Clinical Trial: Enhancing Motor Plasticity After Perinatal Stroke Using tDCS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Enhancing Developmental Motor Plasticity After Perinatal Stroke With Transcranial Direct Current Stimulation

Brief Summary:

The purpose of this study is to test tDCS (transcranial direct current stimulation), a type of non-invasive brain stimulation, to determine whether it can improve motor function in children with perinatal stroke and hemiparesis. Children 6-18 years with imaging-confirmed perinatal stroke and functional motor impairment will be recruited. Children will be randomized (1:1) to receive sham or tDCS (20 minutes daily) during daily intensive, goal-directed motor learning therapy (90 minutes). Motor outcomes will be repeated at baseline, 1 week, and 2 months.

Aim 1: Establish the ability of tDCS to safely enhance motor learning in children with perinatal stroke.

Hypothesis 1: tDCS is safe and well tolerated in children.

Hypothesis 2: Contralesional, cathodal tDCS increases motor functional gains measured by AHA at 2 months in children with perinatal stroke.


Detailed Summary:

Methods details not included elsewhere

Study: Randomized, sham-controlled, double blind, phase II clinical trial.

Patient Population. All children will be recruited through the Alberta Perinatal Stroke Project (APSP); a large population-based perinatal stroke research cohort based at Alberta Children's Hospital and directed by the PI. Prospective APSP ascertainment since 2007 is combined with retrospective enrolment (1992-2007) with comprehensive International Classification of Disease codes (ICD-9, ICD-10)237 and institutional databases. These are fully characterized patients with confirmed diagnosis by modern neuroimaging assessed in person in standardized APSP clinics. Recruitment will occur randomly from the population of all children meeting the criteria below.

Inclusion/exclusion criteria - see below

Data Collection and Management. Candidate APSP families will be contacted with review of consent/assent forms. Families residing outside Calgary will have equal opportunity to participate through existing APSP support systems. All complimentary data from existing studies is extractable from the APSP database (demographics, imaging, risk factors, outcomes).13 Neuroimaging data will be managed through the ACH Pediatric Neuroimaging Laboratory according to institutional protocols. Neurophysiology data will be collected at the ACH Pediatric TMS Laboratory and securely stored centrally.107 The institutional Clinical Research Unit is a database management unit designed for clinical research and currently houses all APSP studies and trials. The research database platform encompasses data capture utilities, management tools, and security measures (Health Canada-compliant). Methods will adhere to the CONSORT guidelines and the stud
Sponsor: University of Calgary

Current Primary Outcome: Change from baseline in the Assisting Hand Assessment (AHA) at 8 weeks [ Time Frame: 8 weeks ]

This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP.This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in children within our age range For more details about this measures please refer to the published literature.


Original Primary Outcome:

  • Change from baseline in the Assisting Hand Assessment (AHA) at 1 week [ Time Frame: Baseline, 1 week ]
    This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP.This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in children within our age range For more details about this measures please refer to the published literature.
  • Change from baseline in the Assisting Hand Assessment (AHA) at 8 weeks [ Time Frame: 8 weeks ]
    This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP.This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in children within our age range For more details about this measures please refer to the published literature.


Current Secondary Outcome:

  • tDCS Safety and Tolerability evaluation (TST) [ Time Frame: Each day following the tDCS treatment (10x) ]
    Adapted from a published safety consensus statements and child-friendly tolerability evaluations for non-invasive brain stimulation. Measure will capture all possible adverse events including severity and duration, rank tDCS sessions across common childhood experiences, and evaluate sham effectiveness. For more details about this measures please refer to the published literature.
  • Change from baseline in the Canadian Occupational Performance Measure (COPM) at 1 week [ Time Frame: Baseline, 1 week ]
    Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities. OT-guided goal setting scores 3-5 individualized, realistic goals and ranks them on a scale of 1-10 for both satisfaction and performance. The same assessor applies the tool at post follow-ups without reminding the subject of previous scores. Such subjective measures are highly clinically relevant to assess perceived gains in children. COPM is validated for our population.
  • Change from baseline in the Canadian Occupational Performance Measure (COPM) at 8 weeks [ Time Frame: 8 weeks ]
    Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities. OT-guided goal setting scores 3-5 individualized, realistic goals and ranks them on a scale of 1-10 for both satisfaction and performance. The same assessor applies the tool at post follow-ups without reminding the subject of previous scores. Such subjective measures are highly clinically relevant to assess perceived gains in children. COPM is validated for our population.


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: June 16, 2014
Date Started: May 2014
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015