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Table 3 Documents: information & consent forms, agreements

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

TYPE OF DOCUMENT When What Action Who
Information on the study During presentations; via flyers;
“participant information form” (distributed or sent by post or mail)
Objectives of the study; Information on the inclusion/exclusion criteria; information on procedures and timelines; announcement of randomization within two different groups of music education; information on measurements and their frequency (n = 4): MRI, behavioral testing and blood sampling; information of reimbursing of travel expenses; telephone numbers and mails of the research team Answer questions during presentations or by mail or telephone and during first lab visit Research team
Declaration of informed consent After inclusion in the study (following the 2 pre-screening steps see Table 2) Consent to voluntary participate to the study with the right to withdraw at any time; accept the use of data for scientific and educational purposes, with assurance that the data will remain anonymous; to yes/no accept blood sampling (NOT an exclusion criterion); who to inform in case of potential unexpected detection of anomalies. Read & Sign Participant & member research team
Trust agreement Before the courses start The participant declares aiming to perform homework at least 30 min per day, 5 times per week, not to miss more than maximum 8 courses (on 40 in total), and announce absences and holidays well in advance with reasons and not to engage in any supplementary musical education Read & Sign Participant & member research team
MRI safety questionnaire Before MRI measurements Questions assuring MRI compatibility Read & Sign Participant & MRI operator
Debriefing on the fMRI task After MRI measurements Answer questions on sound perception, comprehension of the task, rating of difficulty of different experimental conditions, used strategies to perform the task, remarks Read, answer questions Participant & member research team
Homework questionnaire 3, 6, 9 & 12 months after the beginning of the music interventions Time per day and per week spent on homework on average Read and -sign Participant