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

NCT06270966 | Not Yet Recruiting

• 1 other identifier: 28287 08/11/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Mild Cognitive Impairment; Cognitive Remediation; Virtual Reality; Psychiatric Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  T0 (0 weeks); T1 (12 weeks)

Secondary Outcomes (13)

• Short Form Health Survey, 12 items (SF-12)

  T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

• Brief Social Rhythms Scale (BSRS)

  T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

• Patient Health Questionnaire (PHQ-9)

  T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

• Generalized Anxiety Disorder-7 item (GAD-7)

  T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

• Addenbrooke's Cognitive Examination (ACE-R)

  T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

Study Arms (2)

Virtual Reality Cognitive Remediation + treatment as usual

EXPERIMENTAL

15 Participants with more than 65 years and with MCI diagnosis will undergo a cognitive remediation program using fully immersive VR. Participants will continue with standard care during the experimental intervention

Device: Virtual Reality Cognitive Remediation

Treatment as usual

NO INTERVENTION

The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care.

Interventions

Virtual Reality Cognitive Remediation DEVICE

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.

Virtual Reality Cognitive Remediation + treatment as usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age 65 and above, a diagnosis of MCI based on DSM-IV criteria \[American Psychiatric Association, 2000\]

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

San Giovanni di Dio Hospital

Cagliari, CA, 09100, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: March 7, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

IT (1)