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OpenTrials
Completed

NCT Number: NCT05038579

Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade da Madeira

Funchal, Madeira, 9020-105, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Musiquence

Procedure

The participants performed a customized cognitive stimulation program, that was implemented in an augmented reality format, using Musiquence.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Quality of Life - Alzheimer's Disease (QoL - AD)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the QoL - AD. Minimum of 0 points and maximum of 52 points. Higher scores mean better outcomes.

  2. Kettler Laurent Thierreau (KLT)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the KLT. Minimum of 0 points and maximum of 100 ponints.Higher scores mean worse outcomes.

  3. Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the SR Minimum of 0 points and maximum of 10 points.. Higher scores mean better outcomes.

  4. Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the DSC. Minimum of 0 points and maximum of 10 points. Higher scores mean better outcomes.

  5. Semantic and Phonemic Verbal Fluency (SPVF)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the SPVF. Minimum of 0 points and no maximum. Higher scores mean better outcomes.

  6. Adults and Older Adults Functional Assessment Inventory (IAFAI)

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the IAFAI. Minimum of 0 points and maximum of 100 points. Higher scores mean worse outcomes.

  7. Cornell Scale for Depression in Dementia

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    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.

  8. Rating Anxiety in Dementia (RAID) scale.

    Time frame: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

    Change from baseline in the RAID. Minimum of 0 points and maximum of 54 points. Higher scores mean worse outcomes.

Sponsors and collaborators

Lead sponsor

Universidade da Madeira

Other

Collaborators

  • Associação de Desenvolvimento Comunitário do Funchal, Centro de Dia Lugar de Memórias
  • Casa de Saúde Câmara Pestana
  • Centro Social e Paroquial da Ribeira Brava
  • Instituto São João de Deus

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 9, 2021
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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