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.

Design: Phase 1 randomized, double-blinded, placebo-controlled pretest/posttest trial.

Setting: University academic facility and pediatric specialty hospital.

Participants: 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.

Interventions: Subjects were randomized to 1 of 2 groups: either real rTMS plus mCIMT (n = 10) or sham rTMS plus mCIMT (n = 9).

Main outcome measures: 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.

Trial registration: ClinicalTrials.gov NCT01104064.

Keywords: Pediatrics; Rehabilitation; Safety; Stroke; Transcranial magnetic stimulation.

Conflict of interest statement

No author has a conflict of interest.

Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Study Design. Screening was followed by a 2-day series of Pretesting: Imaging, Physician Assessment, Cognitive and Motor Testing. Repetitive transcranial magnetic stimulation sessions (light blocks) were 20 minutes total; priming for 10 minutes at 6 Hz at 90% resting motor threshold (RMT), followed by low-frequency 1-Hz rTMS for 10 minutes at 90% RMT. Modified constraint-induced movement therapy (mCIMT) (dark blocks) was performed for 2 hours with 1:1 therapist-subject treatments. The constraint cast was applied on treatment day 2, and removed on treatment day 10 (13 days total wear including weekends).

Figure 2

Consolidated Standards of Reporting Trials (CONSORT) Diagram. MEP, Motor Evoked Potential. rTMS, repetitive Transcranial Magnetic Stimulation. mCIMT, modified constraint-induced movement therapy.

Figure 3

Accuracy Index of the Unaffected Hand. Means for rTMSreal/mCIMT group represented by bold orange line pre to posttest, and rTMSsham/mCIMT group in purple. Individuals in either group noted by thin lines of corresponding colors.