Early Neurovascular Decoupling Trajectories After Revascularization in Acute Ischemic Stroke
ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multimodal Neuromonitoring
Diagnostic testA 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.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: AIS Revascularization Cohort1 intervention
Trial outcomes
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.
Time frame
From post-thrombectomy Day 1 to Day 7Secondary outcomes
1
90-day Functional Outcome
Functional status assessed using the modified Rankin Scale (mRS). The outcome will be analyzed both as an ordinal scale (0-6) and dichotomized into favorable outcome (mRS score 0-2) versus unfavorable outcome (mRS score 3-6).
Time frame
90 days (± 7 days) post-thrombectomy2
Early Neurological Deficit Change
Change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline (post-thrombectomy Days 1-3) and Day 7 post-thrombectomy.
Time frame
From baseline (Days 1-3) to Day 7 post-thrombectomy3
Neurovascular Decoupling Trajectory patterns as a Predictor of 90-day Outcome
Discriminative ability (measured by the Area Under the Receiver Operating Characteristic Curve, AUC) for predicting the dichotomized 90-day functional outcome (mRS 0-2 vs 3-6), using the neurovascular decoupling trajectory patterns derived from the primary outcome measure.
Time frame
At 90 days post-thrombectomy (using data from Days 1-7)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov