Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial

Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.

Abstract

Objective: To determine whether the addition of repetitive transcranial magnetic stimulation (rTMS) and/or constraint-induced movement therapy (CIMT) to intensive therapy increases motor function in children with perinatal stroke and hemiparesis.

Methods: A factorial-design, blinded, randomized controlled trial (clinicaltrials.gov/NCT01189058) assessed rTMS and CIMT effects in hemiparetic children (aged 6-19 years) with MRI-confirmed perinatal stroke. All completed a 2-week, goal-directed, peer-supported motor learning camp randomized to daily rTMS, CIMT, both, or neither. Primary outcomes were the Assisting Hand Assessment and the Canadian Occupational Performance Measure at baseline, and 1 week, 2 and 6 months postintervention. Outcome assessors were blinded to treatment. Interim safety analyses occurred after 12 and 24 participants. Intention-to-treat analysis examined treatment effects over time (linear mixed effects model).

Results: All 45 participants completed the trial. Addition of rTMS, CIMT, or both doubled the chances of clinically significant improvement. Assisting Hand Assessment gains at 6 months were additive and largest with rTMS + CIMT (β coefficient = 5.54 [2.57-8.51], p = 0.0004). The camp alone produced large improvements in Canadian Occupational Performance Measure scores, maximal at 6 months (Cohen d = 1.6, p = 0.002). Quality-of-life scores improved. Interventions were well tolerated and safe with no decrease in function of either hand.

Conclusions: Hemiparetic children participating in intensive, psychosocial rehabilitation programs can achieve sustained functional gains. Addition of CIMT and rTMS increases the chances of improvement.

Classification of evidence: This study provides Class II evidence that combined rTMS and CIMT enhance therapy-induced functional motor gains in children with stroke-induced hemiparetic cerebral palsy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Child
  • Combined Modality Therapy / adverse effects
  • Combined Modality Therapy / methods
  • Female
  • Hand / physiopathology
  • Humans
  • Male
  • Paresis / etiology*
  • Paresis / physiopathology
  • Paresis / rehabilitation*
  • Patient Selection
  • Physical Therapy Modalities* / adverse effects
  • Psychiatric Rehabilitation / methods
  • Quality of Life
  • Recovery of Function
  • Restraint, Physical
  • Single-Blind Method
  • Stroke / complications*
  • Stroke / physiopathology
  • Stroke Rehabilitation / adverse effects
  • Stroke Rehabilitation / methods*
  • Transcranial Magnetic Stimulation* / adverse effects
  • Transcranial Magnetic Stimulation* / methods
  • Treatment Outcome
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01189058