Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

Study Overview
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Brief Summary
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The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).

Official Title
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Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: active transcranial direct current stimulation
* Behavioral: Motor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions. Exclusion Criteria: Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator) True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen Current use of medications known to lower the seizure threshold Previous episode of unprovoked neurocardiogenic syncope Indwelling metal or incompatible medical devices Centrally-acting medications including anti-seizure medications Evidence of scalp disease or skin abnormalities Current medical illness unrelated to CP High motor ability in affected arm (i.e. no asymmetry in scores of hand function) Severe spasticity Lack of asymmetry in hand function Orthopedic surgery in affected arm Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period Currently receiving intrathecal baclofen History of broken arm (either arm) 1 year prior to study enrollment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS + motor training<br>In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. | Device: active transcranial direct current stimulation<br>* Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.<br>Behavioral: Motor training<br>* Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.<br>|
| Experimental: Sham tDCS + motor training<br>In this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation. | Behavioral: Motor training<br>* Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Assisting Hand Assessment | Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities. | Day before intervention begins, compared to day after intervention ends (approximately 1 week) | 
| Changes in the Box and Blocks test | Investigators will measure changes in the movement speed of the hands. | Day before intervention begins, compared to day after intervention ends (approximately 1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Motor-evoked Potential assessment | Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week). | Day before intervention begins, compared to day after intervention ends (approximately 1 week) |