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.

Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide

“…A confidential family feedback form, filled out anonymously by the child and caregiver together, can provide helpful information (Appendix G in Supplementary Material). Additionally, formal follow-up at established time points after the study allows long-term assessment of participant status and interpretation of the potential longitudinal effects that NIBS may have ( 91 ).…”

Documenting change with the Canadian Occupational Performance Measure for children with cerebral palsy

“…[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] We identified one study where the COPM goals were rescored at 21 to 57 months after an upper extremity intervention in children with hemiplegic cerebral palsy (CP); the study found that in 5 of 13 individuals, the COPM goals were no longer relevant. 28 A second study assessed the COPM 12 to 43 months after a rehabilitation intervention for whiplash and showed that the long-term impact of the rehabilitation programme was maintained. 29 Evaluating the capacity of the COPM to measure clinically 'important' change in individualized goals over longer durations would provide evidence for a tool that can be integrated into long-term research studies and clinical practice, a necessary and crucial step for assessing longterm impact of interventions for people with chronic conditions.…”

“…It is typically used over a short timeframe, from 2 weeks to 1 year 11–27 . We identified one study where the COPM goals were rescored at 21 to 57 months after an upper extremity intervention in children with hemiplegic cerebral palsy (CP); the study found that in 5 of 13 individuals, the COPM goals were no longer relevant 28 . A second study assessed the COPM 12 to 43 months after a rehabilitation intervention for whiplash and showed that the long‐term impact of the rehabilitation programme was maintained 29 …”

EMG breakthrough during cortical silent period in congenital hemiparesis: a descriptive case series

“…A total of seven children (4 females and 3 males) with congenital hemiparesis (mean age = 13 years; age range = 10---16 years) included in this study were enrolled in a transcranial direct current stimulation/constraint induced movement therapy study (ClinicalTrial.gov NCT02250092). 19 This report details baseline motor threshold and CSP duration. Informed consent and assent were obtained from all legal guardians and the children for study participation and for publication in this case series.…”

“…The EMG breakthrough activity has been reported in healthy adults. 5,18,19 However, no study, to our knowledge, has reported the EMG breakthrough activity in children with congenital hemiparesis.…”