- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674931
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People (TBM)
May 10, 2022 updated by: Clara E James, School of Health Sciences Geneva
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People in Germany and Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
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 Locations
-
-
-
Geneva, Switzerland, 1206
- School of Health Sciences Geneva; HES-SO University of Applied Sciences and Arts Western Switzerland
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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
64 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: musical practice
Intensive weekly musical keyboard training over 12 months
|
Intensive weekly musical keyboard training over 12 months
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Active Comparator: music education
Recreative weekly musical courses without practice over 12 months
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Recreative weekly musical courses without practice over 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous Echo-Planar Imaging (EPI)
Time Frame: 18 months (4 measurements over time)
|
Resting state functional Magnetic Resonance Imaging (MRI), informs on functional connectivity
|
18 months (4 measurements over time)
|
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
|
18 months (4 measurements over time)
|
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
|
18 months (4 measurements over time)
|
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
|
18 months (4 measurements over time)
|
Magnetic Resonance Arterial Spin Labeling (MR-ASL)
Time Frame: 18 months (4 measurements over time)
|
Blood perfusion assessment
|
18 months (4 measurements over time)
|
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
|
18 months (4 measurements over time)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 months (4 measurements over time)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eckart Altenmüller, PhD, Hochschule für Musik, Theater und Medien Hannover
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.
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 (Actual)
April 1, 2018
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
July 6, 2018
First Submitted That Met QC Criteria
September 14, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 10, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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