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A Phase 2b Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke (MASTRE-2)

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 2b Trial: MASTRE-2

This Phase 2b 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 the efficacy and safety of this personalized brain stimulation approach and support planning for future confirmatory trials.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Acute ischemic stroke can lead to persistent motor impairment despite standard medical treatment and rehabilitation. The early post-stroke period may provide an important window for modulating brain network plasticity and supporting functional 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 enhance recovery when applied to clinically relevant motor networks.

This Phase 2b 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 brain 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 during treatment.

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 of participants and outcome assessors while isolating the effect of active stimulation.

The study is designed to evaluate the efficacy and safety of individualized lesion network mapping-guided cTBS for recovery after acute ischemic stroke and to inform the design of future confirmatory trials.

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
      • Beijing、中国、100070
        • Beijing Tiantan Hospital
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Zixiao Li, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：LNM-navigated cTBS group
Patients receive two daily sessions for 7 consecutive days. Each session uses a figure-8 coil under neuronavigation to deliver 3-pulse bursts at 50 Hz, repeated at 5 Hz (continuous theta burst) for a total of 600 pulses in 40 seconds per target. Targets are individualized via lesion network mapping of the patient's acute infarct, selecting symptom-relevant network nodes. Stimulus intensity is set at 80% of the resting motor threshold.
デバイス：LNM-navigated cTBS
Individualized treatment targets are defined by outlining lesion areas on each patient's MRI and projecting them onto a normative functional connectivity map to identify symptom-specific connectivity disruptions within sensorimotor regions. Twice-daily treatments, administered over seven consecutive days, employ an "8"-shaped coil guided by neuronavigation for real-time targeting. For each target, a 40-second session delivers 600 pulses at an intensity of 80% of each participant's resting motor threshold (RMT), administered as 3-pulse bursts at 50 Hz, repeated at a theta frequency of 5 Hz.
偽コンパレータ：Sham cTBS group
Procedures mimic the active group in coil positioning, timing, navigation, acoustic noise, and session schedule, but use a sham coil that produces no effective magnetic field.
デバイス：Sham cTBS
Sham LNM-navigated cTBS follows the identical workflow, including MRI-based lesion mapping, target selection, electric-field modeling, and neuronavigation, but uses a sham figure-8 coil that mimics the sound and sensation of stimulation without generating a significant magnetic field. Participants receive two sham treatment sessions per day for seven consecutive days. Each session follows the same 40-second protocol timing and coil positioning as the active intervention, ensuring that participants and assessors remain blinded while no effective pulses are delivered.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients achieving mRS 0-2
時間枠：Day 90 post-randomization
Day 90 post-randomization
Proportion experiencing serious adverse events (SAEs)
時間枠：Within 90 days post-randomization
Proportion experiencing serious adverse events (SAEs), including seizures
Within 90 days post-randomization

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients achieving mRS 0-1
時間枠：Day 90 post-randomization
Day 90 post-randomization
Early neurological deterioration
時間枠：7 days post-randomisation
Proportion of patients with neurological deterioration (defined as a ≥4-point increase in NIHSS score) within 7 days post-randomisation.
7 days post-randomisation
Proportion of participants with insomnia
時間枠：Within 7 days after randomization.
The proportion of participants with insomnia reported within 7 days after randomization.
Within 7 days after randomization.
Proportion of participants with headache
時間枠：Within 7 days after randomization;
The proportion of participants with headache reported within 7 days after randomization;
Within 7 days after randomization;
Proportion of participants with symptomatic intracranial hemorrhage
時間枠：Within 7 days after randomization.
The proportion of participants with symptomatic intracranial hemorrhage reported within 7 days after randomization.
Within 7 days after randomization.
All-Cause Mortality
時間枠：Within 90 days post-randomization
Proportion of patients who died from any cause
Within 90 days post-randomization
Proportion with symptomatic stroke (ischemic or hemorrhagic)
時間枠：Within 90 days post-randomization
Within 90 days post-randomization
Any Adverse Events (AEs)
時間枠：Within 90 days post-randomization
Proportion experiencing any adverse events
Within 90 days post-randomization
Distribution shift in modified Rankin Scale (mRS) score
時間枠：Day 90 post-randomization
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.
Day 90 post-randomization
Change from baseline in Fugl-Meyer Assessment of Motor Recovery after Stroke motor score at Day 7
時間枠：Day 7 post-randomization
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.
Day 7 post-randomization
Barthel Index for Activities of Daily Living score at Day 90
時間枠：Day 90 post-randomization
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.
Day 90 post-randomization
Proportion of Participants With Early Neurological Improvement at Day 7
時間枠：Day 7 post-randomization
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.
Day 7 post-randomization
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Index Score at Day 90
時間枠：Day 90 post-randomization
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.
Day 90 post-randomization

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Beijing Tiantan Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月26日

一次修了 (推定)

2027年9月30日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2026年6月9日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月16日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • KY2025-087

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