Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol.

Bernadette Gillick,Bryon Mueller,Kyle Rudser,Linda E Krach,Gregg Meekins,Timothy Feyma,Jeremiah Menk

doi:10.1186/s12887-015-0498-1

Abstract

BackgroundPerinatal 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/designA 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.DiscussionCombining 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.Trial registrationClinicaltrials.gov, NCT02250092Registered 18 September 2014

Highlights

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
Based on data and statistics reported by the Center for Disease Control, " Population-based studies from around the world report prevalence estimates of Cerebral Palsy (CP) ranging from 1.5 to more than 4 per 1,000 live births or children of a defined age range. " the lifetime costs of care for an individial diagnosed with cerebral palsy is over 1 million dollars. [1]
We outline the background and design of a trial with two intervention groups comparing the effects of Transcranial direct current stimulation (tDCS) on children and young adults with hemiparesis receiving constraint-induced movement therapy (CIMT)

Summary

Introduction

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). The extended cost and utilization of lengthy formal therapies such as bracing, casting, pharmacologic interventions and surgery can be painful, energy consuming and resource depleting Treatments such as constraint-induced movement therapy (CIMT) have shown significant improvements in motor function, yet the optimal electrical current dosing in this population has yet to be established [2] Impacting the recovery of a child during critical periods of development with achievement of motor milestones progressing into adulthood is imperative to positively influence an individual who faces the challenges of living with CP. Typical interhemispheric inhibition is progressively established with potent interaction between the two hemispheric motor cortices and accompanying corticospinal activation and distinct unimanual function

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