Brain Stimulation and Hand Training in Children With Hemiparesis

Active, not recruiting

Phase 1/2 Results N/A

Update History

4 Oct '17 acronym not implemented.
The Summary of Purpose was updated.
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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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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 will investigate 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.
The description was updated.
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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.
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None.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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
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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
A location was updated in Minneapolis.
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The overall status was removed for University of Minnesota.
25 Jun '15
Trial name was updated.
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Brain Stimulation and Hand Training in Children With Hemiparesis
7 Feb '15
A location was updated in Minneapolis.
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The overall status was removed for University of Minnesota.
A location was updated in St. Paul.
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The overall status was updated to "Recruiting" at Gillette Children's Specialty Healthcare.