Improving Upper Limb Movement After Stroke Using Multifocal Theta-Burst Brain Stimulation and Tablet-Based Training A Randomized, Sham-Controlled Study

What this Trial Is About

Stroke is a leading cause of long-term disability, with many survivors experiencing ongoing weakness and reduced control of one arm that affects daily activities and quality of life. Recovery depends on the brains ability to reorganize, involving connections between the primary motor cortex M1 and the parietal cortex PC. This study investigates whether a new brain stimulation method, intermittent theta-burst stimulation iTBS, targeting both these brain areas with structured motor training can improve arm function after stroke. The trial is a single-center, randomized, sham-controlled, triple-blind study involving 36 individuals with chronic stroke-related upper limb impairment. Participants will be randomly assigned to receive either active multifocal iTBS or sham stimulation before motor training using a tablet-based device called REAtouchLite 2, which supports goal-directed arm movements. The intervention includes two days of stimulation followed by 45 minutes of motor training each day. Additionally, 10 healthy participants will perform the same motor training without brain stimulation to provide reference data. Participants will attend six visits over about 10 days, undergoing motor performance assessments with the tablet and a clinical motor scale Fugl-Meyer Assessment for Upper Extremity. Brain activity will be measured using resting-state EEG before and after the intervention to evaluate changes in brain connectivity. The main outcome is improvement in motor performance from baseline to one week post-intervention. Secondary outcomes include short-term learning, retention of motor skills, movement quality changes, and brain connectivity changes.

Multifocal Theta-Burst Stimulation to Enhance Upper Limb Motor Recovery After Stroke (INSPIRE)