The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia

The Hong Kong Polytechnic University1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2019年6月1日最近更新: 2020年10月22日

适应症

试验速览

阶段: 不适用
发起方: The Hong Kong Polytechnic University
入组人数: 80
试验地点: 1
主要终点: Haemodynamic changes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To study the effects of transcranial direct current stimulation on executive function in people with mild to moderate dementia

详细描述

Extensive research had shown executive dysfunction in people with dementia (PWD) is associated with functional abnormalities in prefrontal regions such as the right inferior frontal gyrus (Right IFG) or the left dorsal lateral pre-frontal cortex (Left DLPFC) . Clinical studies suggest that tDCS may be a useful therapeutic tool. Post-tDCS improvements have also been shown in visuo-motor coordination of healthy controls and performance in working memory. The aim of this study is to investigate the effect of tDCS stimulation over left DLPFC or right IFG on attention, inhibition and working memory and their neural correlates in people with dementia (PWD) and healthy controls (HC).This study is planned as a double-blinded, randomized case-control interventional study with a duration of 30 months.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double-blinded, with randomized case-control

入排标准

年龄范围: 65 Years 至 90 Years（Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•PWD must be aged at least 65 years or above when informed consent is obtained in the presence of his / her first degree relatives.
•PWD must meet criteria of DSM-V for dementia as well as for historical diagnosis of dementia.
•PWD must have a Chinese MoCA score > 19 (mild to moderate cognitive deficits) at screening.
•Subjects (both PWD and HC) must be physically healthy, and must be able to understand and be willing to sign the informed consent document

排除标准

•Subject with major neurological illness.
•Subject with other diagnosed psychiatric disorders
•Subjects reported with history of substance abuse, which including alcohol, drugs or any medication which is indicative of chronic abuse.
•Failures to comply with the study protocol or to follow the instructions.
•Self-reported with known skin diseases or skin allergy history.
•Self-reported with metallic implants, dentures
•Self-reported with history of claustrophobia. (This is excluded because subject needs to stay in a quiet room with the head-mounted fNIRS and tDCS, which may elicit their feeling of anxiety)