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

Abstract

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 (rTMS) 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; Manual Ability Classification Scale levels I-III) underwent five sessions of either real rTMS (n=10) or sham rTMS (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 Assisting Hand Assessment (AHA) and the secondary outcome variables were the Canadian Occupational Performance Measure (COPM) and stereognosis. A Wilcoxon 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 rTMS/CIMT group showed improvement greater than the SDD, but only two out of nine in the sham rTMS/CIMT group showed such improvement (p=0.023). No serious adverse events occurred.

Interpretation: Primed, low-frequency rTMS combined with CIMT appears to be safe, feasible, and efficacious in pediatric hemiparesis. Larger clinical trials are now indicated.

Trial registration: ClinicalTrials.gov NCT01104064.

Figure 1

Consolidated standards of reporting trials (CONSORT) diagram. MRI, magnetic resonance imaging; HIPAA, Health Insurance Portability and Accountability Act; MEP, motor evoked potential; rTMS, repetitive transcranial magnetic stimulation; CIMT, constraint-induced movement therapy.

Figure 2

Effect of primed low-frequency repetitive transcranial magnetic stimulation (rTMS) and constraint-induced movement therapy (CIMT) on primary and secondary outcome measures. Primary outcome measure: Assisting Hand Assessment (AHA). (a) Raw score; (b) scaled score. Significant differences noted in both scoring types between groups. Secondary outcome measures: Canadian Occupational Performance Measure (COPM). (c) Performance score; (d) satisfaction score; (e) stereognosis; and (f) force. There were trends toward improvements in both groups from pre-test to post-test.