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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Service de Neurorééducation, Unversity Hospital
Geneva, Switzerland
Change in compound motor score slope at week 4
The Fugl Meyer motor assessment (FMA), the Nine Hole Peg test (expressed as pegs per minute), and the Jamar dynamometer strength of the affected arm are normalized to the healthy arm and averaged to a compound motor score. This score is obtained twice before treatment (at weeks -1 and 0 relative to treatment start), and twice after treatment (at weeks 4 and 8). Primary outcome measure is the change in slope from week 0 to 4 as compared to the slope between week -1 and 0.
Time frame: week 4 after treatment start
Change in alpha-band coherence between the affected motor cortex and the rest of the brain
Calculated from electroencephalography recordings
Time frame: Week 4
Change in Fugl Meyer Upper Extremity Motor Score at week 4
Time frame: Week 4
Change in Fugl Meyer Upper Extremity Motor Score at week 8
Time frame: Week 8
Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain
Time frame: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Time frame: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Time frame: Week 8
Number of adverse events
Time frame: Week 4
Number of adverse events
Time frame: Week 8
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