Mechanisms of Recovery Phenotypes: Early Neurovascular Decoupling Trajectories After Revascularization in Acute Ischemic Stroke Using Multimodal Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Trajectory of Neurovascular Decoupling Index
研究概览
简要总结
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.
详细描述
Study Title:Early Neurovascular Decoupling Trajectories after Revascularization in Acute Ischemic Stroke using Multimodal Monitoring（MAP-END）
- Background:
Despite successful revascularization with endovascular thrombectomy (EVT) for acute ischemic stroke (AIS), significant heterogeneity persists in patients' functional recovery. The underlying physiological mechanisms of this variability remain poorly understood, limiting accurate prognosis and the development of personalized rehabilitation strategies.
Neurovascular coupling (NVC), the precise physiological link between neural activity and regional cerebral blood flow, is fundamental for normal brain function. Post-stroke, factors such as ischemia-reperfusion injury and neuroinflammation may lead to NVC dysfunction, i.e., neurovascular decoupling. This decoupling is hypothesized to be a critical bridge connecting the primary ischemic insult to secondary neurological dysfunction and poor recovery.
Currently, the dynamic evolution of early neurovascular decoupling (particularly in the hyper-acute to sub-acute phases) following successful thrombectomy in AIS patients is not well characterized. Furthermore, whether such dynamic trajectories are systematically associated with distinct long-term functional recovery phenotypes lacks evidence from multimodal physiological monitoring. This study hypothesizes that quantifiable, heterogeneous trajectories of neurovascular decoupling exist in the early post-thrombectomy period and that these distinct trajectory patterns can predict patients' 90-day functional outcomes. 2. Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Time from symptom onset to femoral artery puncture is ≤ 24 hours.
- •Written informed consent is provided by the patient or their legally authorized representative.
排除标准
- •Pre-stroke disability defined as a modified Rankin Scale (mRS) score ≥
- •Severe impairment of consciousness within 24 hours post-thrombectomy, defined as a Glasgow Coma Scale (GCS) score ≤
- •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.
研究组 & 干预措施
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.
干预措施: Multimodal Neuromonitoring (Diagnostic Test)
结局指标
主要结局
Trajectory of Neurovascular Decoupling Index
时间窗: From post-thrombectomy Day 1 to Day 7
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.
次要结局
- 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))