Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment; Cognitive Remediation; Virtual Reality; Psychiatric Rehabilitation

• Registration Number: NCT06270966
• Lead Sponsor: University of Cagliari

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Study Start: 2024-03-07
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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
Matrix test	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on attention
Trail Making Test (TMT)	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on executive function
Stroop Test	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on executive function
Rey Figure Test	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on visual spatial function
Frontal Assessment Battery (FAB)	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
Digit Span	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on memory
Cognitive Estimates Test (CET)	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)	Preliminary measures of effectiveness on executive function

Trial Locations

Locations (1)

San Giovanni di Dio Hospital; 🇮🇹 Cagliari, CA, Italy