Music Therapy to Promote Emotion and Cognition for Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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).

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Music Therapy Group Session Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months [ Time Frame: Baseline and at 2 Months ]
  2. Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months [ Time Frame: Baseline and at 2 Months ]
  3. Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months [ Time Frame: Baseline and at 2 Months ]
  4. Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months [ Time Frame: Baseline and at 2 Months ]
  5. Change from Baseline on Quality of Drum Improvisation at 2 Months [ Time Frame: Baseline and at 2 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01958983

Contact: Yu-Cheng Pei, PhD 886-3-3281200 ext 3846
Contact: Yen-Hsuan Yang, PhD 773-888-1668

Chang Gung Medical Foundation Recruiting
Taoyuan, Taiwan, 333
Contact: Yu-Cheng Pei, PhD    886-3-3281200 ext 3846   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: Yu-Cheng Pei, PhD Chang Gung Medical Foundation

Responsible Party: Chang Gung Memorial Hospital Identifier: NCT01958983     History of Changes
Other Study ID Numbers: 101-3041B
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: September 2013

Keywords provided by Chang Gung Memorial Hospital:
functional MRI

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders