Structural and Clinical Predictors of Late Cognitive Impairment After Microsurgical Clipping of Ruptured Cerebral Aneurysms: A Retrospective Cohort With Prospective Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
This study investigates the clinical and structural predictors of long-term cognitive impairment in patients who underwent microsurgical clipping for aneurysmal subarachnoid hemorrhage. Using a retrospective cohort with prospective neuropsychological and MRI assessments, it aims to identify factors associated with late cognitive deficits and improve prognostic stratification, rehabilitation planning, and long-term patient care.
详细描述
Aneurysmal subarachnoid hemorrhage (aSAH) is associated with substantial morbidity, even among patients who remain functionally independent after treatment. Late cognitive deficits, particularly involving memory, attention, and executive function, are common in patients undergoing microsurgical clipping of ruptured cerebral aneurysms; however, the underlying mechanisms remain poorly understood. This study aims to identify clinical, acute radiological, and late structural predictors associated with cognitive impairment in these patients.
Participants will undergo a standardized late postoperative brain magnetic resonance imaging (MRI) evaluation (>1 year after treatment). Structural imaging variables to be analyzed as potential predictors of cognitive impairment include the presence or absence of hippocampal atrophy, frontal lobe atrophy, posterior cerebellar atrophy, pituitary gland atrophy, and deep gray nuclei atrophy, as well as quantitative measurements of white matter hyperintensity volume on FLAIR MRI, residual infarct volume, and cerebral perfusion. These imaging variables will be evaluated in combination with clinical and acute radiological characteristics to identify independent predictors of late cognitive impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of aSAH.
- •Treatment by microsurgical clipping of a ruptured cerebral aneurysm.
- •Survival until study recruitment.
- •Ability to understand and sign informed consent.
排除标准
- •Non-aneurysmal subarachnoid hemorrhage.
- •Exclusively endovascular treatment.
- •Previous diagnosis of dementia.
- •Severe neurological or psychiatric disorders unrelated to aSAH with significant cognitive impact.
- •Absolute contraindication to MRI.
- •Severe aphasia preventing adequate neuropsychological evaluation.
- •Incomplete clinical data.
- •Inability to attend in-person assessment.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA) score
时间窗: Through study completion, an average of 3 years
The MoCA is a global cognitive screening test with scores ranging from 0 to 30, where higher scores indicate better cognitive function. Cognitive impairment is defined as a MoCA score \<25, adjusted for educational level. A secondary analysis will also classify participants with MoCA \<23, adjusted for educational level, representing unfavorable functional outcome.
次要结局
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Through study completion, an average of 3 years)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 3 years)
- Modified Rankin Scale (mRS)(Through study completion, an average of 3 years)
- Return to work(Through study completion, an average of 3 years)
- In-hospital complications(Through study completion, an average of 3 years)
研究者
Thiago Magalhaes de Souza
Principal Investigator
University of Campinas, Brazil