Doorn

Every year, about 40,000 people in the Netherlands experience a stroke, and many survivors face challenges with upper limb function, which is important for daily activities. This trial evaluates the effectiveness and cost-effectiveness of continuous theta burst stimulation (cTBS) treatment to improve upper limb recovery in stroke patients admitted to rehabilitation centers. This phase III, multi-center, double-blind, randomized, and sham-controlled clinical trial aims to build on promising phase II results showing significant improvement in arm function and reduced rehabilitation stay. Participants will receive either 10 daily sessions of active cTBS or sham cTBS delivered to the contralesional primary motor cortex within 3 weeks after stroke onset. These sessions are administered over 2 weeks and are given immediately before the patients' regular physical therapy for the affected upper limb. Two groups will be compared: one receiving active cTBS and the other receiving sham cTBS. During the study, researchers will assess upper limb recovery using the Fugl-Meyer Assessment at 90 days post-stroke as the primary outcome. Additional outcomes include arm function tests, stroke impact measures, quality of life, and disability scales at 90 days and one year after stroke. Participants will be closely monitored throughout the study to track their progress and safety, with total participation lasting up to one year after stroke.