NCT03674931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

July 6, 2018

Last Update Submit

May 10, 2022

Conditions

Age-related Cognitive Decline

Keywords

countervail age-related cognitive and cerebral declinehealthy elderlymusical trainingneuroimagery and brain plasticitypsychometricsexecutive functionmental healthwell-beingsensorimotor function

Outcome Measures

Primary Outcomes (6)

  • Continuous Echo-Planar Imaging (EPI)

    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)

    Magnetic Resonance Imaging measure, allows to image gray matter

    18 months (4 measurements over time)

  • functional Magnetic Resonance Imaging (fMRI)

    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)

    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)

    Blood perfusion assessment

    18 months (4 measurements over time)

  • Behavioral Battery (cognitive function)

    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 Outcomes (1)

  • Behavioral Battery (sensorimotor function)

    18 months (4 measurements over time)

Study Arms (2)

musical practice

EXPERIMENTAL

Intensive weekly musical keyboard training over 12 months

Behavioral: musical practice

music education

ACTIVE COMPARATOR

Recreative weekly musical courses without practice over 12 months

Behavioral: music education

Interventions

musical practiceBEHAVIORAL

Intensive weekly musical keyboard training over 12 months

musical practice
music educationBEHAVIORAL

Recreative weekly musical courses without practice over 12 months

music education

Eligibility Criteria

Age64 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Sciences Geneva; HES-SO University of Applied Sciences and Arts Western Switzerland

Geneva, 1206, Switzerland

Location

Related Publications (3)

  • Losch H, Altenmuller E, Marie D, Passarotto E, Kretschmer CR, Scholz DS, Kliegel M, Kruger THC, Sinke C, Junemann K, James CE, Worschech F. Acquisition of musical skills and abilities in older adults-results of 12 months of music training. BMC Geriatr. 2024 Dec 19;24(1):1018. doi: 10.1186/s12877-024-05600-2.

    PMID: 39702118DERIVED

  • Mack M, Marie D, Worschech F, Kruger THC, Sinke C, Altenmuller E, James CE, Kliegel M. Effects of a 1-year piano intervention on cognitive flexibility in older adults. Psychol Aging. 2025 Mar;40(2):218-235. doi: 10.1037/pag0000871. Epub 2024 Dec 16.

    PMID: 39679985DERIVED

  • 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.

    PMID: 33087078DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Eckart Altenmüller, PhD

    Hochschule für Musik, Theater und Medien Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Longitudinal RCT (clinical trial) with an experimental group and an active control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 6, 2018

First Posted

September 18, 2018

Study Start

April 1, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Raw (NIfTI format for MRI data) and preprocessed data will be made available to the scientific community, via an open source scientific data base.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
December 2022
Access Criteria
Scientific community only

Locations

CH(1)