Back to resultsMusic Therapy to Promote Emotion and Cognition for Dementia
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Music Therapy Group Session
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring dementia, drumming, emotion, cognition, functional MRI
Eligibility Criteria
Inclusion Criteria:
- a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24
Exclusion Criteria:
- 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
Sites / Locations
- Chang Gung Medical FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music Therapy Group Session
No Music Therapy Session
Arm Description
Participants will receive 60-minute group session twice a week over 2 months of period. Each session will be led by a music therapist. The contents of the music therapy session include drumming, rhythm imitation, score reading, lyrics comprehension, singing, and song discussion.
Participants will receive pre- and post-assessments and evaluations at 0 and 2 months. No intervention will be provided. Music therapy sessions will be offered to participants in completion of their study participation.
Outcomes
Primary Outcome Measures
Brain Changes from Baseline on Functional and Structural Connectivity at 2 Months by Multi-Model MRI Analyses
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.
Secondary Outcome Measures
Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months
Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months
Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months
Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months
Change from Baseline on Quality of Drum Improvisation at 2 Months
Full Information
NCT ID
NCT01958983
First Posted
October 6, 2013
Last Updated
October 6, 2013
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01958983
Brief Title
Music Therapy to Promote Emotion and Cognition for Dementia
Official Title
The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, drumming, emotion, cognition, functional MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy Group Session
Arm Type
Experimental
Arm Description
Participants will receive 60-minute group session twice a week over 2 months of period. Each session will be led by a music therapist. The contents of the music therapy session include drumming, rhythm imitation, score reading, lyrics comprehension, singing, and song discussion.
Arm Title
No Music Therapy Session
Arm Type
No Intervention
Arm Description
Participants will receive pre- and post-assessments and evaluations at 0 and 2 months. No intervention will be provided. Music therapy sessions will be offered to participants in completion of their study participation.
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy Group Session
Primary Outcome Measure Information:
Title
Brain Changes from Baseline on Functional and Structural Connectivity at 2 Months by Multi-Model MRI Analyses
Description
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.
Time Frame
Baseline and after 8-week music therapy intervention
Secondary Outcome Measure Information:
Title
Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months
Time Frame
Baseline and at 2 Months
Title
Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months
Time Frame
Baseline and at 2 Months
Title
Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months
Time Frame
Baseline and at 2 Months
Title
Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months
Time Frame
Baseline and at 2 Months
Title
Change from Baseline on Quality of Drum Improvisation at 2 Months
Time Frame
Baseline and at 2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Cheng Pei, PhD
Phone
886-3-3281200
Ext
3846
Email
yspeii@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Hsuan Yang, PhD
Phone
773-888-1668
Email
yhyang1111@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Cheng Pei, PhD
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Medical Foundation
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Cheng Pei, PhD
Phone
886-3-3281200
Ext
3846
Email
yspeii@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Music Therapy to Promote Emotion and Cognition for Dementia
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