Methods/design
hand movements
SECONDARY, BLIND
A total cohort of 30 participants will be enrolled and randomized in a single centre, single blind RCT to investigate the efficacy of BCI-MI training for hand movements, delivered during the subacute phase of SCI (hospitalization period). The primary and secondary outcome measures collected from participants assigned to BCI-MI training will be compared with those of participants who receive an equivalent dose of MI training without BCI support (Control-MI).All procedures conducted in this trial follow national institutional ethical standards and the Helsinki Declaration. The study protocol and related procedures were approved by the institutional review board: the Independent Ethical Committee of the Fondazione Santa Lucia (FSL), I.R.C.C.S., Rome, Italy (protocol CE/PROG.884 15-12-2020). The trial was registered on the clinicaltrials.gov in 05-12-2022 (trial registration number: NCT05637775).