Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms: a Multi-center Prospective Cohort Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 350
- Primary Endpoint
- the Incidence of cognitive dysfunction at 6 months after operation
- Last Updated
- 7 years ago
Overview
Brief Summary
This prospective single-center cohort study aims to identify the incidence of cognitive dysfunction after unruptured aneurysm operation and explore the influencing factors. The primary end point is the cognitive dysfunction at 6 months after operation.The features of cognitive function, mental status, neurological function recovery, and quality of life of patients with unruptured intracranial aneurysms at different time points would be analyzed.
Detailed Description
This main topics is to identify and screen the patients with unruptured aneurysm who likely to suffer from cognitive dysfunction. All examinations were administered by a trained neuropsychologist.The assessment of cognitive function and mental state would be performed before operation and 6 months after operation, with the use of Montreal Cognitive Assessment Scale (MoCA) for the cognitive function, the Hamilton Anxiety Scale (HAMA) and the Hamilton Depression Scale (HDMA) tests for the mental state. The Cognitive dysfunction at 6 months after operation would be the primary end point, and the underlying factors responsible for the declined cognitive function would be analyze. The assessment of neurological function and quality of life would be performed before operation,3 months after operation and 6 months after operation, with the use of the Modified Rankin Scale(mRS) and the Functional Activities Questionnaire(FAQ) for the neurological function, the Richards-Campbell Sleep Questionnaire(RCSQ) and the 36-item short from health survey(SF-36) tests for the quality of life.
Investigators
Jun Wang
Chief nurse of Neurosurgery Department, professor
Xuanwu Hospital, Beijing
Eligibility Criteria
Inclusion Criteria
- •At least one imaging (CTA / MRI / DSA) study to confirm unruptured intracranial aneurysms for the patients who would undergo surgical treatment for the first time.;
- •Patients who live independent with minimal care support, mRS score ≤3 points;
- •Age \> 14 years old;
- •Han ethnicity, Right handed, can complete the test;
- •Patient or family agrees to sign informed consent.
Exclusion Criteria
- •Other cerebrovascular diseases，such as ischemic stroke, arteriovenous malformation, etc;
- •With an unexplained subarachnoid hemorrhage;
- •History of Neurological disease surgery;
- •Previous psychiatric and dementia history that cannot communicate with other people;
- •Patients who refused to follow up.
Outcomes
Primary Outcomes
the Incidence of cognitive dysfunction at 6 months after operation
Time Frame: the 6th month after operation of the patient inclusion in the study
The Montreal Cognitive Assessment Scale (MoCA) scale contains 8 cognitive domain,11 items and is suitable for assess cognitive function which including: Attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation.. 1 point for each correct answer. No points if they make any errors. The total score is 30 points. For those who have been educated for 12 years or less and the total score of MoCA is less than 30, one point is added to the total MoCA score. According to the results of MoCA assessment, Patients were divided into two groups: cognitive dysfunction group and cognitive function normal group. MoCA score ≥26 points suggested normal cognitive function (CN).
Secondary Outcomes
- the difference in the percentage of patients with HDMA score ≥14 before operation and 6 months after operation(before operation and the 6th month after operation of the patient inclusion in the study)
- the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation(before operation and the 6th month after operation of the patient inclusion in the study)
- the tendency of SF-36 scores before operation, 3 months after operation, and 6 months after operation(before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study)
- the tendency of mRS scores and the difference in the percentage of patients with mRS scores 0-3 and 4-6 points before operation, 3 months after operation, and 6 months after operation(before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study)