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

16 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Comparateur factice: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients achieving mRS 0-2
Délai: Day 90 post-randomization
Day 90 post-randomization
Proportion experiencing serious adverse events (SAEs)
Délai: Within 90 days post-randomization
Proportion experiencing serious adverse events (SAEs), including seizures
Within 90 days post-randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of patients achieving mRS 0-1
Délai: Day 90 post-randomization
Day 90 post-randomization
Early neurological deterioration
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: Within 90 days post-randomization
Within 90 days post-randomization
Any Adverse Events (AEs)
Délai: Within 90 days post-randomization
Proportion experiencing any adverse events
Within 90 days post-randomization
Distribution shift in modified Rankin Scale (mRS) score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing Tiantan Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

26 août 2026

Achèvement primaire (Estimé)

30 septembre 2027

Achèvement de l'étude (Estimé)

30 décembre 2027

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2025-087

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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