. gillick@umn.edu.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Gillick
authors.affiliation: Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, MN, 55455, USA. menk0023@umn.edu.
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Menk
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, MN, 55455, USA. muell093@umn.edu.
authors.forename: Bryon
authors.initials: B
authors.lastname: Mueller
authors.affiliation: Department of Neurology, University of Minnesota, Minneapolis, MN, USA. gmeekins@umn.edu.
authors.forename: Gregg
authors.initials: G
authors.lastname: Meekins
authors.affiliation: Courage Kenny Rehabilitation Institute, part of Allina Health, 800 East 28th Street, Minneapolis, MN, 55407, USA. linda.krach@allina.com.
authors.forename: Linda E
authors.initials: LE
authors.lastname: Krach
authors.affiliation: Department of Neurology, Gillette Children's Specialty Healthcare, 200 University Ave E, Saint Paul, MN, 55101, USA. TFeyma@gillettechildrens.com.
authors.forename: Timothy
authors.initials: T
authors.lastname: Feyma
authors.affiliation: Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA. rudser@umn.edu.
authors.forename: Kyle
authors.initials: K
authors.lastname: Rudser
mesh_terms: D000293:Adolescent; D002648:Child; D004311:Double-Blind Method; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006225:Hand / Q000503:physiopathology*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D009043:Motor Activity / Q000502:physiology*; D010291:Paresis / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D065908:Transcranial Direct Current Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult