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

February 13, 2024 updated by: Mauro Giovanni Carta, University of Cagliari

Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CA
      • Cagliari, CA, Italy, 09100
        • San Giovanni di Dio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
No Intervention: Treatment as usual
The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
Time Frame: 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.
T0 (0 weeks); T1 (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form Health Survey, 12 items (SF-12)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on quality of life, 12 items
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Brief Social Rhythms Scale (BSRS)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on biological and social rhythms, 10 items
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Patient Health Questionnaire (PHQ-9)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on depressive symptoms, 9 Items
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Generalized Anxiety Disorder-7 item (GAD-7)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on anxiety, 7 items
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Addenbrooke's Cognitive Examination (ACE-R)
Time Frame: 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.
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Matrix test
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on attention
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey's Word Test
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on memory
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Trail Making Test (TMT)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on executive function
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Digit Span
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on memory
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Stroop Test
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on executive function
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Frontal Assessment Battery (FAB)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on executive function
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Cognitive Estimates Test (CET)
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on executive function
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey Figure Test
Time Frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Preliminary measures of effectiveness on visual spatial function
T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 7, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28287 08/11/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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