Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury
NCT Number: NCT06474871
Acronym: VR-sABI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acquired Brain Injury
Interventions: DEVICE: Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)|BEHAVIORAL: Traditional cognitive training (TCT)
Sponsor: Anna Estraneo
Collaborators: Istituti Clinici Scientifici Maugeri SpA|Ospedale Policlinico San Martino
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-30
Locations: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, Sant'Angelo Dei Lombardi, Avellino, 83054, Italy

Summary:
Considerable evidence exists for using Virtual Reality (VR) for rehabilitation of acquired brain injury (ABI), with a particular focus on stroke. However, to date very little evidence has been collected in patients with ABI with different aetiologies (i.e., traumatic or anoxic brain injury) and level of severity (i.e., severe, sABI). The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes, small sample sizes and a lack of randomized controlled trials, which can affect the level of evidence and generalizability of results, to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training (TCT).

Primary Outcome Measures: Trail Making Test (B-A score), The TMT is a neuropsychological test assessing executive functions. Higher scores indicate a better performance, 5 weeks
Secondary Outcome Measures: Trail Making Test (B-A score), The TMT is a neuropsychological test assessing executive functions. Higher scores indicate a better performance, 1 month after treatment|modified Barthel Index, It is a measure of functional disability, with higher scores indicating higher functional independence, 5 weeks - 1 month after treatment|Disability Rating Scale, It is a measure of functional disability, with higher scores indicating higher disability, 5 weeks - 1 month after treatment|System Usability Scale, It is a measure of usability and compliance. Higher scores indicate a better performance, 5 weeks - 1 month after treatment
Other Outcome Measures: NeuroPsychiatric Inventory, It is a measure of neurobehavioural and psychiatric disorders. Higher scores indicate a more severe disorder, 5 weeks - 1 month after treatment|Level of Cognitive Functioning, A clinical scale assessing global cognitive functioning. Higher scores indicate a higher cognitive functioning, 5 weeks - 1 month after treatment|Galveston Orientation and Amnesia Test, A clinical measure of post-traumatic amnesia. Higher scores indicate a more severe amnesia, 5 weeks - 1 month after treatment|Oxford Cognitive Screening, A screening neuropsychological test assessing different cognitive domains. Higher scores indicate a better cognitive performance, 5 weeks - 1 month after treatment|Spectral metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Microstate metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Connectivity metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Brain-derived neurotrophic factor, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment|Neurofilament-Light, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment|Glial fibrillary acidic protein, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment