Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT
NCT ID: NCT06270966
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-07
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Virtual Reality Cognitive Remediation + treatment as usual
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
Virtual 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.
Treatment as usual
The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care.
No interventions assigned to this group
Interventions
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Virtual 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.
Eligibility Criteria
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Inclusion Criteria
65 Years
ALL
No
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Mauro Giovanni Carta
Principal Investigator
Locations
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San Giovanni di Dio Hospital
Cagliari, CA, Italy
Countries
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Other Identifiers
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28287 08/11/2023
Identifier Type: -
Identifier Source: org_study_id
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