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

From: 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

Data category Information32
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.