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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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 min
• Устройство 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.
• Устройство 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 minute

Первичные конечные точки

• Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Cognitive functioning (3): change scores on the Spatial pattern separation test [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]

Вторичные конечные точки (6)

• Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Intervention-induced changes in whole-brain functional connectivity [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]
• Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES) [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (around 6 weeks after baseline)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• I.R.C.C.S Santa Lucia Foundation — Rome

Публикации

• 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. PMID 40718565

Идентификаторы

NCT: NCT06429215 · PRIN 2022 PNRR P2022E3CZY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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