Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory

7 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • New York
      • New York, New York, Stati Uniti, 10075
        • Lenox Hill Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of using Connectomic Sequencing in Stroke Patients
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Randy D'Amico, MD, Northwell Health Lenox Hill Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Ictus ischemico

Sottoscrivi