A Phase 3 interventional study of LNM-navigated cTBS and Sham cTBS in Ischemic Stroke, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Treatment
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.
Acute ischemic stroke often leads to persistent motor impairment despite standard medical treatment and rehabilitation. The early post-stroke period may represent an important window for modulating brain network plasticity and promoting recovery. Continuous theta burst stimulation (cTBS), a patterned form of repetitive transcranial magnetic stimulation, can modulate cortical excitability over a short stimulation period and may support recovery when applied to clinically relevant motor networks.
This study evaluates a personalized neuromodulation approach based on lesion network mapping. For each participant, the acute infarct lesion is identified on clinical brain imaging and mapped to a reference functional connectome to estimate lesion-associated networks. Candidate stimulation targets are selected from symptom-relevant cortical network nodes, with consideration of accessibility, safety, and electric-field modeling. Neuronavigation is used to guide coil placement and maintain targeting accuracy.
Active treatment consists of lesion network mapping-guided cTBS delivered to individualized cortical targets using a figure-8 coil under neuronavigation. Sham stimulation follows the same imaging-based target selection, electric-field modeling, positioning, and procedural workflow, but uses a sham coil designed to mimic the sensory and acoustic features of stimulation without delivering a therapeutic magnetic field. This approach is intended to maintain blinding while isolating the effect of active stimulation.
This Phase 3 trial evaluates the efficacy and safety of individualized lesion network mapping-guided cTBS for recovery after acute ischemic stroke.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 584 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive active lesion network mapping (LNM)-navigated continuous theta burst stimulation (cTBS).
Device: LNM-navigated cTBS
Participants receive sham LNM-navigated cTBS using procedures that mimic the active intervention.
Device: Sham cTBS
Individualized 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 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
Time frame: Day 90 post-randomization
Proportion experiencing serious adverse events (SAEs)
Proportion experiencing serious adverse events (SAEs), including seizures
Time frame: Within 90 days post-randomization
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.
Time frame: Day 90 post-randomization
Proportion of patients achieving mRS 0-1
Time frame: Day 90 post-randomization
Proportion of Participants With Early Neurological Improvement at Day 7
Proportion of participants with early neurological improvement, defined as a decrease of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) total score from baseline to Day 7 post-randomization or an NIHSS total score of 0-1 at Day 7. The NIHSS total score ranges from 0 to 42, with higher scores indicating more severe neurological deficits. Participants meeting either criterion will be classified as having early neurological improvement.
Time frame: Day 7 post-randomization
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.
Time frame: Day 7 post-randomization
Barthel Index for Activities of Daily Living score at Day 90
Barthel Index for Activities of Daily Living score at Day 90 post-randomization. The Barthel Index assesses independence in 10 activities of daily living and mobility activities. Total scores range from 0 to 100; higher scores indicate greater independence and better functional outcome.
Time frame: Day 90 post-randomization
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Index Score at Day 90
EQ-5D-5L utility index score at Day 90 post-randomization. The EQ-5D-5L assesses health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels of severity for each dimension. The resulting health states are converted into a utility index score using the applicable EQ-5D-5L value set. Higher scores indicate better health-related quality of life.
Time frame: Day 90 post-randomization
Early neurological deterioration
Proportion of patients with neurological deterioration (defined as a ≥4-point increase in NIHSS score) within 7 days post-randomisation.
Time frame: 7 days post-randomisation
Proportion of participants with insomnia
The proportion of participants with insomnia reported within 7 days after randomization.
Time frame: Within 7 days after randomization.
Proportion of participants with headache
The proportion of participants with headache reported within 7 days after randomization;
Time frame: Within 7 days after randomization;
Proportion of participants with symptomatic intracranial hemorrhage
The proportion of participants with symptomatic intracranial hemorrhage reported within 7 days after randomization.
Time frame: Within 7 days after randomization.
All-Cause Mortality
Proportion of patients who died from any cause
Time frame: Within 90 days post-randomization
Proportion with symptomatic stroke (ischemic or hemorrhagic)
Time frame: Within 90 days post-randomization
Any Adverse Events (AEs)
Proportion experiencing any adverse events
Time frame: Within 90 days post-randomization
Plan to share: No
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Beijing Tiantan Hospital