REducing the Risk of COgnitive DEcline ad Dementia in Patients With Subjective Cognitive Decline Through an Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: the SCD-ReCODED Study (SCD-ReCODED)

May 20, 2024 updated by: Maria Stefania De Simone, I.R.C.C.S. Fondazione Santa Lucia

Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial

Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-perceived decline in cognition compared to five years ago
  • Lack of objective cognitive impairment.

Exclusion Criteria:

  • Clinically significant depression and anxiety;
  • Psychiatric disorders;
  • Unstable medical conditions.
  • Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
  • Dizziness or epilepsy history;

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-component Intervention (MC-I)
VR cognitive training + Psychoeducation program
Device: Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle

In a period of 5 consecutive weeks, participants will receive:

  • an interactive immersive virtual reality cognitive training for 30 minutes, 3 days per week. It consists in different tasks implemented in virtual real-like scenarios of daily living situations that target the following cognitive processes: long-term associative memory, relational binding, spatial pattern separation and pattern completion;
  • an interactive immersive virtual reality health and lifestyle education program for 30 minutes, 1 day per week. It consists in 360° videos aimed at advancing awareness and knowledge of the various health conditions associated with an increased risk of cognitive decline and dementia and helping participants to develop a healthier lifestyle.
Active Comparator: Cognitive-only intervention (CO-I)
VR Cognitive training + Psychoeducation active control
Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)

In a period of 5 consecutive weeks, participants will receive:

  • the interactive immersive virtual reality cognitive training as described in the MC-I condition, for about 30 minutes, 3 days per week;
  • an active control of the immersive virtual reality psychoeducation program for 30 minutes, 1 day per week.
Active Comparator: Active control intervention (AC-I)
VR Cognitive active control + Psychoeducation active control
Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control

In a period of 5 consecutive weeks, participants will receive:

  • an active control of the immersive virtual reality cognitive training (participants will be requested to virtually carry out daily actions, in the same setting as those performed in cognitive immersive VR training, but they will follow prearranged instructions requiring very low cognitive demands) for about 30 minutes, 3 days per week;
  • an active control of the immersive virtual reality psychoeducation program for about 30 minutes, 1 day per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
The Face-Name Associative Memory Exam (short form - FNAME12) is an associative long-term memory task that requires the participant to learn and retrieve 12 novel face-name and face-occupation pairs. It consists of two learning phases, followed by an immediate cued recall and a 30-min delayed recall and recognition trial.
Baseline, post-intervention (around 6 weeks after baseline)
Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
The Visual Short-Term Memory Binding Test is a recognition task based on a change detection paradigm for arrays of stimuli presented on a computer screen. Two conditions are investigated, that is, a shape-only condition as the first and a shape-color condition as the second. In both conditions, participants are asked to remember visual arrays of two or three black polygons (in the shape-only condition) or colored polygons (in the shape-color condition) presented for 2 s (study phase).
Baseline, post-intervention (around 6 weeks after baseline)
Cognitive functioning (3): change scores on the Spatial pattern separation test
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
The Spatial pattern separation test assesses the ability to differentiate partially overlapping patterns of activation in order to retrieve one pattern as separate from others that are similar. Specifically, it consists of 36 trials, in which the participant is required to learn the location of a grey circle on a sceen; then the participant is required to recognize the position of the previously-learned grey circle with respect to a foil located either to the left or the right of the target.
Baseline, post-intervention (around 6 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
The Subjective Memory Complaints Questionnaire assesses the subjective experience of memory decline. It consists of two sections. Part I provides a global evaluation of memory concerns responses to four general questions (4 items); Part II provides an evaluation of memory concerns in daily life (27 items). For each of the 31 items, participants are asked to respond on a 4-point Likert scale (1 = No, it does not happen to me; 2 = Sometimes, but it does not worry me; 3 = Yes and it worries me; 4 = Yes and it constitutes a problemin at least one area ofmy life, e.g., work, family, leisure, relationships). Higher scores are indicative of more serious memory complaints.
Baseline, post-intervention (around 6 weeks after baseline)
Intervention-induced changes in whole-brain functional connectivity
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
Connectomics changes after intervention will be investigated between pairs of regions of the whole brain (with particular interest in areas mainly involved in training-related cognitive processes) and in the global and local topological properties of large-scale networks through graph theoretical approach.
Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey
Time Frame: Baseline, post-intervention (around 6 weeks after baseline)
Baseline, post-intervention (around 6 weeks after baseline)

Collaborators and Investigators

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

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

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)

June 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIN 2022 PNRR P2022E3CZY

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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