Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory

7 mai 2026 mis à jour par: Randy D'Amico, Northwell Health

Connectomic Alterations Following Acute Ischemic Stroke in the Middle Cerebral Artery Territory: A Pilot Study of Prognostic Value and Structural Disruption

This study seeks to use safe, powerful, non-invasive computing tools, including machine learning and advanced neuroimaging analysis, to better understand how stroke affects the brain's network of connections. Using structural MRI, including diffusion-weighted imaging, this study will generate a detailed map of brain pathways to evaluate how strokes in the middle cerebral artery (MCA) territory disrupt the brain's structural networks. In the future, this approach may help physicians better predict recovery, monitor neuroplasticity, and guide rehabilitation decisions after stroke.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

Stroke is one of the leading causes of long-term disability worldwide, with motor, cognitive, and functional impairments that often persist for months or years after the initial event. A central challenge in post-stroke care is the ability to predict individual recovery trajectories, which remain highly variable even among patients with similar clinical presentations. Traditional prognostic tools such as the National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) offer population-level trends but are limited in their capacity to reflect the nuanced, network-level impact of focal brain injury.

Recent advances in neuroimaging and network neuroscience have shown that stroke is not solely a focal disease, but one that disrupts distributed brain networks. Lesions often disrupt not only local cortical and subcortical areas but also distant, structurally and functionally connected regions. This phenomenon, known as diaschisis, contributes to impairments that cannot be explained solely by the visible infarct. In addition, secondary degeneration, and the reorganization of brain networks over time play a significant role in shaping recovery trajectories. These insights suggest that understanding how a stroke alters the brain's connectivity patterns could offer new avenues for more precise and individualized prognostication.

Functional recovery is driven by preserved region reorganization and compensatory network recruitment. Previous studies have demonstrated that areas with greater structural and functional disconnection were more likely to undergo functional reorganization over time. Furthermore, the extent of early post-stroke reorganization was significantly correlated with long-term motor recovery at six months. These findings underscore the potential of connectome-based biomarkers to serve as early indicators of recovery potential and targets for rehabilitation planning. Notably, studies have shown that these network-level features differ between stroke subtypes and are correlated with clinical severity and outcome, supporting their potential role as biomarkers of recovery.

Despite these promising findings, connectomic methods remain underutilized in clinical settings due to technical complexity and the absence of standardized tools for interpretation. However, clinical platforms such as Omniscient's Quicktome now offer automated and anatomically informed visualization of structural and functional brain networks derived from standard DWI and rs-fMRI data. While these tools have been applied primarily in neurosurgical planning, their use in stroke prognostication is an emerging area of research.

There is a growing need to bridge the gap between clinical neurology and network neuroscience by validating connectome-based tools in the context of acute stroke care. Integrating connectomics with standard clinical assessments may improve the accuracy of outcome prediction, guide patient-specific rehabilitation strategies, and support the development of individualized recovery profiles.

The study will: 1) create a prospective, observational dataset to evaluate MRI-derived structural and functional connectivity changes in patients with distal middle cerebral artery (MCA) strokes, including M1 and more distal occlusions who have received mechanical thrombectomy and/or intravenous thrombolytics; 2) include patients with residual motor deficits in the acute setting following reperfusion therapy, while excluding those with completed M1 infarcts; 3)assess the feasibility and validity of using connectome-based metrics (e.g., tract integrity and disruption patterns) to quantify white matter connectivity patterns; 4) correlate connectivity patterns with motor outcomes at 3 months using the key clinical assessments; NIHSS motor , Modified Rankin Scale (mRS), DRAGON scores, and THRIVE scores ; and 5) evaluate whether acute-phase connectomic profiles can predict long-term functional outcomes and contribute to the development of a "recovery potential" scale.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

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

Lieux d'étude

    • New York
      • New York, New York, États-Unis, 10075
        • Lenox Hill Hospital

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:

  • Age > 18 years;
  • Diagnosis of acute ischemic stroke with confirmed occlusion of the M1 or more distal MCA territory.
  • Received reperfusion therapy via mechanical thrombectomy or IV thrombolytics(Tenecteplase, or Alteplase).
  • Presence of a motor deficit on initial clinical exam (e.g., NIHSS > 0) and on immediate post-intervention exam.
  • Patients or health-care proxy must be able to provide informed consent.
  • Must be able to undergo sequential MRI at Lenox Hill Hospital, including resting-state fMRI (rs-fMRI) and diffusion MRI (dMRI) for, respectively, functional, and structural connectomic analyses.

Exclusion Criteria:

  • Age < 17 years;
  • Large vessel occlusions proximal to M1 (e.g., ICA), completed M1 occlusions.
  • Pre-stroke Modified Rankin Scale score ≥ 3
  • Known neurodegenerative disease or prior stroke affecting motor pathways.
  • Inability to undergo MRI due to cardiac pacemaker, claustrophobia, and metal implants that cannot be removed prior to MRI.
  • Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age require a pregnancy test at screening and agree to contraceptive practices during the study.
  • Poor image quality or incomplete imaging datasets.

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: Science basique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Primary Study Group
Arm participants will receive 3 resting-state functional MRIs (rs-fMRI) and diffusion MRIs (dMRI) prior to discharge and at 1- and 3-months post-intervention to generate functional and structural connectomes.
Resting-state functional MRI (rs-fMRI) and diffusion MRI (dMRI) sequences

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of using Connectomic Sequencing in Stroke Patients
Délai: 1 year
Structural and functional connectomics will be used as a metric to quantify white matter tract disruption in patients with acute ischemic stroke involving the M1 or more distal branches of the middle cerebral artery (MCA), who undergo mechanical thrombectomy and/or receive intravenous thrombolytics (Tenecteplase or Alteplase) and have persistent motor deficits after therapy. White matter tract disruption, connection density, and connection strength will be measured and quanitifed at baseline, 1 month, and 3 months. Clinical metrics (NIHSS, mRS, THRIVE, and DRAGON scores) will also be measured and correlated to the connectomic changes.
1 year

Collaborateurs et enquêteurs

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

Parrainer

Les enquêteurs

  • Chercheur principal: Randy D'Amico, MD, Northwell Health Lenox Hill 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.

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)

1 mai 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

7 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner