【ChiCTR1900027311】Photo Neuro-Modulation Therapy to Adults

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基本信息

登记号

ChiCTR1900027311

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2019-11-08

临床申请受理号

靶点

适应症

Mild Cognitive Impairment

试验通俗题目

Photo Neuro-Modulation Therapy to Adults

试验专业题目

Photo Neuro-Modulation Therapy to Middle Aged and Older Adults with Mild Memory Problem

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临床试验信息

试验目的

It is well-documented that mild cognitive impairment (MCI) is associated frontal lobe dysfunction and executive dysfunction. In addition, many studies reported high level of MCI symptoms among the elderly and the trend is increasing in Hong Kong. Based upon the link between MCI and frontal and executive function problems, it is conceivable that elderly who exhibits high levels of cognitive impairments would exhibit frontal and executive function problems. To our knowledge, there is still a lack of effective treatment or therapy for MCI, it is important to investigate effective intervention that can efficiently improve the cognitive ability of MCI patients. The objective of the present study is to compare individuals with MCI after the Photoneuromodulation Therapy (PNMT) and those who do not. A hundred and twenty middle aged and older adults were recruited from the subject database of the Neuropsychology Laboratory of The Chinese University of Hong Kong. Participants were divided randomly and equally into experimental group, as well as the control group. Several computerized executive function tests will be used before and after the treatment under the recording of near-infrared spectroscopy (NIRS) or Electroencephalography (EEG), which estimates level of frontal activation. The changes in hemodynamic response and brain waves will be recorded as well. It is hypothesized that compared to participants without PNMT, those with PNMT will have a better performance in the executive function tasks and exhibit a higher frontal activation as measured by the neuropsychological assessment. The cognitive and neurophysiological results would provide evidences on the possibility of PNMT in treating individuals with MCI, as well as with other mental disorders. In addition, PNMT may induce an addition, PNMT may induce an increase in frontal oxyhemoglobin, measured by NIRS, and increases in alpha and beta wave in EEG recordings, based on previous findings.

试验分类

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试验类型

随机抽样

试验分期

Ⅰ期

随机化

Randomized computer calculation

盲法

N/A

试验项目经费来源

n/a

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-02-03

试验终止时间

2020-07-31

是否属于一致性

入选标准

40 middle age and older adults with aged 40 or above who have subjective memory complaints；

排除标准

A history of head injury, or any neurological/psychiatric disorders, and dementia will be excluded. In addition, a score higher than 7 on the short form of the Chinese Geriatric Depression Scale (CGDS-SF; Lee, Chiu, Kwok, & Leung, 1993)；

研究者信息

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试验机构

香港中文大學威爾斯親王醫院心理學系

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