Primed low‐frequency repetitive transcranial magnetic stimulation and constraint‐induced movement therapy in pediatric hemiparesis: a randomized controlled trial

Aim The aim of this study was to determine the feasibility and efficacy of five treatments of 6 Hz primed, low‐frequency, repetitive transcranial magnetic stimulation (r TMS ) combined with constraint‐induced movement therapy ( CIMT ) to promote recovery of the paretic hand in children with congenital hemiparesis. Method Nineteen children with congenital hemiparesis aged between 8 and 17 years (10 males, nine females; mean age 10 years 10 months, SD 2 years 10 months; M anual A bility C lassification S cale levels I ‐ III ) underwent five sessions of either real r TMS ( n =10) or sham r TMS ( n =9) alternated daily with CIMT . CIMT consisted of 13 days of continuous long‐arm casting with five skin‐check sessions. Each child received a total of 10 hours of one‐to‐one therapy. The primary outcome measure was the A ssisting H and A ssessment ( AHA ) and the secondary outcome variables were the C anadian O ccupational P erformance M easure ( COPM ) and stereognosis. A W ilcoxon signed‐rank sum test was used to analyze differences between pre‐ and post‐test scores within the groups. Analysis of covariance was used to compute mean differences between groups adjusting for baseline. Fisher's exact test was used to compare individual change in AHA raw scores with the smallest detectable difference ( SDD ) of 4 points. Results All participants receiving treatment finished the study. Improvement in AHA differed significantly between groups ( p =0.007). No significant differences in the secondary outcome measures were found. Eight out of 10 participants in the r TMS / CIMT group showed improvement greater than the SDD , but only two out of nine in the sham r TMS / CIMT group showed such improvement ( p =0.023). No serious adverse events occurred. Interpretation Primed, low‐frequency r TMS combined with CIMT appears to be safe, feasible, and efficacious in pediatric hemiparesis. Larger clinical trials are now indicated.