Brain Stimulation Treatment for Improving Arm Function After Stroke A Phase III Randomized Study Using Continuous Theta Burst Stimulation Starting Within 3 Weeks of Stroke Onset

What this Trial Is About

Every year, many people in the Netherlands experience a stroke, with a significant number requiring rehabilitation due to lasting disabilities. This trial focuses on adults who have had a first-ever ischemic stroke or intracerebral hemorrhage resulting in weakness on one side of their upper limb. Researchers aim to evaluate the effectiveness and cost-effectiveness of continuous theta burst stimulation cTBS to improve arm function after stroke, building on earlier findings that showed promising recovery benefits. Participants will receive 10 daily sessions of cTBS treatment over two weeks, targeting the brain area controlling the unaffected arm side. This treatment is given immediately before regular physical therapy for the affected arm. The study compares active cTBS with a sham placebo version, using special coils to deliver the stimulation. The trial is double-blind and randomized, meaning neither patients nor researchers know which treatment is given until the study ends. During the study, participants arm function will be assessed using various tests at 90 days and one year after their stroke. These include the Fugl-Meyer Assessment, Action Research Arm Test, and others measuring hand use, daily activities, and quality of life. Researchers will also monitor medical care use and productivity costs. The study lasts up to one year, with evaluations designed to track recovery progress and treatment impact over time.

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