A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke (MASTRE-3)
2026년 8월 16일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
584
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zixiao Li, MD
- 이메일: lizixiao2008@hotmail.com
연구 연락처 백업
- 이름: Lingling Ding, MD
- 전화번호: 008613552358752
- 이메일: dinglingling@bjtth.org
연구 장소
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Beijing, 중국, 100070
- Beijing Tiantan Hospital
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연락하다:
- Zixiao Li, MD
- 이메일: lizixiao2008@hotmail.com
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연락하다:
- Lingling Ding, MD
- 전화번호: 008613552358752
- 이메일: dinglingling@bjtth.org
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수석 연구원:
- Zixiao Li, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of patients achieving mRS 0-2
기간: Day 90 post-randomization
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Day 90 post-randomization
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Proportion experiencing serious adverse events (SAEs)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of patients achieving mRS 0-1
기간: Day 90 post-randomization
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Day 90 post-randomization
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Early neurological deterioration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: Within 90 days post-randomization
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Within 90 days post-randomization
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Any Adverse Events (AEs)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2027년 9월 30일
연구 완료 (추정된)
2027년 12월 30일
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