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

16 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Fase 2

Contactos e Locais

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Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Comparador Falso: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of patients achieving mRS 0-2
Prazo: Day 90 post-randomization
Day 90 post-randomization
Proportion experiencing serious adverse events (SAEs)
Prazo: Within 90 days post-randomization
Proportion experiencing serious adverse events (SAEs), including seizures
Within 90 days post-randomization

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of patients achieving mRS 0-1
Prazo: Day 90 post-randomization
Day 90 post-randomization
Early neurological deterioration
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Within 90 days post-randomization
Within 90 days post-randomization
Any Adverse Events (AEs)
Prazo: Within 90 days post-randomization
Proportion experiencing any adverse events
Within 90 days post-randomization
Distribution shift in modified Rankin Scale (mRS) score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beijing Tiantan Hospital

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

26 de agosto de 2026

Conclusão Primária (Estimado)

30 de setembro de 2027

Conclusão do estudo (Estimado)

30 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

9 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KY2025-087

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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