Music Therapy to Promote Emotion and Cognition for Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01958983
• Other study ID #: 101-3041B
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2013
• Last updated: October 6, 2013
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: Chang Gung Memorial Hospital
• Contact: Yu-Cheng Pei, PhD
• Phone: 886-3-3281200
• Email: yspeii[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Music Therapy Group Session

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Foundation	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 8-week music therapy intervention	Yes
Secondary	Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months		Baseline and at 2 Months	No
Secondary	Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months		Baseline and at 2 Months	No
Secondary	Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months		Baseline and at 2 Months	No
Secondary	Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months		Baseline and at 2 Months	No
Secondary	Change from Baseline on Quality of Drum Improvisation at 2 Months		Baseline and at 2 Months	No