A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke

NCT07645586 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tiantan Hospital

Phase

Phase 3

Started

2026-10-01

Last updated

2026-08-18

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

LNM-navigated cTBSSham cTBS

LNM-navigated 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 cTBS: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age 18-80 years. 2. Ischemic stroke onset within the past 14 days. 3. Unilateral, supratentorial ischemic stroke confirmed by CT or MRI. 4. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 5. NIH Stroke Scale (NIHSS) total score 6-25, with item 1a ≤ 1 point, and at least one of items 5a, 5b, 6a, or 6b ≥ 2 points. 6. Written informed consent signed by the patient or the patient's legally authorized representative. Exclusion Criteria: 1. Contraindications to TMS (e.g. cranial metallic foreign bodies, cardiac pacemaker, implanted drug pump, cochlear implant). 2. History of epilepsy or seizure, intracranial hypertension, tumor, or other serious neurological disease. 3. Midline shift or parenchymal mass effect on cranial CT or other imaging. 4. CT or MRI evidence of bilateral acute cerebral infarction or infratentorial acute infarction (brainstem or cerebellum). 5. Evidence of acute intracranial hemorrhage, including spontaneous intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage. 6. Pre-stroke mRS ≥ 2. 7. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite antihypertensive treatment. 8. Pregnant or breastfeeding women, or women planning pregnancy within 90 days. 9. Severe psychiatric disorders or dementia (or other conditions) precluding informed consent or follow-up. 10. Concomitant malignant tumor or severe systemic disease with life expectancy \< 90 days. 11. Participation in any other interventional clinical study within 30 days before randomization, or currently enrolled in such a study.

Primary outcome measure(s)

Proportion of patients achieving mRS 0-2 — Day 90 post-randomization
Proportion experiencing serious adverse events (SAEs) — Within 90 days post-randomization
Proportion experiencing serious adverse events (SAEs), including seizures

Trial sites (1)

Facility	City	Region	Status
Beijing Tiantan Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07645586 on ClinicalTrials.gov ↗ ← All trials in China