Repetitive Transcranial Magnetic Stimulation/Behavioral Intervention Clinical Trial: Long-Term Follow-Up of Outcomes in Congenital Hemiparesis

Abstract

Objective: The purpose of this study was to examine long-term outcomes of nonpharmacological intervention in children and adolescents with stroke utilizing repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex combined with constraint- induced movement therapy (CIMT) to improve motor function in the paretic hand. Outcome measures included function, satisfaction, and medical status review.

Methods: Fourteen of the original 19 participants (74%) from our rTMS/CIMT clinical trial (real rTMS+CIMT, n = 8; and sham rTMS+CIMT, n = 6) were evaluated. The median age of the subjects at follow up was 13.4 years (range 11-20 years old, 50% male). Median time to follow-up was 47.5 months (range 21-57 months). Descriptive statistics were conducted using frequencies and counts. Motor performance was measured using the Assisting Hand Assessment (AHA) and Canadian Occupational Performance Measure (COPM). Satisfaction was reported with use of the COPM and TMS Tolerance Survey. Open-ended interview was conducted for feedback on study experience and subjective perspectives of current functional status.

Results: Overall, seven of eight individuals who received real rTMS and five of six individuals who received sham rTMS maintained or improved AHA scores. Six of 14 participants reported new onset of co-occurring conditions (four individuals in the real rTMS group, two individuals in the sham rTMS group). The majority (86%) of participants reported study satisfaction. Review of medical status revealed co-occurring conditions including: Epilepsy, obsessive-compulsive disorder, anxiety, depression, unspecified mood disorder, and undiagnosed inattentiveness.

Conclusions: Long-term outcomes of rTMS/CIMT in pediatric stroke were investigated. Variability in performance and unattributed symptoms were noted. Considering the prevalence of co-occurring conditions in children and adolescents with stroke, new-onset symptoms were not attributed to original intervention. With the small sample size, the impact of rTMS on long-term outcomes cannot be fully determined from these data. Characterizing long-term outcomes through performance, participant perspectives, and medical status allows comprehensive assessment of rTMS/CIMT intervention efficacy.

Trial registration: ClinicalTrials.gov NCT02091687.

FIG. 1.

CONSORT flow diagram delineating follow-up and original group assignment. CONSORT, Consolidated Standards of Reporting Trials; rTMS, repetitive transcranial magnetic stimulation; CIMT, constraint-induced movement therapy; HIPAA, Health Insurance Portability and Accountability Act; MR, medical record.

FIG. 2.

Time since study participation in months. Solid bars represent each individual in the real rTMS/CIMT group; open bars represent each individual in the sham rTMS/CIMT group. rTMS+CIMT, repetitive transcranial magnetic stimulation and constraint-induced movement therapy.

FIG. 3.

Change in bimanual performance at three testing points (pretrial, posttrial, and long-term follow up) using the Assisting Hand Assessment (AHA) and logit-based 0-100 AHA-units. Solid lines with circles denoting testing points represent individuals in the real rTMS+CIMT group (n = 8) and dashed lines with squares denoting testing points represent individuals in the sham rTMS+CIMT group (n = 6). Time in days (d) or months (m) at each testing point is reflected with pretrial = 0d, posttrial = 13d, and long-term follow-up as indicated by month (range 21–57 months). CIMT, constraint-induced movement therapy; rTMS, repetitive transcranial magnetic stimulation.