Cognitive Remediation, Mild Cognitive Impairment, Psychiatric Rehabilitation, Virtual Reality
Conditions
Brief summary
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)
Detailed description
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.
Interventions
DEVICEVirtual Reality Cognitive Remediation
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.
Sponsors
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 65 and above, a diagnosis of MCI based on DSM-IV criteria \[American Psychiatric Association, 2000\]
Exclusion criteria
* failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side effects; Dropout rates; Proportion of recruited participants among those considered eligible | T0 (0 weeks); T1 (12 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rey Figure Test | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on visual spatial function |
| Short Form Health Survey, 12 items (SF-12) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on quality of life, 12 items |
| Brief Social Rhythms Scale (BSRS) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on biological and social rhythms, 10 items |
| Patient Health Questionnaire (PHQ-9) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on depressive symptoms, 9 Items |
| Generalized Anxiety Disorder-7 item (GAD-7) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on anxiety, 7 items |
| Addenbrooke's Cognitive Examination (ACE-R) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia. |
| Cognitive Estimates Test (CET) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on executive function |
| Rey's Word Test | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on memory |
| Trail Making Test (TMT) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on executive function |
| Digit Span | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on memory |
| Stroop Test | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on executive function |
| Frontal Assessment Battery (FAB) | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on executive function |
| Matrix test | T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks) | Preliminary measures of effectiveness on attention |
Countries
Italy
Outcome results
None listed