Abstract
Background: Perinatal stroke occurs in more than 1 in 2,500 live births and resultant congenital hemiparesis necessitates investigation into interventions which may improve long-term function and decreased burden of care beyond current therapies (http://www.cdc.gov/ncbddd/cp/data.html). Constraint-Induced Movement Therapy (CIMT) is recognized as an effective hemiparesis rehabilitation intervention . Transcranial direct current stimulation as an adjunct treatment to CIMT may potentiate neuroplastic responses and improve motor function. The methodology of a clinical trial in children designed as a placebo-controlled, serial -session, non-invasive brain stimulation trial incorporating CIMT is described here. The primary hypotheses are 1) that no serious adverse events will occur in children receiving non-invasive brain stimulation and 2) that children in the stimulation intervention group will show significant improvements in hand motor function compared to children in the placebo stimulation control group. Methods/design: A randomized, controlled, double-blinded clinical trial. Twenty children and/or young adults (ages 8-21) with congenital hemiparesis, will be enrolled. The intervention group will receive ten 2-hour sessions of transcranial direct current stimulation combined with constraint-induced movement therapy and the control group will receive sham stimulation with CIMT. The primary outcome measure is safety assessment of transcranial direct current stimulation by physician evaluation, vital sign monitoring and symptom reports. Additionally, hand function will be evaluated using the Assisting Hand Assessment, grip strength and assessment of goals using the Canadian Occupational Performance Measure. Neuroimaging will confirm diagnoses, corticospinal tract integrity and cortical activation. Motor cortical excitability will also be examined using transcranial magnetic stimulation techniques. Discussion: Combining non-invasive brain stimulation and CIMT interventions has the potential to improve motor function in children with congenital hemiparesis beyond each intervention independently. Such a combined intervention has the potential to benefit an individual throughout their lifetime.
Original language | English (US) |
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Article number | 178 |
Journal | BMC Pediatrics |
Volume | 15 |
Issue number | 1 |
DOIs | |
State | Published - Nov 12 2015 |
Bibliographical note
Funding Information:Acknowledgments We wish to acknowledge Sally Jones for her critical revisions of this manuscript. We thank also the families and children involved in our initial pilot testing to establish this protocol, and the future participants and families to come.
Funding Information:
This project is supported by the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institutes of Child Health and Development K01 Award (#HD078484-01A1), the Cerebral Palsy. Foundation and the Foundation for Physical Therapy Magistro Family Grant. The project described was also supported in part by Award Number UL1TR000114 and KL2TR000113 from the National Center for Advancing Translational Sciences (NCATS) of the NIH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the NIH. Study data were collected and managed using REDCap electronic data capture tools hosted at the University of Minnesota. The University of Minnesota Center for Magnetic Resonance Research funding supported the imaging work number P41 EB015894.
Publisher Copyright:
© 2015 Gillick et al.
Keywords
- Constraint-induced movement therapy
- Electrical stimulation
- Hand function
- Hemiparesis
- Non-invasive brain stimulation
- Pediatrics