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Brain Stimulation and Hand Training in Children With Hemiparesis

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ClinicalTrials.gov Identifier: NCT02250092
Recruitment Status : Completed
First Posted : September 26, 2014
Results First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Collaborators:
Cerebral Palsy International Research Foundation
Foundation for Physical Therapy, Inc.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Minnesota

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.

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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
Actual Study Start Date : December 31, 2014
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : July 10, 2017

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. Change in Assisting Hand Assessment (AHA) [ Time Frame: 2 weeks, 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in Canadian Occupational Performance Measurement (COPM) [ Time Frame: 2 weeks, 6 months ]
    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.


Other Outcome Measures:
  1. Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months [ Time Frame: 2 weeks, 6 months ]
    The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.



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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
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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
Cerebral Palsy International Research Foundation
Foundation for Physical Therapy, Inc.
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02250092    
Other Study ID Numbers: 1408M53169
First Posted: September 26, 2014    Key Record Dates
Results First Posted: August 18, 2020
Last Update Posted: August 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
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:
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Paresis
Neurologic Manifestations
Nervous System Diseases