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Ischemic StrokeNCT07584681

Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory

A study testing MRI with connectomic sequencing in people with Ischemic Stroke, run by Northwell Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
MRI with connectomic sequencing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
19 May 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tamika Wong, MPH contact

(212) 434-4836

twong4@northwell.edu

United States1 site, 1 recruiting
  • Lenox Hill Hospital

    New York, New York, 10075

    Tamika Wong, MPH, (212) 434-4836, twong4@northwell.edu

    Sara Massimo, BS, (212) 434-4482, smassimo@northwell.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Ischemic Stroke
Being tested
MRI with connectomic sequencing
Keywords
Ischemic Stroke, Connectomics
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI with connectomic sequencingOther

    Resting-state functional MRI (rs-fMRI) and diffusion MRI (dMRI) sequences

Study groups in NCT07584681
Study groupRoleWhat they receive
Primary Study GroupOtherArm 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.
Receives: Other: MRI with connectomic sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of using Connectomic Sequencing in Stroke Patients

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start19 May 2026
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
The study does not involve a therapeutic intervention, such as diet, medication, vaccine, etc. It does require the acquisition of resting-state functional MRI (rs-fMRI) and diffusion MRI (dMRI) sequences prior to discharge and at 1- and 3-months, post-intervention to generate functional and structural connectomes and monitor changes over the course of recovery.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07584681
Sponsor's protocol ID
25-0754
Status last verified
Oct 2026
First submitted
29 Apr 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Idesis S, Allegra M, Vohryzek J, Perl YS, Metcalf NV, Griffis JC, Corbetta M, Shulman GL, Deco G. Generative whole-brain dynamics models from healthy subjects predict functional alterations in stroke at the level of individual patients. Brain Commun. 2024 Jul 13;6(4):fcae237. doi: 10.1093/braincomms/fcae237. eCollection 2024.

    PubMed 39077378
  • Olafson ER, Jamison KW, Sweeney EM, Liu H, Wang D, Bruss JE, Boes AD, Kuceyeski A. Functional connectome reorganization relates to post-stroke motor recovery and structural and functional disconnection. Neuroimage. 2021 Dec 15;245:118642. doi: 10.1016/j.neuroimage.2021.118642. Epub 2021 Oct 9.

    PubMed 34637901
  • Guggisberg AG, Koch PJ, Hummel FC, Buetefisch CM. Brain networks and their relevance for stroke rehabilitation. Clin Neurophysiol. 2019 Jul;130(7):1098-1124. doi: 10.1016/j.clinph.2019.04.004. Epub 2019 Apr 15.

    PubMed 31082786

Questions about this trial

What is this clinical trial studying?

A study testing MRI with connectomic sequencing in people with Ischemic Stroke, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tamika Wong, MPH ((212) 434-4836, twong4@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of using Connectomic Sequencing in Stroke Patients (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07584681, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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