How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease?

April 18, 2024 updated by: David Franco Castellanos

Effect of Musical Intervention Based on Piano Learning on Alzheimer's Patients in León (España).

The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.

The key question is: Can pianistic practice influence the development of Alzheimer's disease?

Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease (AD) is a chronic neurodegenerative disease that affects different areas of the brain causing progressive changes in behavior, memory loss, decreased personal autonomy and various cognitive alterations. (Masters et al., NINDS, 2019; Alzheimer's Association, 2020)

According to the World Health Organization (WHO), currently around 50 million people suffer from some type of diagnosed dementia, of which 60-70% of them report some type or degree of EA. (Alzheimer's Association, 2020; WHO, 2020)

Not only is AD considered a worrying pathology today, but the forecast for medium and long term envisions a severe evolution that will reach 75 million cases in 2030 and 132 million in 2050. (Scheltens et al., 2016; MSCBS, 2019) Specifically in Spain there are more than 700,000 patients currently diagnosed and the forecast is that this number of people affected by AD will double in 2050. (MSCBS, 2019)

Since at the beginning of the s. XX the characteristics of AD were described for the first time (Mauer. K, 2006), scientific research has been, in its beginnings, aimed at alleviating the disease since a pharmacological point of view with modestly effective results (López, 2015) and effects secondary, sometimes unwanted. It therefore seems necessary to address the research and treatment of this disease from a non-pharmacological prism in which music has shown a high degree of efficiency with no adverse effects.

It is at this point that other alternative therapies such as music therapy take center stage. providing notable evidence of the brain activation that occurs, especially when the patient receives sound stimuli. (Peretz, 2005)

The value of music is evident in the numerous cases of musicians (pianists, violinists...) who after a diagnosis of AD begin to experience cognitive and physical deterioration expected, however, this degenerative process does not seem to affect their motor or intellectual to play his instrument even when the disease is in its most severe stage. (Pladdy, 2011)

Thus arises the need to go deeper and discover how music "interferes" in the process. neurodegenerative caused by AD and how it can partner with the patient to, potentially improve your quality of life, strengthen your cognitive reserve, become a useful routine and viable to implement active aging and, ultimately, accompany the patient during evolution of this pathology and, why not?, when the time comes to reverse its advance.

The most common interventions that focus on music as a vehicle to treat AD are aimed at mitigating stress, reducing anxiety and controlling agitation through listening, dancing or singing. (Baird, 2009) However, there are no studies that describe the influence that has to learn to play a musical instrument, in the case of this doctoral thesis: the piano, in the evolution of AD.

The piano is an instrument capable of mobilizing sight, hearing, touch, gross and fine motor skills, perception and emotion activating and making multiple parts of the brain interact (Paxinos, 2004) (hippocampus, cerebral cortex) which, judging by the latest studies, are related to the detection, evolution and treatment of AD.

Hypothesis:

- A therapy based on teaching patients with AD to play the piano may be beneficial for increase your Cognitive Reserve Capacity and improve your Quality of Life.

In this sense, it has been shown that complex mental activity throughout the life cycle can work as a neuroprotective factor in AD. (Valenzuela, 2006)

General objective:

- Analyze the effects of a musical intervention based on piano learning on Alzheimer's patients in León.

Specific objectives:

  • Generate a specific didactic program adapted to Alzheimer's patients based on in acquiring piano skills.
  • Involve the members under study in a prolonged musical experience in time (4 weeks) and value its significance from a therapeutic point of view.
  • Evaluate the evolution of the acquisition of sensory and musical skills in the course of the intervention.
  • Carry out a longitudinal-correlational study of the results obtained pre-post intervention. (Spss)
  • Make an evaluation of the didactic programming and the quality and suitability of the intervention at the end of it to, where appropriate, modify and reorient the aspects susceptible to improvement.

Methodology

The preparation of this study will be structured around three phases. A first phase of documentation on the state of the matter and preparation of the teaching materials that will form part of the resources necessary to carry out the therapeutic intervention. A second phase that will consist of the intervention itself, as well as the collection of the data provided by the control of the different variables subject to study, and finally, a third phase consisting of the evaluation of the data collected, as well as a critical assessment of the pedagogical procedure and, in If applicable, a proposal for an improvement plan for this intervention will be made.

The general methodology of the musical intervention will be an active, participatory, inclusive methodology and integrative, based on project-based learning. It will take into account at all times the uniqueness of each patient, therefore applying personalized attention. In it they will be used musical and extra-musical resources as formative elements, also valuing the Free improvisation as an artistic formula and musical and emotional expression.

The didactic programming will be aimed at developing motor control, developing the connection. Be careful, listen, and will also try to develop the capacity for self-criticism and frustration management, anxiety and emotional control.

The specific methodology of each therapy session will be defined in each of the units that they will make up the didactic programming prepared to carry out the intervention. Having in keep in mind that each session will last 30 minutes, the general methodological dynamic will revolve around this temporary organization:

Activation: 5´Making contact with himspace - teacher - instrument. Development: 20´ Pedagogical intervention. Relaxation: 5´Back to the calm.

Tests and variables:

Age, sex, socio-economic-cultural profile, nutritional status, motor status and other clinical data ofpatient interest. (tension, glucose...)

Cognitive state: (Minimal + (clock, cancellation and Ways))

  • Global
  • Domains: Memory (procedural and declarative. Language, Visuospatial.

Attention.

Visoconstructive, Executive abilities. Behavioral status: (medication) Typology of dementia (inclusion and exclusion criteria in the study) Degree of AD: (Mild moderate, severe, very severe) State of global deterioration.

Functional tests (RDRS-2 Rapid Disability Assessment Scale)

Cognitive evaluation tests: MOCA, WAIS-IV (digits), IST, ZAZZO, Trail Making Test, Clock, Fluency Verbal/categorical.

Neuropsychiatric evaluation test:

  • Behavioral disorders: BEHAVE-AD (Sclan 1996)
  • Frequency and severity of symptoms: Neuropsychiatric Inventory (NPI) (Cummings, 1994):
  • NPI-Q gravity part
  • NPI-Q caregiver stress
  • Evaluation of the severity of the disease (CDS and GDR Scales)
  • Evaluation of the caregiver's burden (Zarit test)

MEDIA AND MATERIAL RESOURCES AVAILABLE

This Initial Research Plan will be presented to the management of ALZHEIMER LEON to make a joint assessment of the suitability and viability of the proposed intervention.

Once approved its execution, the subjects who will make up the sample on which it will be determined will be determined. Will enhance the intervention. A series of tests will be carried out to determine the characteristics of the itself and inclusion/exclusion criteria will be set according to the needs of the study.

Additionally, there will be the departments of interest for the study (Psychology, psychiatry, therapists, social workers...) In addition, this intervention project will be presented to different entities to achieve maximum economic, human and institutional coverage. In this sense, some have been tested private and public institutions such as the Valverde de La Virgen School of Music through its City Council or JJMM-ULE, all of them showing great interest in the study and valuing positively their participation in the research without limiting for the moment the role that each of them they would take in the process.

To carry out the intervention it will be necessary to have a specialist pianist teacher, with a solid musical and pedagogical training and with an additional approach to the particularities of the sample and dynamics of the didactic programming prepared for the study. It will be very important and It is also necessary to have adequate financing to meet the expenses derived from the hiring and training of this professional and other unexpected expenses.

At all times we will try to find appropriate synergies with other entities interested in this study to join forces that give economic viability and dissemination to the project and its results through agreements, collaborations, donations or contributions of any nature.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Franco-Castellanos, Sr
  • Phone Number: 0034676099644
  • Email: dfrac@unileon.es

Study Contact Backup

Study Locations

  • Spain
    • Castilla Y León
      • León, Castilla Y León, Spain, 24004
        • Universidad de León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients in State of global deterioration Levels GDS 2 3 and 4.

Exclusion Criteria:

  • Other patients in GDS groups (not 2, 3 and 4)
  • The selected subject does not cooperate during intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grupo 0
Group on which the pianistic intervention will be carried out
Behavioral: Music therapy based on piano learning
The intervention will consist of pianistic training. Patients will receive piano classes adapted to their competence designed to achieve motor, sensory and behavioral control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State of global deterioration
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
GDS 1 - 7
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
Minimental Test
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
0-24
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
RDRS-2 Rapid Disability Assessment Scale
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
18-72
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
0-30
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
WAIS-IV
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
0-160
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
Behavioral disorders: BEHAVE-AD
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
NPI - CUMMINGS
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
0-120
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
Evaluation of the caregiver's burden (Zarit test)
Time Frame: Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.
0-88
Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Franco Castellanos

Collaborators

Jesús Ángel Seco Calvo
Javier Tejada Garcia

Investigators

  • Principal Investigator: David Franco-Castellanos, Sr, Universidad de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETICA-ULE-064-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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