Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People (TBM)
Primary Purpose
Age-related Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
musical practice
music education
Sponsored by

About this trial
This is an interventional prevention trial for Age-related Cognitive Decline focused on measuring countervail age-related cognitive and cerebral decline, healthy elderly, musical training, neuroimagery and brain plasticity, psychometrics, executive function, mental health, well-being, sensorimotor function
Eligibility 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.
Sites / Locations
- School of Health Sciences Geneva; HES-SO University of Applied Sciences and Arts Western Switzerland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
musical practice
music education
Arm Description
Intensive weekly musical keyboard training over 12 months
Recreative weekly musical courses without practice over 12 months
Outcomes
Primary Outcome Measures
Continuous Echo-Planar Imaging (EPI)
Resting state functional Magnetic Resonance Imaging (MRI), informs on functional connectivity
Magnetization-Prepared 2 Rapid Acquisition Gradient Echo (MP2RAGE)
Magnetic Resonance Imaging measure, allows to image gray matter
functional Magnetic Resonance Imaging (fMRI)
Functional Imaging of a tonal Working Memory task, allows to study involved networks
Magnetic Resonance Diffusion Tensor Imaging (MR-DTI)
Diffusion weighted echo-planar gradient echo sequence, allows to image white matter and structural connectivity
Magnetic Resonance Arterial Spin Labeling (MR-ASL)
Blood perfusion assessment
Behavioral Battery (cognitive function)
Comprehensive cognitive testing, full battery will be provided on request; involves Basic cognition, Executive Function, Fluid Intelligence, Verbal Memory
Secondary Outcome Measures
Behavioral Battery (sensorimotor function)
Sensorimotor testing, full battery will be provided on request; involves manual dexterity and hearing tests
Full Information
NCT ID
NCT03674931
First Posted
July 6, 2018
Last Updated
May 10, 2022
Sponsor
School of Health Sciences Geneva
Collaborators
Swiss National Science Foundation, German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03674931
Brief Title
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People
Acronym
TBM
Official Title
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People in Germany and Switzerland
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
School of Health Sciences Geneva
Collaborators
Swiss National Science Foundation, German Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
countervail age-related cognitive and cerebral decline, healthy elderly, musical training, neuroimagery and brain plasticity, psychometrics, executive function, mental health, well-being, sensorimotor function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Longitudinal RCT (clinical trial) with an experimental group and an active control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
musical practice
Arm Type
Experimental
Arm Description
Intensive weekly musical keyboard training over 12 months
Arm Title
music education
Arm Type
Active Comparator
Arm Description
Recreative weekly musical courses without practice over 12 months
Intervention Type
Behavioral
Intervention Name(s)
musical practice
Intervention Description
Intensive weekly musical keyboard training over 12 months
Intervention Type
Behavioral
Intervention Name(s)
music education
Intervention Description
Recreative weekly musical courses without practice over 12 months
Primary Outcome Measure Information:
Title
Continuous Echo-Planar Imaging (EPI)
Description
Resting state functional Magnetic Resonance Imaging (MRI), informs on functional connectivity
Time Frame
18 months (4 measurements over time)
Title
Magnetization-Prepared 2 Rapid Acquisition Gradient Echo (MP2RAGE)
Description
Magnetic Resonance Imaging measure, allows to image gray matter
Time Frame
18 months (4 measurements over time)
Title
functional Magnetic Resonance Imaging (fMRI)
Description
Functional Imaging of a tonal Working Memory task, allows to study involved networks
Time Frame
18 months (4 measurements over time)
Title
Magnetic Resonance Diffusion Tensor Imaging (MR-DTI)
Description
Diffusion weighted echo-planar gradient echo sequence, allows to image white matter and structural connectivity
Time Frame
18 months (4 measurements over time)
Title
Magnetic Resonance Arterial Spin Labeling (MR-ASL)
Description
Blood perfusion assessment
Time Frame
18 months (4 measurements over time)
Title
Behavioral Battery (cognitive function)
Description
Comprehensive cognitive testing, full battery will be provided on request; involves Basic cognition, Executive Function, Fluid Intelligence, Verbal Memory
Time Frame
18 months (4 measurements over time)
Secondary Outcome Measure Information:
Title
Behavioral Battery (sensorimotor function)
Description
Sensorimotor testing, full battery will be provided on request; involves manual dexterity and hearing tests
Time Frame
18 months (4 measurements over time)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
64 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eckart Altenmüller, PhD
Organizational Affiliation
Hochschule für Musik, Theater und Medien Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Sciences Geneva; HES-SO University of Applied Sciences and Arts Western Switzerland
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
December 2022
IPD Sharing Access Criteria
Scientific community only
Citations:
PubMed Identifier
33087078
Citation
James CE, Altenmuller E, Kliegel M, Kruger THC, Van De Ville D, Worschech F, Abdili L, Scholz DS, Junemann K, Hering A, Grouiller F, Sinke C, Marie D. Train the brain with music (TBM): brain plasticity and cognitive benefits induced by musical training in elderly people in Germany and Switzerland, a study protocol for an RCT comparing musical instrumental practice to sensitization to music. BMC Geriatr. 2020 Oct 21;20(1):418. doi: 10.1186/s12877-020-01761-y.
Results Reference
derived
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Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People
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