Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms

NCT ID: NCT03494608

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2020-05-31

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.

Conditions

Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jun Wang

Chief nurse of Neurosurgery Department, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Wang, Master

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Central Contacts

Jun Wang, Master

Role: CONTACT

wangj229@126.com

(86)010-83198899 ext. 8639

Other Identifiers

UIACGF

Identifier Type: -

Identifier Source: org_study_id