title: Safety of primed repetitive transcranial magnetic stimulation and modified constraint-induced movement therapy in a randomized controlled trial in pediatric hemiparesis.
abstract: OBJECTIVE
  To investigate the safety of combining a 6-Hz primed low-frequency repetitive transcranial magnetic stimulation (rTMS) intervention in the contralesional hemisphere with a modified constraint-induced movement therapy (mCIMT) program in children with congenital hemiparesis.
  
  
  METHODS
  Phase 1 randomized, double-blinded, placebo-controlled pretest/posttest trial.
  
  
  METHODS
  University academic facility and pediatric specialty hospital.
  
  
  METHODS
  Subjects (N = 19; age range, 8-17 y) with congenital hemiparesis caused by ischemic stroke or periventricular leukomalacia. No subject withdrew because of adverse events. All subjects included completed the study.
  
  
  METHODS
  Subjects were randomized to 1 of 2 groups: either real rTMS plus mCIMT (n = 10) or sham rTMS plus mCIMT (n = 9).
  
  
  METHODS
  Adverse events, physician assessment, ipsilateral hand function, stereognosis, cognitive function, subject report of symptoms assessment, and subject questionnaire.
  
  
  RESULTS
  No major adverse events occurred. Minor adverse events were found in both groups. The most common events were headaches (real: 50%, sham: 89%; P = .14) and cast irritation (real: 30%, sham: 44%; P = .65). No differences between groups in secondary cognitive and unaffected hand motor measures were found.
  
  
  CONCLUSIONS
  Primed rTMS can be used safely with mCIMT in congenital hemiparesis. We provide new information on the use of rTMS in combination with mCIMT in children. These findings could be useful in research and future clinical applications in advancing function in congenital hemiparesis.
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Minnesota Medical School, Minneapolis, MN. Electronic address: gillick@umn.edu.
authors.forename: Bernadette T
authors.initials: BT
authors.lastname: Gillick
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Minnesota Medical School, Minneapolis, MN; Gillette Children's Specialty Healthcare, St Paul, MN.
authors.forename: Linda E
authors.initials: LE
authors.lastname: Krach
authors.affiliation: Gillette Children's Specialty Healthcare, St Paul, MN.
authors.forename: Tim
authors.initials: T
authors.lastname: Feyma
authors.affiliation: Gillette Children's Specialty Healthcare, St Paul, MN.
authors.forename: Tonya L
authors.initials: TL
authors.lastname: Rich
authors.affiliation: Gillette Children's Specialty Healthcare, St Paul, MN.
authors.forename: Kelli
authors.initials: K
authors.lastname: Moberg
authors.affiliation: University of Minnesota Clinical and Translational Science Institute Biostatistical Design and Analysis Center, Minneapolis, MN.
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Menk
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Minnesota Medical School, Minneapolis, MN.
authors.forename: Jessica
authors.initials: J
authors.lastname: Cassidy
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Minnesota Medical School, Minneapolis, MN.
authors.forename: Teresa
authors.initials: T
authors.lastname: Kimberley
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Minnesota Medical School, Minneapolis, MN.
authors.forename: James R
authors.initials: JR
authors.lastname: Carey
mesh_terms: D000293:Adolescent; D002648:Child; D003071:Cognition; D005260:Female; D006225:Hand; D006801:Humans; D008297:Male; D010291:Paresis / Q000209:etiology / Q000534:rehabilitation*; D026741:Physical Therapy Modalities; D013236:Stereognosis; D020521:Stroke / Q000150:complications; D050781:Transcranial Magnetic Stimulation / Q000009:adverse effects / Q000379:methods*
keywords: Pediatrics; Rehabilitation; Safety; Stroke; Transcranial magnetic stimulation