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

NCT03494608 | Unknown

• 1 other identifier: UIACGF
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Aneurysm

Keywords

cognitive function; quality of life; anxiety; depression; neurological function

Outcome Measures

Primary Outcomes (1)

• the Incidence of cognitive dysfunction at 6 months after operation

  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).

  the 6th month after operation of the patient inclusion in the study

Secondary Outcomes (4)

• 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 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 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

• 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

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients with unruptured intracranial aneurysms who treated in neurosurgery at Xuanwu Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• West China Hospital: collaborator
• Tang-Du Hospital: collaborator

MeSH Terms

Conditions

Intracranial Aneurysm; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jun Wang, Master

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Jun Wang, Master

CONTACT

(86)010-83198899; wangj229@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief nurse of Neurosurgery Department, professor

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: May 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 9, 2018

Record last verified: 2018-05