Data collection and management
CRF
CRF
An ad hoc CRF is implemented for all type and timing assessments.Specifically, the CRF will consist of two sections:i) the “Baseline and Randomization Section” which will contain each participant demographic, neurological and clinical data and all data collected for the screening section including the Informed Consent, the assigned randomized treatment, and the assessment before intervention (ii) the “Outcome and Training Section” which will not include data on assigned experimental treatment but will contain all the outcome collected in each training session and during the assessment after intervention (A specific standard operating procedure including time schedule, and instruction for management and compilation of the CRF will be used. All study staff responsible for outcome assessment (neurologists, neuropsychologists, neurophysiologists, therapists, neuroimaging researchers and other researchers involved) and training (therapists and EEG technicians) will be trained on procedures to ensure validity and reliability of trial data collection.