NCT01958983

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 9, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

October 6, 2013

Last Update Submit

October 6, 2013

Conditions

Keywords

dementiadrummingemotioncognitionfunctional MRI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months

    Baseline and at 2 Months

  • Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months

    Baseline and at 2 Months

  • Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months

    Baseline and at 2 Months

  • Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months

    Baseline and at 2 Months

  • Change from Baseline on Quality of Drum Improvisation at 2 Months

    Baseline and at 2 Months

Study Arms (2)

Music Therapy Group Session

EXPERIMENTAL

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 Music Therapy Session

NO INTERVENTION

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.

Interventions

Music Therapy Group Session

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Medical Foundation

Taoyuan District, Taiwan, 333, Taiwan

RECRUITING

Related Publications (1)

  • van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Yu-Cheng Pei, PhD

    Chang Gung Medical Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Cheng Pei, PhD

CONTACT

Yen-Hsuan Yang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 9, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 9, 2013

Record last verified: 2013-09

Locations