Computerized Cognitive Training for MCI
A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
연구 개요
상세 설명
Introduction:
Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia, but are more pronounced than the cognitive decline associated with normal aging. The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these individuals seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Thus, MCI represents a critical window of opportunity for intervening and altering the trajectory of both cognitive decline and loss of functional independence in older adults. Cognitive function apart from memory such as executive function is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis on the training of executive function.
Objectives:
The objective of the study is to evaluate whether memory training combined with executive training could lead to improved cognitive and noncognitive performance in patients with MCI. Furthermore, we will explore the neural correlates underlying the changed performances.
Patients and Methods:
The proposed study is a single blinded, randomized and controlled trial that will include 120 elderly patients with MCI from the memory clinic. The groups will be randomized to either intervention or waiting-list group. The intervention is computerized combined memory and executive function training performed for 60 minutes x 4 times/week over 26 weeks. A neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after the intervention. The structural and functional MRI, EEG and NIRS will be performed at baseline and week 26 after intervention for a sub-study on the effect of cognitive training on brain structure and function.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100191
- 모병
- Peking University Institute of Mental Health(Six Hospital)
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연락하다:
- Haifeng Zhang, MS
- 전화번호: 86+18813185360
- 이메일: zhfphd@gmail.com
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연락하다:
- Xiaozhen Lv, PhD
- 전화번호: 86+82801983
- 이메일: lxz120300@163.com
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수석 연구원:
- Huali Wang, MD
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부수사관:
- Haifeng Zhang, MS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score < 26)
- Preserved general cognitive function( an mini-mental state examination (MMSE) score of > 24)
- Clinical Dementia Rating (CDR) = 0.5
- Hamilton Depression Scale (HAMD) score of < 12
- Intact activities of daily living (ADL score of <=26)
- Schooling education > = 5 years)
- Not meeting the diagnosis of dementia (according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Probable Alzheimer's Criteria
Exclusion Criteria:
- Serious visual or hearing impairment;
- Hachinski Ischemia Scale (HIS) >= 4;
- Subjects with Axis I disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), any other neurological disorders that could affect cognitive function;
- currently on titration of medications with cognitive enhancers or antidepressants;
- having any physical condition that could preclude regular attendance and full intervention-program participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Combined cognitive training
The training is combined executive function and memory training.
The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.
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Computerized combined executive function and memory training
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간섭 없음: Waiting-list group
Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period.
During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite working memory z score
기간: Change from baseline composite working memory z score at week 26
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composite score of digit span and spatial span
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Change from baseline composite working memory z score at week 26
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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cognitive test package (CTP)
기간: Changes from baseline composite CTP score at week 26
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composite score of episodic memory, speed processing, executive function, attention, language and social cognition
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Changes from baseline composite CTP score at week 26
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Self evaluated memory ability
기간: Change from baseline self evaluated memory ability at week 26
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Score on the questionnaire probes worries about memory (MMQ-contentment).
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Change from baseline self evaluated memory ability at week 26
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Brain Functional Imaging
기간: change from baseline functional connectivity at week 26
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Brain function measured with MRI.
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change from baseline functional connectivity at week 26
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Electrical activity of the brain
기간: change from baseline electrical brain activity at week 26
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Brain activity measured with electroencephalography (EEG).
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change from baseline electrical brain activity at week 26
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Brain structural imaging
기간: change from baseline cortical thickness at week 26
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cortical thickness measured with MRI
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change from baseline cortical thickness at week 26
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cerebral blood flow
기간: change from baseline cerebral blood flow at week 26
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Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
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change from baseline cerebral blood flow at week 26
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Mood
기간: Change from baseline composite mood score at week 26
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composite score of mood status
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Change from baseline composite mood score at week 26
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BDNF level
기간: change from baseline serum BDNF level at week 26
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Serum Brain-derived neurotrophic factor (BDNF) level
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change from baseline serum BDNF level at week 26
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Composite of overall cognition z scores
기간: Changes from baseline composite overall cognition z score at week 26
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Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
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Changes from baseline composite overall cognition z score at week 26
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공동 작업자 및 조사자
수사관
- 수석 연구원: Huali Wang, MD, Peking University Institute of Mental Health(Sixth hospital)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Combined executive function and memory training에 대한 임상 시험
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Queens College, The City University of New York완전한