Table 1 Trial Registration Data Set (according to WHO guidelines)

Primary registry and trial identifying number

ClinicalTrials.gov Identifier: NCT03674931

Date of registration in primary registry

17.09.2018

Secondary identifying numbers

Study ID number: 81185

Source(s) of monetary or material support

Swiss National Science Foundation (SNSF no. 100019E-170,410) and Deutsche Forschungsgemeinschaft (DFG no.323965454)

Primary sponsor

SNSF and DFG: Lead Agency grant (two-countries study)

Contact for public and scientific queries

Prof. Clara E. James: clara.james@hesge.ch

Title

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

Countries of recruitment

Switzerland, Germany

Health condition(s) or problem(s) studied

Age-related cognitive decline

Intervention(s)

Experimental group: intensive piano learning over 1 year

Active control group: musical culture learning over 1 year (history and listening)

Key inclusion and exclusion criteria

Ages eligible for study: 64 to 78 years Sexes eligible for study: both, Accepts healthy volunteers: only

Inclusion criteria: Healthy right-handed volunteers, between 64 and 78 years of age, native French/German 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 type

Interventional

Allocation: randomized intervention model according to 4 stratification factors (age, gender, score at the COGTEL (global cognition test) and socioeconomic status). Groups are balanced for those factors. Single blind study (subject)

Primary purpose: prevention of cognitive and sensorimotor decline in retired elderly

Date of first enrolment

May 2018

Target sample size

150

Recruitment status

Completed

Primary outcome(s)

Positive transfer effects from intensive piano training (intervention group) - as compared to listening and learning about music without practice (control group) - on age-related cognitive decline: for working memory, executive functions, speed of information processing, auditory selective attention (hearing in noise) and abstract thinking. Associated functional and structural brain plasticity may show in gray and white matter in temporal (medial and lateral), prefrontal and parietal areas. Less decline or increase of gray matter volume and activation change may show in the hippocampus, as well as improved functional networking in frontal areas during working memory tasks.

Key secondary outcomes

Benefits of fine perceptual-motor skills may also manifest in the intervention group as compared to the control group associated with functional and structural brain plasticity in sensorimotor areas. Subjective quality of life, verbal memory and hearing in noise may improve in both groups, the latter two associated with functional and structural brain plasticity in auditory and frontal areas. Epigenetic alterations may be induced by piano learning in relation with functional and structural imaging parameters.