Clinical trial NCT06270966: Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT
Official title: Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Remediation
Virtual Reality
Psychiatric Rehabilitation
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
timeFrame: T0 (0 weeks); T1 (12 weeks)
Secondary outcomes:
measure: Short Form Health Survey, 12 items (SF-12)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Brief Social Rhythms Scale (BSRS)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Generalized Anxiety Disorder-7 item (GAD-7)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Addenbrooke's Cognitive Examination (ACE-R)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Matrix test
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Rey's Word Test
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Trail Making Test (TMT)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Digit Span
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Stroop Test
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Frontal Assessment Battery (FAB)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Cognitive Estimates Test (CET)
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
measure: Rey Figure Test
timeFrame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: San Giovanni di Dio Hospital
state: CA
Study officials:
References: