Brain Stimulation and Hand Training in Children With Hemiparesis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-10

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)

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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.

Conditions

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Pediatric Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tDCS/CIMT

Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

10 tDCS/CIMT Sessions

tDCS sham/CIMT

Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DEVICE

Interventions

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Transcranial Direct Current Stimulation (tDCS)

10 tDCS/CIMT Sessions

Intervention Type DEVICE

Placebo Comparator

Intervention Type DEVICE

Other Intervention Names

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tDCS Brain Stimulation

Eligibility Criteria

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Inclusion Criteria

1. Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
2. ≥ 10 degrees of active motion at the metacarpophalangeal joint
3. Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
4. No evidence of seizure activity within the last 2 years
5. Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
6. Ages 8-21 years
7. Able to give informed assent along with the informed consent of the legal guardian
8. 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

1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Pregnancy
7. Indwelling metal or incompatible medical devices
8. Evidence of skin disease or skin abnormalities
9. Botulinum toxin or Phenol block within \[six-months\] preceding the study

Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No