Stroke Clinical Trial
Official title:
Randomized Controlled Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation in Subacute Stroke
Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation
can induce significant and sustained improvements in functional outcome. However the effect
is inconsistent and difficult to predict, in particular in the subacute phase after stroke.
Although several different stimulation techniques are available, it is unknown which is
suitable for which patient.
Objectives: This study has three main objectives:
1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC,
continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on
clinical recovery in patients with subacute stroke.
2. To assess the effect of these brain stimulation techniques on brain organization with
non-invasive imaging.
3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.
Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of
3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding
stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical
therapy. Before and after the treatment period, standardized assessments of sensorimotor
function areas are obtained together with electroencephalography and functional magnetic
resonance recordings. These recordings will be used to analyze and compare the neural
effects of each treatment modality.
Clinical Implication: The results of this study might help optimize and individualize
stimulation treatment for patients with subacute stroke. It may hence facilitate the
transfer of brain stimulation therapy to routine clinical practice.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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