A randomized controlled trial of combined executive function and memory training on the cognitive and noncognitive function of individuals with mild cognitive impairment: Study rationale and protocol design

一项关于执行功能和记忆力联合训练对轻度认知障碍患者认知和非认知功能影响的随机对照试验:研究原理和方案设计

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Abstract

INTRODUCTION: Cognitive training has attracted considerable attention as a safe, economical, and scalable nonpharmacologic intervention in patients with mild cognitive impairment (MCI). However, no study has yet placed sufficient emphasis on the training of executive function. The present study aimed 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. METHODS: The proposed study is a randomized controlled trial that will include 120 patients with MCI. The eligible patients will be randomized to either an intervention group or a waitlist control group. The intervention group will receive computerized combined training (executive function and memory) for 96 sessions for more than 24 weeks. The control group will receive no intervention during the research period. Behavior data collection and a magnetic resonance imaging/electroencephalogram/near-infrared spectroscopy scan will be performed at baseline and after 24 weeks of intervention. RESULTS: The study is currently ongoing. Recruitment began in July 2017 and will conclude in December 2018. DISCUSSION: If combined training results in positive changes to cognitive function and noncognitive function in patients with MCI, this might represent a new approach to delay the cognitive decline or even provide a potential method for dementia prevention. Furthermore, the evaluation of any training-related structural changes or functional changes will help to reveal the mechanisms underlying the combined cognitive training. TRIAL REGISTRATION: This study was registered with Clinicaltrials.gov (Identifier: NCT03232047, August 18, 2017).

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