Enhancing Motor Plasticity After Perinatal Stroke Using tDCS (NCT02170285) | Clinical Trial Compass
CompletedPhase 2
Enhancing Motor Plasticity After Perinatal Stroke Using tDCS
Canada23 participantsStarted 2014-05
Plain-language 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.
Who can participate
Age range6 Years – 18 Years
SexALL
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Inclusion criteria
✓. Symptomatic hemiparetic CP (Pediatric Stroke Outcome Measure (PSOM) \>0.5) AND Manual Abilities Classification System (MACS) grade I-IV AND child/parent perceived limitations
✓. Clinical and MRI-confirmed perinatal stroke syndrome (NAIS, APPIS, PVI)
✓. Active wrist extension \>20 degrees, finger extension \>10 degrees
✓. Can lift the affected arm 15 cm above a table surface and grasp light objects
✓. Term birth (\>36 weeks) and current age 6 - 18 years
✓. Informed consent
Exclusion criteria
✕. Other neurological disorder not related to perinatal stroke
✕. Multifocal perinatal stroke
✕. Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
✕. Severe spasticity in the affected limb (Modified Ashworth Scale \>3)
What they're measuring
1
Change from baseline in the Assisting Hand Assessment (AHA) at 8 weeks