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

2018년 5월 8일 업데이트: Jun Wang, Xuanwu Hospital, Beijing

Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms: a Multi-center Prospective Cohort Study

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.

연구 개요

상태

알려지지 않은

정황

두개내 동맥류

상세 설명

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.

연구 유형

관찰

등록 (예상)

350

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Jun Wang, Master
전화번호: 8639 (86)010-83198899
이메일: wangj229@126.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

14년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: 보병대
시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
the Incidence of cognitive dysfunction at 6 months after operation 기간: 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).	the 6th month after operation of the patient inclusion in the study

2차 결과 측정

결과 측정	측정값 설명	기간
the difference in the percentage of patients with HAMA score ≥14 before operation and 6 months after operation 기간: before operation and the 6th month after operation of the patient inclusion in the study	The Hamilton Anxiety Scale (HAMA) scale contains 14 items and is suitable for the adults with anxiety. Each item is divided into 5 grades evaluated using 0 to 4 scores. The total scores of HAMA scale can reflect patients' anxious condition to some extent. The total scores of less than 7 is regarded as no anxiety, 7 or more possible anxiety, 14 or more definite anxiety, 21 or more marked anxiety, 29 or more severe anxiety. In this study, Anxiety is defined as≥14 points.	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 기간: before operation and the 6th month after operation of the patient inclusion in the study	The Hamilton Depression Scale (HAMD) scale contains 24 items and is suitable for the adults with depression. Each item is divided into 5 grades evaluated using 0 to 4 scores. The total scores of the HAMD scale can reflect patients' depressive condition to some extent. The total scores of less than 8 is regarded as no depression, 8 to 16 mild depression, 17 to 24 moderate depression, and more than 24 severe depression. In this study, Depression is defined as≥14 points.	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 기간: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study	The Modified Rankin Scale (mRS) is a valid and clinically relevant instrument that is used to assess recovery (death, disability, and dependence) after stroke and is a commonly used outcome measure in SAH studies. The mRS ranges from 0 (no symptoms) to 6 (death). Unfavourable outcome in survivors is defined as mRS 3-5.	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 기간: before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study	36-item short form health survey(SF-36)	before operation ,the 3th month and the 6th month after operation of the patient inclusion in the study

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Xuanwu Hospital, Beijing

협력자

West China Hospital

Tang-Du Hospital

수사관

연구 의자: Jun Wang, Master, Xuanwu Hospital, Beijing

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2018년 5월 1일

기본 완료 (예상)

2020년 2월 1일

연구 완료 (예상)

2020년 5월 1일

연구 등록 날짜

최초 제출

2018년 4월 3일

QC 기준을 충족하는 최초 제출

2018년 4월 3일

처음 게시됨 (실제)

2018년 4월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 5월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 5월 8일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

UIACGF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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