A Phase 2b Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke (MASTRE-2)
16 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zixiao Li, MD
- Correo electrónico: lizixiao2008@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Lingling Ding, MD
- Número de teléfono: 008613552358752
- Correo electrónico: dinglingling@bjtth.org
Ubicaciones de estudio
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Beijing, Porcelana, 100070
- Beijing Tiantan Hospital
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Contacto:
- Zixiao Li, MD
- Correo electrónico: lizixiao2008@hotmail.com
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Contacto:
- Lingling Ding, MD
- Número de teléfono: 008613552358752
- Correo electrónico: dinglingling@bjtth.org
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Investigador principal:
- Zixiao Li, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of patients achieving mRS 0-2
Periodo de tiempo: Day 90 post-randomization
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Day 90 post-randomization
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Proportion experiencing serious adverse events (SAEs)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of patients achieving mRS 0-1
Periodo de tiempo: Day 90 post-randomization
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Day 90 post-randomization
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Early neurological deterioration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Within 90 days post-randomization
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Within 90 days post-randomization
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Any Adverse Events (AEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
26 de agosto de 2026
Finalización primaria (Estimado)
30 de septiembre de 2027
Finalización del estudio (Estimado)
30 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2025-087
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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