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临床试验/NCT01958983
NCT01958983Unknown不适用

The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Brain Changes from Baseline on Functional and Structural Connectivity at 2 Months by Multi-Model MRI Analyses

研究概览

简要总结

The purpose of this study is to determine if the effects of music therapy alter emotion and cognition performances of individuals with mild to moderate dementia. The music therapy intervention protocol is structured by drum improvisation, rhythm imitation, music cognition and song discussion. Attentive listening and active participation of the music training activities allow participants to utilize their focus of attention and comprehension of informational texts. Music therapy intervention is proposed to provide positive stimulations on emotion and cognitive functions of individuals with dementia. The results of the present study will clarify relationship between the effect of music therapy and the neural substrate of music therapy in anatomical and functional brain data obtained from MRI (fMRI).

详细描述

Individuals with dementia often exhibit deterioration in cognitive functions and experience changes in emotions and personalities. Due to the changes in the frontal and temporal lobes of the brain, individuals with dementia often experience an impaired ability to judge situations. Empirical studies have indicated that cognitive stimulation is essential to facilitate individuals with dementia in thinking, concentration, and memory. Structured music activities provide cognitive stimulation to individuals with dementia through attentive listening and active participation. Additionally, drum improvisation not only reflects the current status of an individual, but also serves as an audio feedback through free play.

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
None

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24

排除标准

  • significant visual and hearing impairment that hinders music listening and score reading
  • for fMRI safty: with shrapnel or other metal or electronic implants in their bodies

结局指标

主要结局

Brain Changes from Baseline on Functional and Structural Connectivity at 2 Months by Multi-Model MRI Analyses

时间窗: Baseline and after 8-week music therapy intervention

All participants will received two MRI scans at 0 and 2 months. Images will be acquired on a 3.0T Siemens MRI scanner with 12-channels head coil. All the images are acquired parallel to the anterior commissure-posterior commissure line. To minimize motion artifact generated during the image acquisition, each participant's head will be immobilized with cushions inside the coil. Three kinds of MRI techniques will be performed in this study, including T1-weighted high-resolution anatomical image, resting-state function MRI, and half-sphere diffusion spectrum imaging. Therefore, T1VBM(voxel-based morphology), TBSS(tract-based spatial statistics), functional brain network analysis, and structural brain network analysis will be employed for evaluating the changes of brain functional and structural connectivity in individuals with dementia in experimental and control groups.

次要结局

  • Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months(Baseline and at 2 Months)
  • Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months(Baseline and at 2 Months)
  • Change from Baseline on Quality of Drum Improvisation at 2 Months(Baseline and at 2 Months)
  • Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months(Baseline and at 2 Months)
  • Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months(Baseline and at 2 Months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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