This Phase 3 study will evaluate whether lesion network mapping-guided continuous theta burst stimulation (cTBS) can improve recovery after acute ischemic stroke. The treatment uses each participant's brain imaging to identify individualized stimulation targets related to stroke symptoms. Participants will receive either active cTBS or a sham procedure in addition to standard stroke care. The study will assess whether this personalized brain stimulation approach improves functional recovery and is safe for patients after ischemic stroke.
Age 18-80 years.
Ischemic stroke onset within the past 14 days.
Unilateral, supratentorial ischemic stroke confirmed by CT or MRI.
Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Contraindications to TMS (e.g. cranial metallic foreign bodies, cardiac pacemaker, implanted drug pump, cochlear implant).
History of epilepsy or seizure, intracranial hypertension, tumor, or other serious neurological disease.
Midline shift or parenchymal mass effect on cranial CT or other imaging.
CT or MRI evidence of bilateral acute cerebral infarction or infratentorial acute infarction (brainstem or cerebellum).
Parallel
LNM-navigated cTBS
DeviceIndividualized treatment targets are defined by outlining each patient's acute infarct lesion on MRI and projecting it onto a normative functional connectivity map to identify symptom-relevant network nodes within sensorimotor regions. Treatment is delivered over seven consecutive days using a figure-8 coil guided by neuronavigation. cTBS consists of 3-pulse bursts at 50 Hz, repeated at 5 Hz, for a total of 600 pulses over 40 seconds, delivered at 80% of the resting motor threshold (RMT).
Sham cTBS
DeviceSham stimulation follows the same MRI-based lesion mapping, target selection, neuronavigation workflow, coil positioning, timing, acoustic noise, and treatment course as the active group, but uses a sham figure-8 coil that mimics stimulation without generating a significant magnetic field. This design helps maintain blinding of participants and assessors while ensuring that no effective magnetic stimulation is delivered.
Proportion of patients achieving mRS 0-2
Proportion experiencing serious adverse events (SAEs)
Proportion experiencing serious adverse events (SAEs), including seizures
Distribution shift in modified Rankin Scale (mRS) score
Distribution shift in modified Rankin Scale (mRS) scores at Day 90 post-randomization. The mRS is an ordinal disability scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Higher scores indicate worse functional outcome.
Proportion of patients achieving mRS 0-1
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) total score at Day 7
Change in National Institutes of Health Stroke Scale (NIHSS) total score from baseline to Day 7 post-randomization. The NIHSS total score ranges from 0 to 42; higher scores indicate a more severe neurological deficit and worse outcome. Change is calculated as the Day 7 score minus the baseline score. A negative change indicates improvement.
Change from baseline in Fugl-Meyer Assessment of Motor Recovery after Stroke motor score at Day 7
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke motor score from baseline to Day 7 post-randomization. The Fugl-Meyer Assessment motor score ranges from 0 to 100, including an upper extremity motor score ranging from 0 to 66 and a lower extremity motor score ranging from 0 to 34. Higher scores indicate better motor recovery and less motor impairment. Change is calculated as the Day 7 score minus the baseline score; a positive change indicates improvement.
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