DementiaNCT05038579
Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence
A study testing Musiquence in people with Dementia, run by Universidade da Madeira at 1 site in Portugal.
Trial summary
Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life. This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Musiquence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2019to 28 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate stage of dementia (with formal diagnosis);
- Ability to move upper limbs;
- Maintained auditory acuity;
- Relatively preserved language skills.
Who cannot join
- Moderate to severe depressive symptomatology;
- Moderate to severe anxious symptomatology;
- Bedridden.
Trial locations and contacts
1 site in 1 country.
About this study
Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life.
This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence.
Read the detailed description
Dementia is a clinical syndrome characterized by a progressive and irreversible deterioration of cognitive functioning that impairs behavioral and functional domains. Within non-pharmacological approaches, Cognitive Stimulation Therapy (CST) is the most studied and well-established intervention for individuals with mild to moderate dementia. The underlying assumptions behind cognitive-based interventions of CST are:
- IwD can benefit from cognitive stimulation if mobilized relatively preserved cognitive functions (e.g., crystallized abilities such as semantic memory and verbal skills), and;
- Even in advanced age, exposure to enriched environments (i.e., socially and cognitively challenging) can enhance cognitive reserve and neuroplasticity.
Concerning the first assumption of cognitive-based interventions (a1), it is known that even in moderate to advanced stages of dementia, musical memory is one of the abilities that remain intact. It is hypothesized that music processing abilities precede the development of lexical language functions. This hypothesis is corroborated by findings that demonstrate that IwD are still responsive to music even when unable to communicate verbally or recognize words. Additionally, music is frequently associated with life experiences. Also, literature has reported that memories associated with specific music would be recollected longer than memories with no association to music; this suggests that using music as a reminiscence element on cognitive stimulation programs can have a promising effect on cognition. According to the second assumption of CST (a2), facilitating an enriching environment for IwD using, for , music and reminiscence elements could impact cognitive reserve and neuroplasticity.
In this context, Ferreira et al. developed a platform - Musiquence - that incorporates music and reminiscence in cognitive stimulation activities for IwD. Musiquence allows the gamification and personalization of 6 types of activities:
- Reality Orientation - a quiz-like activity that includes date and time information.
- Creative Drawings - a puzzle-like game in which the participant draws the missing pieces.
- Activities of Daily Living (ADL) - a puzzle-like game in which the participants have to perform a set of chores (i.e., brush the teeth), and the missing pieces are completed with real physical objects (i.e., toothpaste).
- Search Objects activity - exploration game in which the participants must find hidden images (e.g., cats) that are only visible through a virtual magnifying glass.
- Knowledge Quiz - participants must select the correct answer to a question among incorrect ones.
- Association activity - participants must categorize the items according to the instructions. For example, separate cars from motorcycles and locate them in the correct container.
The platform is compatible with different technologies that allow adaptation to the patients' needs (motor difficulties, vision problems, tremble). Cognitive stimulation content can be personalized to the user since the caregivers can add text, images, and music when creating the tasks.
- Conditions
- Dementia
- Being tested
- Musiquence
- Keywords
- Dementia, Cognitive stimulation, Musiquence, Music, Reminiscence, Augmented Reality
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusiquenceProcedure or surgery
The participants performed a customized cognitive stimulation program, that was implemented in an augmented reality format, using Musiquence.
| Study group | Role | What they receive |
|---|---|---|
| Musiquence | Experimental | Dementia group was involved in a 14-session customized cognitive stimulation program, using Musiquence. Receives: Procedure: Musiquence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (Cognitive Screening) (MMSE)
Change from baseline in the MMSE. Minimum of 0 points and maximum of 30 points. Higher scores mean better outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS - Cog)
Change from baseline in the ADAS-Cog. Minimum of 0 points and maximum of 68 points. Higher scores mean worse outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Secondary outcomes (8)
Quality of Life - Alzheimer's Disease (QoL - AD)
Change from baseline in the QoL - AD. Minimum of 0 points and maximum of 52 points. Higher scores mean better outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Kettler Laurent Thierreau (KLT)
Change from baseline in the KLT. Minimum of 0 points and maximum of 100 ponints.Higher scores mean worse outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)
Change from baseline in the SR Minimum of 0 points and maximum of 10 points.. Higher scores mean better outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)
Change from baseline in the DSC. Minimum of 0 points and maximum of 10 points. Higher scores mean better outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Semantic and Phonemic Verbal Fluency (SPVF)
Change from baseline in the SPVF. Minimum of 0 points and no maximum. Higher scores mean better outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Change from baseline in the IAFAI. Minimum of 0 points and maximum of 100 points. Higher scores mean worse outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Cornell Scale for Depression in Dementia
Change from baseline in the Cornell Scale for Depression in Dementia. Minimum of 0 points and maximum of 38 points. Higher scores mean worse outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Rating Anxiety in Dementia (RAID) scale.
Change from baseline in the RAID. Minimum of 0 points and maximum of 54 points. Higher scores mean worse outcomes.
Measured: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Sep 2019
- Primary completion30 Nov 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto São João de Deus, Casa de Saúde Câmara Pestana, Centro Social e Paroquial da Ribeira Brava, Associação de Desenvolvimento Comunitário do Funchal, Centro de Dia Lugar de Memórias
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038579
- Sponsor's protocol ID
- 9/CEUMA/2021
- Status last verified
- Sep 2021
- First submitted
- 4 May 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence
- ClinicalTrials.gov ID
- NCT05038579
- Acronym / sponsor ID
- 9/CEUMA/2021
- Conditions
- Dementia
- Keywords
- Dementia, Cognitive stimulation, Musiquence, Music, Reminiscence, Augmented Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Instituto São João de Deus, Casa de Saúde Câmara Pestana, Centro Social e Paroquial da Ribeira Brava, Associação de Desenvolvimento Comunitário do Funchal, Centro de Dia Lugar de Memórias
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- 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.
Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life.
This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence.
Detailed description
Dementia is a clinical syndrome characterized by a progressive and irreversible deterioration of cognitive functioning that impairs behavioral and functional domains. Within non-pharmacological approaches, Cognitive Stimulation Therapy (CST) is the most studied and well-established intervention for individuals with mild to moderate dementia. The underlying assumptions behind cognitive-based interventions of CST are:
- IwD can benefit from cognitive stimulation if mobilized relatively preserved cognitive functions (e.g., crystallized abilities such as semantic memory and verbal skills), and;
- Even in advanced age, exposure to enriched environments (i.e., socially and cognitively challenging) can enhance cognitive reserve and neuroplasticity.
Concerning the first assumption of cognitive-based interventions (a1), it is known that even in moderate to advanced stages of dementia, musical memory is one of the abilities that remain intact. It is hypothesized that music processing abilities precede the development of lexical language functions. This hypothesis is corroborated by findings that demonstrate that IwD are still responsive to music even when unable to communicate verbally or recognize words. Additionally, music is frequently associated with life experiences. Also, literature has reported that memories associated with specific music would be recollected longer than memories with no association to music; this suggests that using music as a reminiscence element on cognitive stimulation programs can have a promising effect on cognition. According to the second assumption of CST (a2), facilitating an enriching environment for IwD using, for , music and reminiscence elements could impact cognitive reserve and neuroplasticity.
In this context, Ferreira et al. developed a platform - Musiquence - that incorporates music and reminiscence in cognitive stimulation activities for IwD. Musiquence allows the gamification and personalization of 6 types of activities:
- Reality Orientation - a quiz-like activity that includes date and time information.
- Creative Drawings - a puzzle-like game in which the participant draws the missing pieces.
- Activities of Daily Living (ADL) - a puzzle-like game in which the participants have to perform a set of chores (i.e., brush the teeth), and the missing pieces are completed with real physical objects (i.e., toothpaste).
- Search Objects activity - exploration game in which the participants must find hidden images (e.g., cats) that are only visible through a virtual magnifying glass.
- Knowledge Quiz - participants must select the correct answer to a question among incorrect ones.
- Association activity - participants must categorize the items according to the instructions. For example, separate cars from motorcycles and locate them in the correct container.
The platform is compatible with different technologies that allow adaptation to the patients' needs (motor difficulties, vision problems, tremble). Cognitive stimulation content can be personalized to the user since the caregivers can add text, images, and music when creating the tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musiquence | Experimental | Procedure: MusiquenceDementia group was involved in a 14-session customized cognitive stimulation program, using Musiquence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate stage of dementia (with formal diagnosis);
- Ability to move upper limbs;
- Maintained auditory acuity;
- Relatively preserved language skills.
Key exclusion criteria (3 listed)
- Moderate to severe depressive symptomatology;
- Moderate to severe anxious symptomatology;
- Bedridden.
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 |
|---|---|---|
| MusiquenceThe participants performed a customized cognitive stimulation program, that was implemented in an augmented reality format, using Musiquence. | Procedure or surgery | Musiquence |
Primary outcome
Mini-Mental State Examination (Cognitive Screening) (MMSE)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Change from baseline in the MMSE. Minimum of 0 points and maximum of 30 points. Higher scores mean better outcomes.
Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS - Cog)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Change from baseline in the ADAS-Cog. Minimum of 0 points and maximum of 68 points. Higher scores mean worse outcomes.
8 secondary outcomes
Quality of Life - Alzheimer's Disease (QoL - AD)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Kettler Laurent Thierreau (KLT)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Semantic and Phonemic Verbal Fluency (SPVF)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Cornell Scale for Depression in Dementia
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Rating Anxiety in Dementia (RAID) scale.
Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musiquence in people with Dementia, run by Universidade da Madeira at 1 site in Portugal.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (Cognitive Screening) (MMSE) (time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.