Early Neurovascular Decoupling Trajectories After Revascularization in Acute Ischemic Stroke

NCT07405762 | Not Yet Recruiting

• 2 other identifiers: 20262039XJLL-KY-20262039
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Recanalization therapy is the standard treatment for acute ischemic stroke (AIS), yet patient outcomes remain highly heterogeneous. The underlying mechanisms of this variability are not fully understood. Neurovascular coupling (NVC), the tight link between neural activity and cerebral blood flow, is fundamental for brain function. Its disruption (neurovascular decoupling) after stroke is hypothesized to be a key determinant of recovery, but its dynamic early trajectory and predictive value for long-term functional recovery are poorly characterized. Purpose: This observational study aims to delineate the early trajectory of neurovascular decoupling following endovascular thrombectomy in AIS patients and to investigate its association with long-term functional outcome. We seek to construct a single composite biomarker by integrating multimodal data, and to evaluate its predictive value for 90-day recovery. Methods: A prospective cohort of AIS patients who undergo successful endovascular thrombectomy will be enrolled. Multimodal monitoring will be performed at specific early time points: within Days 1-3 and at Day 7 post-procedure. Assessments include: Transcranial Doppler (TCD) for cerebral hemodynamics, Electroencephalography (EEG) for neural activity, and F-wave studies for spinal motoneuron excitability. Clinical severity will be assessed using the National Institutes of Health Stroke Scale (NIHSS) concurrently. The primary outcome is the early trajectory of a composite neurovascular decoupling index. The key predictive relationship between this trajectory and 90-day functional status (assessed using the modified Rankin Scale, mRS) will be evaluated. Significance: This study will provide novel insights into the early neurophysiological changes following successful thrombectomy. By defining the trajectory of neurovascular decoupling in the critical first week and linking it to long-term function, the findings may contribute to the development of early predictive models and guide personalized rehabilitation strategies.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Trajectory of Neurovascular Decoupling Index

  The longitudinal change (trajectory) of a composite neurovascular decoupling index from post-thrombectomy Day 1 to Day 7. The index is a single continuous variable calculated by integrating normalized scores from three key modalities: Transcranial Doppler (TCD) mean flow velocity (MFV) of the middle cerebral artery, Electroencephalography (EEG) power in the C3/C4 electrodes (over the sensorimotor cortex), and F-wave persistence. Distinct patterns will be derived from this index trajectory for subsequent analysis.

  From post-thrombectomy Day 1 to Day 7

Secondary Outcomes (3)

• 90-day Functional Outcome

  90 days (± 7 days) post-thrombectomy

• Early Neurological Deficit Change

  From baseline (Days 1-3) to Day 7 post-thrombectomy

• Neurovascular Decoupling Trajectory patterns as a Predictor of 90-day Outcome

  At 90 days post-thrombectomy (using data from Days 1-7)

Study Arms (1)

AIS Revascularization Cohort

Adult patients diagnosed with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion, who have undergone successful endovascular thrombectomy (achieving mTICI grade 2b or 3 reperfusion) within 24 hours of symptom onset.

Diagnostic Test: Multimodal Neuromonitoring

Interventions

Multimodal Neuromonitoring DIAGNOSTIC_TEST

A battery of assessments performed at Days 1-3 and Day 7 post-thrombectomy to evaluate neurovascular decoupling. This includes Transcranial Doppler (TCD) for cerebral hemodynamics, Electroencephalography (EEG) for neural activity, and F-wave studies for spinal motoneuron excitability.

AIS Revascularization Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (aged 18-85) with acute anterior circulation large vessel occlusion stroke, who have undergone successful endovascular thrombectomy within 24 hours of symptom onset, and are able to undergo early multimodal neuromonitoring.

You may qualify if:

• Age between 18 and 85 years
• Acute ischemic stroke due to occlusion of the anterior circulation large vessel (terminal internal carotid artery, or M1/M2 segment of the middle cerebral artery), confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
• Underwent endovascular thrombectomy with successful reperfusion, defined as a post-procedural modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2b or 3.
• Time from symptom onset to femoral artery puncture is ≤ 24 hours.
• Written informed consent is provided by the patient or their legally authorized representative.

You may not qualify if:

• Pre-stroke disability defined as a modified Rankin Scale (mRS) score ≥ 2.
• Severe impairment of consciousness within 24 hours post-thrombectomy, defined as a Glasgow Coma Scale (GCS) score ≤ 8.
• Inadequate temporal bone window preventing acquisition of stable blood flow signals by Transcranial Doppler (TCD).
• Conditions that may significantly compromise electroencephalography (EEG) quality, such as history of significant traumatic brain injury, skull defect, or intracranial metallic devices.
• Conditions that may invalidate F-wave studies, including peripheral neuropathy, cervical radiculopathy, or primary disease of the target muscles.
• Concurrent severe organ failure, malignancy, or a life expectancy of less than 3 months.
• Pregnancy or lactation.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Lang Jin

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lang Jin

CONTACT

+86-29-84773664; silencelang@163.com

Xiaona Li

CONTACT

+86-29-84773664; 598460221@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 12, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): September 5, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data and supporting documents will become available beginning 6 months after the publication of the primary results manuscript and will remain accessible for at least 5 years. Requests can be submitted during this period.
• Access Criteria: Access will be granted to researchers with a methodologically sound proposal for purposes of replicating analyses, conducting individual participant data meta-analysis, or addressing secondary research questions aligned with the original study objectives. Proposals should be submitted directly to the corresponding author (Dr. Lang Jin, silencelang@163.com) and will be reviewed by the study steering committee. Requestors will need to sign a data use/transfer agreement.