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Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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This single-center, single-blind, randomized, sham-controlled clinical trial will include 60 patients aged \>45 years who are within 3 months of a first-ever middle cerebral artery ischemic stroke. Participants will be randomized into four groups: coupled TBS (contralesional cTBS followed by ipsilesional iTBS), cTBS plus sham iTBS, sham cTBS plus iTBS, or sham TBS. TBS will be delivered over the primary motor cortex for 10 sessions over 2 weeks. Stimulation intensity will be set at 80% of the resting motor threshold determined using EMG-guided motor evoked potentials. Each cTBS and iTBS application will consist of 600 pulses. All participants will additionally receive standardized conventional rehabilitation for at least 4 weeks. The primary outcome will be upper-extremity motor recovery assessed using the motor domain of the Fugl-Meyer Assessment. Secondary outcomes will include lower-extremity motor recovery, spasticity, sensory function, cortical excitability, functional ambulation, activities of daily living, and stroke-specific quality of life. Assessments will be performed at baseline, after the 2-week intervention, and at 1-month post-treatment follow-up.
Trial Details
NCT Number NCT07834333
Lead Sponsor Ankara Etlik City Hospital
Conditions
(from sponsor)
Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov