Clinical trial NCT05038579: Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence
Official title: Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Cognitive stimulation
Musiquence
Music
Reminiscence
Augmented Reality
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
Collaborators: name: Instituto São João de Deus
name: Casa de Saúde Câmara Pestana
name: Centro Social e Paroquial da Ribeira Brava
name: Associação de Desenvolvimento Comunitário do Funchal, Centro de Dia Lugar de Memórias
First posted: 2021-09-09
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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:

1. IwD can benefit from cognitive stimulation if mobilized relatively preserved cognitive functions (e.g., crystallized abilities such as semantic memory and verbal skills), and;
2. 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.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate stage of dementia (with formal diagnosis);
* Ability to move upper limbs;
* Maintained auditory acuity;
* Relatively preserved language skills.

Exclusion Criteria:

* Moderate to severe depressive symptomatology;
* Moderate to severe anxious symptomatology;
* Bedridden.

Primary outcomes:
measure: Mini-Mental State Examination (Cognitive Screening) (MMSE)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS - Cog)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Secondary outcomes:
measure: Quality of Life - Alzheimer's Disease (QoL - AD)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Kettler Laurent Thierreau (KLT)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Semantic and Phonemic Verbal Fluency (SPVF)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Adults and Older Adults Functional Assessment Inventory (IAFAI)
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Cornell Scale for Depression in Dementia
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
measure: Rating Anxiety in Dementia (RAID) scale.
timeFrame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: Universidade da Madeira
state: Autonomous Region Of Madeira
Study officials:
References: