DementiaNCT01958983
Music Therapy to Promote Emotion and Cognition for Dementia
A study testing Music Therapy Group Session in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Dementia
- What is being tested?
- Music Therapy Group Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Medical Foundation
Taoyuan, Taiwan, 333
Yu-Cheng Pei, PhD, 886-3-3281200 ext. 3846, yspeii@gmail.com
About this study
Official title: The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia
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).
Read the 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.
- Conditions
- Dementia
- Being tested
- Music Therapy Group Session
- Keywords
- dementia, drumming, emotion, cognition, functional MRI
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy Group SessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 8-week music therapy intervention
Secondary outcomes (5)
Change from Baseline on Geriatric Depression Scale (GDS) at 2 Months
Measured: Baseline and at 2 Months
Change from Baseline on Cohen-Mansfield Agitation Inventory (CMAI) at 2 Months
Measured: Baseline and at 2 Months
Change from Baseline on Inventory of Quality of Life (SF-36) at 2 Months
Measured: Baseline and at 2 Months
Change from Baseline on Frontal Assessment Battery (FAB) at 2 Months
Measured: Baseline and at 2 Months
Change from Baseline on Quality of Drum Improvisation at 2 Months
Measured: Baseline and at 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Cheng Pei, PhD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958983
- Sponsor's protocol ID
- 101-3041B
- Status last verified
- Sep 2013
- First submitted
- 6 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40049590
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Emotion and Cognition for Individuals With Mild to Moderate Dementia
- ClinicalTrials.gov ID
- NCT01958983
- Acronym / sponsor ID
- 101-3041B
- Conditions
- Dementia
- Keywords
- dementia, drumming, emotion, cognition, functional MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group Session | Experimental | Behavioral: Music Therapy Group SessionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a mild dementia diagnosis with Clinical Dementia Rating (CDR) score: 1 and The Mini Mental State Examination (MMSE) score: 18-24
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy Group Session | Behavioural | Music Therapy Group Session |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
- Derived from this study: PubMed 40049590van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Cheng Pei, PhD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy Group Session in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Cheng Pei, PhD (886-3-3281200 ext. 3846, yspeii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.