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    【ChiCTR1900027311】Photo Neuro-Modulation Therapy to Adults
    
                    
                
    
                
    
                    
    
                        
    基本信息
    
                        
    
                            
    
                                
    
                                    
    登记号
    
                                    
    ChiCTR1900027311
    
                                
    
                                
    
                                    
    试验状态
    
                                    
    正在进行
    
                                
    
                            
    
                            
    
                                
    
                                    
    药物名称
    
                                    
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    药物类型
    
                                    
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    规范名称
    
                                    
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    首次公示信息日的期
    
                                    
    2019-11-08
    
                                
    
                            
    
                            
    
                                
    
                                    
    临床申请受理号
    
                                    
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    靶点
    
                                    
    
                                        
                                         
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    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
    
                                
    
                            
    
                        
    
                    
    
                    
    
                        
    申办单位信息
    
                        
    
                            
    
                                
    
                                    
    申请人联系人
    
                                    
    
                                        
                                    
    
                                
    
                                
    
                                    
    申请人名称
    
                                    
    
                                                                            
    
                                
    
                            
    
                            
    
                                
    
                                    
    联系人邮箱
    
                                    
    
                                                                            
    
                                
    
                                
    
                                    
    联系人邮编
    
                                    
    
                                
    
                            
    
                            
    
                                
    
                                    
    联系人通讯地址
    
                                    
    
                                                                            
    
                                
    
                            
    
                        
    
                    
    
                    
    
                        
    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
    
                                    
    
                                                                            
    
                                
    
                                
    
                                    
    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
    
                                    
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    目标入组人数
    
                                    
    40
    
                                
    
                            
    
                            
    
                                
    
                                    
    实际入组人数
    
                                    
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    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
    
                                    
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    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
    
                        
    
                            
    
                                
    
                                    
    研究负责人姓名
    
                                    
    
                                                                            
    
                                
    
                                
    
                                    
    试验机构
    
                                    
    香港中文大學威爾斯親王醫院心理學系
    
                                
    
                            
    
                            
    
                                
    
                                    
    研究负责人电话
    
                                    
    
                                                                            
    
                                
    
                                
    
                                    
    研究负责人邮箱
    
                                    
    
                                                                            
    
                                
    
                            
    
                            
    
                                
    
                                    
    研究负责人邮编
    
                                    
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    联系人通讯地址
    
                                    
    
                                                                            
    
                                
    
                            
    
                        
    
                    
    
                    
    
                
    
                                

                

                
    
                    
    
                        
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