The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)
The European Union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI). Methods: A feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of MCI, randomly assigned to experimental condition or control group. Both groups will continue to receive standard pharmacological therapy (TAU). The experimental group will undergo a 3-months cognitive remediation program with fully immersive VR with two sessions per week (each session of sixty minutes). The control group will continue with TAU. Feasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. The preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Participants will undergo a 3-months cognitive remediation program using fully immersive VR with two sessions per week. Each session will last a maximum of sixty minutes and will be supervised by expert health professionals. The experimental group participated in an immersive VR-based CR program using the "CEREBRUM" software designed by clinicians and experts specializing in cognitive rehabilitation. CEREBRUM provides 52 exercises: Attention, Working Memory, Memory and Learning and Cognitive Estimates. The intervention included 24 sessions.
San Giovanni di Dio Hospital
Cagliari, CA, Italy
Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible and side effects.
Time frame: T0 (0 weeks); T1 (12 weeks)
Short Form Health Survey, 12 items (SF-12)
Preliminary measures of effectiveness on quality of life, 12 items
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Brief Social Rhythms Scale (BSRS)
Preliminary measures of effectiveness on biological and social rhythms, 10 items
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Patient Health Questionnaire (PHQ-9)
Preliminary measures of effectiveness on depressive symptoms, 9 Items
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Generalized Anxiety Disorder-7 item (GAD-7)
Preliminary measures of effectiveness on anxiety, 7 items
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Addenbrooke's Cognitive Examination (ACE-R)
Preliminary measures of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Matrix test
Preliminary measures of effectiveness on attention
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Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey's Word Test
Preliminary measures of effectiveness on memory
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Trail Making Test (TMT)
Preliminary measures of effectiveness on executive function
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Digit Span
Preliminary measures of effectiveness on memory
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Stroop Test
Preliminary measures of effectiveness on executive function
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Frontal Assessment Battery (FAB)
Preliminary measures of effectiveness on executive function
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Cognitive Estimates Test (CET)
Preliminary measures of effectiveness on executive function
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey Figure Test
Preliminary measures of effectiveness on visual spatial function
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)