A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke (MASTRE-3)
2026年8月16日 更新者：Zi-Xiao Li、Beijing Tiantan Hospital
Lesion Network Mapping-Navigated Continuous Theta-Burst Stimulation for Motor Recovery in Acute Ischemic Stroke: A Randomized, Double-Blind, Sham-Controlled, Multicentre Phase 3 Trial: MASTRE-3
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
584
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zixiao Li, MD
- 邮箱：lizixiao2008@hotmail.com
研究联系人备份
- 姓名：Lingling Ding, MD
- 电话号码：008613552358752
- 邮箱：dinglingling@bjtth.org
学习地点
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Beijing、中国、100070
- Beijing Tiantan Hospital
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接触：
- Zixiao Li, MD
- 邮箱：lizixiao2008@hotmail.com
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接触：
- Lingling Ding, MD
- 电话号码：008613552358752
- 邮箱：dinglingling@bjtth.org
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首席研究员：
- Zixiao Li, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
- 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.
- Written informed consent signed by the patient or the patient's legally authorized representative.
Exclusion Criteria:
- 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).
- Evidence of acute intracranial hemorrhage, including spontaneous intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
- Pre-stroke mRS ≥ 2.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite antihypertensive treatment.
- Pregnant or breastfeeding women, or women planning pregnancy within 90 days.
- Severe psychiatric disorders or dementia (or other conditions) precluding informed consent or follow-up.
- Concomitant malignant tumor or severe systemic disease with life expectancy < 90 days.
- Participation in any other interventional clinical study within 30 days before randomization, or currently enrolled in such a study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：LNM-navigated cTBS group
Participants receive active lesion network mapping (LNM)-navigated continuous theta burst stimulation (cTBS).
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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).
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假比较器：Sham cTBS group
Participants receive sham LNM-navigated cTBS using procedures that mimic the active intervention.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Proportion of patients achieving mRS 0-2
大体时间：Day 90 post-randomization
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Day 90 post-randomization
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Proportion experiencing serious adverse events (SAEs)
大体时间：Within 90 days post-randomization
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Proportion experiencing serious adverse events (SAEs), including seizures
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Within 90 days post-randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients achieving mRS 0-1
大体时间：Day 90 post-randomization
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Day 90 post-randomization
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Early neurological deterioration
大体时间：7 days post-randomisation
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Proportion of patients with neurological deterioration (defined as a ≥4-point increase in NIHSS score) within 7 days post-randomisation.
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7 days post-randomisation
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Proportion of participants with insomnia
大体时间：Within 7 days after randomization.
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The proportion of participants with insomnia reported within 7 days after randomization.
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Within 7 days after randomization.
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Proportion of participants with headache
大体时间：Within 7 days after randomization;
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The proportion of participants with headache reported within 7 days after randomization;
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Within 7 days after randomization;
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Proportion of participants with symptomatic intracranial hemorrhage
大体时间：Within 7 days after randomization.
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The proportion of participants with symptomatic intracranial hemorrhage reported within 7 days after randomization.
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Within 7 days after randomization.
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All-Cause Mortality
大体时间：Within 90 days post-randomization
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Proportion of patients who died from any cause
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Within 90 days post-randomization
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Proportion with symptomatic stroke (ischemic or hemorrhagic)
大体时间：Within 90 days post-randomization
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Within 90 days post-randomization
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Any Adverse Events (AEs)
大体时间：Within 90 days post-randomization
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Proportion experiencing any adverse events
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Within 90 days post-randomization
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Distribution shift in modified Rankin Scale (mRS) score
大体时间：Day 90 post-randomization
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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.
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Day 90 post-randomization
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Change from baseline in Fugl-Meyer Assessment of Motor Recovery after Stroke motor score at Day 7
大体时间：Day 7 post-randomization
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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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Day 7 post-randomization
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Barthel Index for Activities of Daily Living score at Day 90
大体时间：Day 90 post-randomization
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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.
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Day 90 post-randomization
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Proportion of Participants With Early Neurological Improvement at Day 7
大体时间：Day 7 post-randomization
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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.
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Day 7 post-randomization
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EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Index Score at Day 90
大体时间：Day 90 post-randomization
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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.
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Day 90 post-randomization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年9月30日
研究完成 (估计的)
2027年12月30日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年8月16日
最后验证
2026年8月1日
更多信息
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