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Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People (TBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674931
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
Swiss National Science Foundation
German Research Foundation
Information provided by (Responsible Party):
Clara E James, School of Health Sciences Geneva

Brief Summary:
This longitudinal study aims to countervail age-related cognitive and cerebral decline in healthy retired people through intensive piano / keyboard music practice in Switzerland and Germany.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Behavioral: musical practice Behavioral: music education Not Applicable

Detailed Description:
Recent data suggest that music making might prevent cognitive decline in the elderly. However, experimental evidence remains sparse and no information on the neurophysiological basis has been provided, although cognitive decline is a major impediment to healthy aging. This study combines for the first time protocolled music practice in elderly with cutting-edge neuroimaging. The investigators propose a multi-site Hannover-Geneva longitudinal randomized intervention study in altogether 100 retired healthy elderly (64-76) years, 70 Geneva, 100 Hannover), offering either piano instruction or instruction on musical culture for one year. Participants will be tested at 3 time points on cognitive, perceptual and motor abilities as well as via wide-ranging functional and structural neuroimaging data (Magnetic Resonance Imaging, MRI). The research team expects positive transfer effects from intensive piano training not only on subjective well-being, but also on executive functions, working memory, hearing in noise and relationships of these behavioral features with morphological and functional brain plasticity. This study may therefore for the first time be demonstrate, that music making can provoke important societal impacts by diminishing cognitive and perceptual-motor decline underpinned by functional and structural brain plasticity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Longitudinal RCT (clinical trial) with an experimental group and an active control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People in Germany and Switzerland
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: musical practice
Intensive weekly musical keyboard training over 12 months
Behavioral: musical practice
Intensive weekly musical keyboard training over 12 months

Active Comparator: music education
Recreative weekly musical courses without practice over 12 months
Behavioral: music education
Recreative weekly musical courses without practice over 12 months




Primary Outcome Measures :
  1. Continuous Echo-Planar Imaging (EPI) [ Time Frame: 18 months (4 measurements over time) ]
    Resting state functional Magnetic Resonance Imaging (MRI), informs on functional connectivity

  2. Magnetization-Prepared 2 Rapid Acquisition Gradient Echo (MP2RAGE) [ Time Frame: 18 months (4 measurements over time) ]
    Magnetic Resonance Imaging measure, allows to image gray matter

  3. functional Magnetic Resonance Imaging (fMRI) [ Time Frame: 18 months (4 measurements over time) ]
    Functional Imaging of a tonal Working Memory task, allows to study involved networks

  4. Magnetic Resonance Diffusion Tensor Imaging (MR-DTI) [ Time Frame: 18 months (4 measurements over time) ]
    Diffusion weighted echo-planar gradient echo sequence, allows to image white matter and structural connectivity

  5. Magnetic Resonance Arterial Spin Labeling (MR-ASL) [ Time Frame: 18 months (4 measurements over time) ]
    Blood perfusion assessment

  6. Behavioral Battery (cognitive function) [ Time Frame: 18 months (4 measurements over time) ]
    Comprehensive cognitive testing, full battery will be provided on request; involves Basic cognition, Executive Function, Fluid Intelligence, Verbal Memory


Secondary Outcome Measures :
  1. Behavioral Battery (sensorimotor function) [ Time Frame: 18 months (4 measurements over time) ]
    Sensorimotor testing, full battery will be provided on request; involves manual dexterity and hearing tests



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Ages Eligible for Study:   64 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy right-handed volunteers, between 64 and 76 years of age, native French speakers. No regular musical practice over the lifespan. Only retired individuals may participate.

Exclusion Criteria:

  • Impaired/not-corrected auditory or visual accuracy, neurological diseases in the present or the past, cardiovascular diseases, excessive hypertension, obesity, diabetes mellitus, beginning dementia, mild cognitive impairment, clinical depression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674931


Locations
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Switzerland
School of Health Sciences Geneva; HES-SO University of Applied Sciences and Arts Western Switzerland
Geneva, Switzerland, 1206
Sponsors and Collaborators
School of Health Sciences Geneva
Swiss National Science Foundation
German Research Foundation
Investigators
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Principal Investigator: Eckart Altenmüller, PhD Hochschule für Musik, Theater und Medien Hannover
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Responsible Party: Clara E James, Full Professor, School of Health Sciences Geneva
ClinicalTrials.gov Identifier: NCT03674931    
Other Study ID Numbers: 81185
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw (NIfTI format for MRI data) and preprocessed data will be made available to the scientific community, via an open source scientific data base.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: April 2022
Access Criteria: Scientific community only

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clara E James, School of Health Sciences Geneva:
countervail age-related cognitive and cerebral decline
healthy elderly
musical training
neuroimagery and brain plasticity
psychometrics
executive function
mental health
well-being
sensorimotor function
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders