Research Report
Population: Pediatric
Tonya L Rich, MA, OTR/L, PhDs, PhD Graduate Student, University of Minnesota rich1038@umn.edu
Timothy Feyma, MD, Pediatric Neurologist/Investigator, Gillette Children’s Specialty Healthcare tfeyma@gillettechildrens.com
Linda Krach, MD, President Courage Kenny Rehabilitation/Investigator, Courage Kenny Rehabilitation linda.krach@allina.com
Bernadette Gillick, PhD, MSPT, PT, Assistant Professor/Principal Investigator, University of Minnesota gillick@umn.edu
Keywords: Plasticity, Non-Invasive Brain Stimulation, Pediatrics, Stroke
Purpose: Human clinical studies now incorporate neuromodulatory interventions to potentiate motor recovery after adult stroke. Studies are now investigating the pediatric population with non-surgical brain stimulation techniques repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS)).1,2 The purpose of this study is to investigate child and caregiver perspectives following neuromodulatory clinical trials.
Number of Subjects: 73
Materials/Methods: Data from 3 neuromodulatory clinical trials collectively representing 73 participants, ages 8-21, n= 48 children with hemiparesis, n=26 typically developing children. Measures included satisfaction and willingness to re-enroll (adapted from Garvey3) and open-ended surveys. Satisfaction was measured on an ordinal scale of 1-10. Clinical trials varied in duration. Trial 1: A 10-day rTMS/constraint induced movement therapy (CIMT) (n=18). Trial 2: Single session evaluating tDCS safety (n=13). Trial 3: Single session comparing two methods to localize the motor cortex (n=42).
Results: Trial 1: Satisfaction: Comparable between groups sham rTMS/CIMT (n=9; 8.9 ± 2) and real rTMS/CIMT (n=9; 8.9 ± 2). Re-enrollment: Sham rTMS/CIMT 86%, real rTMS/CIMT 88%. Drop out rate: 0. Trial 2: Satisfaction: Comparable between groups with an average: 8.2 ± 1.9. Re-enrollment: 92%. Drop out rate: 1. 4 Trial 3: All children (n=37) and families reported the study met their expectations (100%). Drop out rate: 1. Open-ended feedback themes were similar among all studies focused on awareness of disability, hope for improvements, and testing experience.
Conclusions: These findings reflect positive observations from children and caregivers in pediatric neuromodulatory clinical trials. Integrating this feedback facilitates family-centered research design.
Clinical Relevance: Successful participant retention for full study completion requires continued integration of formal family-centered feedback. Survey methods for eliciting feedback allow for rich guidance from families to steer future study design improving clinical feasibility and explore salience for children.
References: 1. Gillick B, Krach L, Feyma T, et al. Primed low-frequency repetitive transcranial magnetic stimulation and constraint-induced movement therapy in pediatric hemiparesis: A randomized controlled trial. Dev Med Child Neurol. 2014;56(1):44-52. doi: 10.1111/dmcn.12243. 2. Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: A randomised trial. Lancet Neurology. 2008;7(6):507-513. 3. Garvey MA, Kaczynski KJ, Becker DA, Bartko JJ. Subjective reactions of children to single-pulse transcranial magnetic stimulation. J Child Neurol. 2001;16(12):891-89. 4.Gillick B, Feyma T, Menk J, et al. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: Randomized controlled preliminary study. Phys Ther. 2014. doi: 10.2522/ptj.20130565.
Citation:
Rich, Tonya L, MA, OTR/L, PhDs; Feyma, Timothy , MD; Krach, Linda E, MD; Gillick, Bernadette T, PhD, MSPT, PT. Non-Surgical Brain Stimulation Studies in Children With and Without Stroke: The Child and Caregiver’s Perspective.. Poster Presentation. IV STEP Conference, American Physical Therapy Association, Columbus, OH, July 17, 2016. Online. https://u.osu.edu/ivstep/poster/abstracts/071_rich-et-al/