Music Therapy to Promote Emotion and Cognition for Dementia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01958983
First received: October 6, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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).


Condition Intervention
Dementia
Behavioral: Music Therapy Group Session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and at 2 Months ] [ Designated as safety issue: No ]
  • Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months [ Time Frame: Baseline and at 2 Months ] [ Designated as safety issue: No ]
  • Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months [ Time Frame: Baseline and at 2 Months ] [ Designated as safety issue: No ]
  • Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months [ Time Frame: Baseline and at 2 Months ] [ Designated as safety issue: No ]
  • Change from Baseline on Quality of Drum Improvisation at 2 Months [ Time Frame: Baseline and at 2 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958983

Contacts
Contact: Yu-Cheng Pei, PhD 886-3-3281200 ext 3846 yspeii@gmail.com
Contact: Yen-Hsuan Yang, PhD 773-888-1668 yhyang1111@gmail.com

Locations
Taiwan
Chang Gung Medical Foundation Recruiting
Taoyuan, Taiwan, 333
Contact: Yu-Cheng Pei, PhD    886-3-3281200 ext 3846    yspeii@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Pei, PhD Chang Gung Medical Foundation
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01958983     History of Changes
Other Study ID Numbers: 101-3041B
Study First Received: October 6, 2013
Last Updated: October 6, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
dementia
drumming
emotion
cognition
functional MRI

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014