Clinical trial NCT03494608: Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms
Official title: Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms: a Multi-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Keywords: cognitive function
quality of life
anxiety
depression
neurological function
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Tang-Du Hospital
First posted: 2018-04-11
Enrollment: 350
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital

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.

Eligibility criteria: Inclusion Criteria:

1. 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.;
2. Patients who live independent with minimal care support, mRS score ≤3 points;
3. Age \> 14 years old;
4. Han ethnicity, Right handed, can complete the test;
5. Patient or family agrees to sign informed consent.

Exclusion Criteria:

1. Other cerebrovascular diseases，such as ischemic stroke, arteriovenous malformation, etc;
2. With an unexplained subarachnoid hemorrhage;
3. History of Neurological disease surgery;
4. Previous psychiatric and dementia history that cannot communicate with other people;
5. Patients who refused to follow up.

Primary outcomes:
measure: the Incidence of cognitive dysfunction at 6 months after operation
timeFrame: the 6th month after operation of the patient inclusion in the study
Secondary outcomes:
measure: the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation
timeFrame: before operation and the 6th month after operation of the patient inclusion in the study
measure: the difference in the percentage of patients with HDMA score ≥14 before operation and 6 months after operation
timeFrame: before operation and the 6th month after operation of the patient inclusion in the study
measure: 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
timeFrame: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
measure: the tendency of SF-36 scores before operation, 3 months after operation, and 6 months after operation
timeFrame: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Jun Wang, Master
role: STUDY_CHAIR
References: