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

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 study will be registered prior to consent of the first patient (www.clinicaltrials.gov).