Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia

ConditionDementia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorUniversity of Helsinki

About this trial

This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed dementia (according to International Classification of Diseases [ICD] criteria), which is mild [Clinical Dementia Rating (CDR) score: 0.5-1, Global Deterioration Scale (GDS) score: 3-4], moderate (CDR: 2, GDS: 4-6), or severe (CDR: 3, GDS: 6-7) dementia

Age ≥ 60 years

Finnish-speaking (or bilingual; the study is performed in Finnish)

Stable physical and somatic condition (no major changes in psychotropic medication during the last 3 months)

Disqualifiers

Prior severe psychiatric illness or substance abuse

Major hearing or visual impairment

Trial design

Design model

Parallel

Treatments tested in this trial

Conventional music therapy (CMT)
Behavioral
CMT comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and led by a professional music therapist. For PWDs living in a care home, the CMT sessions are implemented as inpatient rehabilitation held at the care home. For PWDs living at home, the CMT sessions are implemented as outpatient rehabilitation held at a local day activity centre.
Digital music rehabilitation (DMR)
Behavioral
DMR comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and implemented using a novel digital music content service called HILDA. In HILDA, there are a number of stand-alone musical programs hosted by a virtual presenter which the PWDs can follow and through which they can interact. The DMR sessions are moderated by an instructor (care home staff member or research assistant). For PWDs living in a care home, the DMR is implemented as live sessions held at the care home using a HILDA box connected to a TV screen and operated via a remote controller by the instructor. For PWDs living at home, the DMR is implemented as virtual sessions using a video communication platform that allows the instructor to stream and control the HILDA service and the participants to see and hear each other and interact.

Treatment groups

192 Participants

are divided into 3 treatment groups

Group A: Conventional music therapy (CMT)Experimental treatment 1 intervention

Group B: Digital music rehabilitation (DMR)Experimental treatment 1 intervention

Group C: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change from baseline in the MoCA score at 3-month stage

Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function

Time frame

Baseline and 3-month stage

Change from baseline in the CERAD total score at 3-month stage

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function

Time frame

Baseline and 3-month stage

Secondary outcomes

Change from baseline in the MoCA score at 6-month stage

Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function

Time frame

Baseline and 6-month stage

Change from baseline in the CERAD total score at 6-month stage

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function

Time frame

Baseline and 6-month stage

Change from baseline in the MoCA Fluency score at 3-month and 6-month stages

Montreal Cognitive Assessment (MoCA) Fluency subtest score (phonemic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills

Time frame

Baseline, 3-month stage and 6-month stage

Change from baseline in the CERAD Fluency score at 3-month and 6-month stages

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Fluency subtest score (semantic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills

Time frame

Baseline, 3-month stage and 6-month stage

Other outcomes

Association between baseline demographic and musical background factors and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

Demographic (e.g., age, gender, education) and musical (e.g., previous and current musical activity, music education) factors at baseline (data collected using interview / questionnaires). These data are used as predictors of treatment effects in the primary/secondary outcome measures.

Time frame

Baseline

Association between baseline music cognition indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

Different elements of music cognition (music perception, musical emotions, rhythmic timing, musical movement, singing) measured at baseline using questionnaires and short behavioural tasks. These data are used as predictors of treatment effects in the primary/secondary outcome measures.

Time frame

Baseline

Association between baseline ERP indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

Amplitude and latency of event-related potentials (ERPs) linked to auditory perception and memory in two passive auditory tasks measured at baseline using electroencephalography (EEG). These data are used as predictors of treatment effects in the primary/secondary outcome measures.

Time frame

Baseline

Association between baseline sMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

Grey matter volume in cortical and subcortical brain regions measured at baseline using structural magnetic resonance imaging (sMRI: MPRAGE sequence). These data are used as predictors of treatment effects in the primary/secondary outcome measures.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Helsinki

Lead sponsor

Helsinki University Central Hospital

Collaborator

City of Helsinki

Collaborator

Source ClinicalTrials.gov

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