Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory

NCT07584681 | Not Yet Recruiting

• 1 other identifier: 25-0754
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Connectomics

Outcome Measures

Primary Outcomes (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.

  1 year

Study Arms (1)

Primary Study Group

OTHER

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.

Other: MRI with connectomic sequencing

Interventions

MRI with connectomic sequencing OTHER

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

Primary Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Omniscient Neurotechnology: collaborator

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Related Publications (3)

• 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.

  PMID: 39077378 BACKGROUND

• 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.

  PMID: 34637901 BACKGROUND

• 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.

  PMID: 31082786 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Randy D'Amico, MD

  Northwell Health Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamika Wong, MPH

CONTACT

(212) 434-4836; twong4@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery, Department of Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)