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Brain Stimulation and Hand Training in Children With Hemiparesis

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ClinicalTrials.gov Identifier: NCT02250092
Recruitment Status : Active, not recruiting
First Posted : September 26, 2014
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
Cerebral Palsy International Research Foundation
Foundation for Physical Therapy, Inc.
NIH K01 Career Development Award
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

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)


Condition or disease Intervention/treatment Phase
Pediatric Hemiparesis Device: Transcranial Direct Current Stimulation (tDCS) Device: Placebo Comparator Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis
Study Start Date : December 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: tDCS/CIMT
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
Device: Transcranial Direct Current Stimulation (tDCS)
10 tDCS/CIMT Sessions
Other Names:
  • tDCS
  • Brain Stimulation

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



Primary Outcome Measures :
  1. Assisting Hand Assessment [ Time Frame: Baseline, 2 weeks and 6 months ]
    Videotaped performance during a bimanual age-appropriate activity of change from baseline to posttest and followup sessions of bimanual performance using an assessment of assisting hand performance during bimanual activities.


Secondary Outcome Measures :
  1. Canadian Occupational Performance Measurement [ Time Frame: Baseline, 2 weeks and 6 months ]
    Subject survey tool of change from baseline to posttest and followup sessions by participant declaration of goals with assessment of personal satisfaction and performance compared to baseline.


Other Outcome Measures:
  1. Subject Symptom Assessment [ Time Frame: Baseline, 2 weeks and 6 months ]
    Questionnaire- Assessment of change from baseline to during-session-posttest and follow up using a detailed assessment of subject symptoms as relate to behavioral and non-invasive brain stimulation interventions.



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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250092


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Cerebral Palsy International Research Foundation
Foundation for Physical Therapy, Inc.
NIH K01 Career Development Award
Investigators
Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02250092     History of Changes
Other Study ID Numbers: 1408M53169
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cerebral Palsy
Hemiparesis
Stroke
Non-Invasive Brain Stimulation
Transcranial Direct Current Stimulation
Constraint-Induced Movement Therapy
Diffusion Tensor Imaging
Congenital Hemiparesis
Bimanual Therapy

Additional relevant MeSH terms:
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms