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.
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.
United States1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI with connectomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted13 May 2026
- Study start19 May 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Omniscient Neurotechnology
- Responsible party
- Principal investigator, Randy D'Amico, Northwell Health
- Investigators
- Randy D'Amico, MD, Principal investigator, Northwell Health Lenox Hill Hospital
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 39077378Olafson 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 34637901Guggisberg 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectomic Alterations Following Acute Ischemic Stroke in the Middle Cerebral Artery Territory: A Pilot Study of Prognostic Value and Structural Disruption
- ClinicalTrials.gov ID
- NCT07584681
- Acronym / sponsor ID
- 25-0754
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Connectomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Omniscient Neurotechnology
- Study start
- 19 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Primary Study Group | Other | Other: MRI with connectomic sequencingArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI with connectomic sequencingResting-state functional MRI (rs-fMRI) and diffusion MRI (dMRI) sequences | Other | Primary Study Group |
Primary outcome
Feasibility of using Connectomic Sequencing in Stroke Patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 39077378Idesis 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.
- Background: PubMed 34637901Olafson 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.
- Background: PubMed 31082786Guggisberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randy D'Amico, MD principal investigator
Northwell Health Lenox Hill Hospital
1 site in 1 country: see every site and its status.
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.