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

NCT ID: NCT06429215

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Multi-component Intervention (MC-I)

VR cognitive training + Psychoeducation program

Group Type: EXPERIMENTAL

Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle

Intervention Type: DEVICE

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.

Cognitive-only intervention (CO-I)

VR Cognitive training + Psychoeducation active control

Group Type: ACTIVE_COMPARATOR

Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)

Intervention Type: DEVICE

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 control intervention (AC-I)

VR Cognitive active control + Psychoeducation active control

Group Type: ACTIVE_COMPARATOR

Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Maria Stefania De Simone

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

I.R.C.C.S Santa Lucia Foundation

Rome, Lazio, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Stefania De Simone, Dr

Role: CONTACT

ms.desimone@hsantalucia.it

(+39) 06-51501189

Facility Contacts

Maria Stefania De Simone, Dr

Role: primary

ms.desimone@hsantalucia.it

+39 0651501189

References

De Simone MS, Zabberoni S, Costa A, Tenaglia E, Tieri G. The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial. Front Psychol. 2025 Jul 11;16:1591239. doi: 10.3389/fpsyg.2025.1591239. eCollection 2025.

Reference Type: DERIVED

PMID: 40718565 (View on PubMed)

Other Identifiers

PRIN 2022 PNRR P2022E3CZY

Identifier Type: -

Identifier Source: org_study_id