Study design
ASIA
SPINAL CORD
The DiSCIoser trial is designed as a randomized, controlled, assessors blinded single-centre trial with 2 parallel groups with 1:1 allocation ratio. The study flow is illustrated in Fig. DiSCIoser Randomized Controlled Trial summary. All Spinal Cord Injury (SCI) patients admitted to the Spinal Unit at Fondazione Santa Lucia IRCCS will be screened (T enrol) for eligibility according to Inclusion/Exclusion criteria. The evaluation according to the International Standards for Neurological Classification of SCI (ISNCSCI) ASIA Impairment Scale (AIS) and the predicted mean Upper Extremity Motor Score (UEMS) recovery will be used for eligibility. Eligible participants will be presented with the Informed Consent and recruited (30 participants). Clinical, neuropsychological, neurophysiological and neuroimaging assessments will be performed before (T pre) and after (T post) the interventionThe primary outcome is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score [
Standard protocol items as recommended for Interventional Trials (SPIRIT)The study is presented according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [