Brain Stimulation and Hand Training in Children With Hemiparesis

Study Overview
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Brief Summary
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Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain. Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques. Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery. Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability. To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)

Detailed Description
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We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.

Official Title
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Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis

Conditions
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Pediatric Hemiparesis

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)
* Device: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis ≥ 10 degrees of active motion at the metacarpophalangeal joint Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence No evidence of seizure activity within the last 2 years Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres Ages 8-21 years Able to give informed assent along with the informed consent of the legal guardian Children who have had surgeries, which may influence motor function eg- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table. Exclusion Criteria: Metabolic Disorders Neoplasm Epilepsy Disorders of Cellular Migration and Proliferation Acquired Traumatic Brain Injury Pregnancy Indwelling metal or incompatible medical devices Evidence of skin disease or skin abnormalities Botulinum toxin or Phenol block within [six-months] preceding the study

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 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 |
| --- | --- |
| Active Comparator: tDCS/CIMT<br>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 10 tDCS/CIMT Sessions<br>* Other names: Brain Stimulation;|
| Placebo Comparator: tDCS sham/CIMT<br>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. | Device: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Assisting Hand Assessment (AHA) | Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. | 2 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Canadian Occupational Performance Measurement (COPM) | The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the average satisfaction score, ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. | 2 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Hemiparesis, Stroke, Non-Invasive Brain Stimulation, Transcranial Direct Current Stimulation, Constraint-Induced Movement Therapy, Diffusion Tensor Imaging, Congenital Hemiparesis, Bimanual Therapy