Music Therapy to Promote Emotion and Cognition for Dementia
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|ClinicalTrials.gov Identifier: NCT01958983|
Recruitment Status : Unknown
Verified September 2013 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : October 9, 2013
Last Update Posted : October 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Music Therapy Group Session||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Music Therapy Group Session
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.
|Behavioral: Music Therapy Group Session|
No Intervention: No Music Therapy Session
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.
- Brain Changes from Baseline on Functional and Structural Connectivity at 2 Months by Multi-Model MRI Analyses [ Time Frame: 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.
- Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months [ Time Frame: Baseline and at 2 Months ]
- Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months [ Time Frame: Baseline and at 2 Months ]
- Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months [ Time Frame: Baseline and at 2 Months ]
- Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months [ Time Frame: Baseline and at 2 Months ]
- Change from Baseline on Quality of Drum Improvisation at 2 Months [ Time Frame: Baseline and at 2 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958983
|Contact: Yu-Cheng Pei, PhD||886-3-3281200 ext firstname.lastname@example.org|
|Contact: Yen-Hsuan Yang, PhDemail@example.com|
|Chang Gung Medical Foundation||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Yu-Cheng Pei, PhD 886-3-3281200 ext 3846 firstname.lastname@example.org|
|Principal Investigator:||Yu-Cheng Pei, PhD||Chang Gung Medical Foundation|