NCT06079411

Virtual Therapeutics for MCI

Low-Cost Virtual Therapeutics and Digital Biomarkers for the Early Assessment and Personalized Treatment of Mild Cognitive Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Mild Cognitive Impairment (MCI) is a term used to describe the transitional stage that occurs between normal aging and the onset of dementia. Spatial disorientation is often considered a significant indicator for diagnosing dementia. Numerous studies have documented deficits in both the allocentric and egocentric spatial frames of reference, as well as difficulties in transitioning between them, in individuals with MCI. Rapid advances in computing technology have enabled researchers to conduct cognitive training and rehabilitation interventions with the assistance of technology. Therefore, the aim of the study is to use virtual therapeutics to train MCI spatial memory.

Detailed description

The current study aims to design, develop and test virtual therapeutics to train MCI spatial memory through virtual reality rehabilitation. 36 Participants will be randomly assigned to three different conditions: embodied low-end spatial VR training vs. the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) vs. a non-embodied low-end spatial VR training. The three conditions will consist of at least 8 sessions of 30/40 minutes 3 times a week. The study will measure changes in spatial memory, in particular in egocentric and allocentric memory. Each patient will be tested 3 times: 3 weeks before the pre-test (control waiting period), at the pre-test and after the intervention, namely post-test (3 time points).

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	virtual reality non-embodied	the non-embodied virtual reality spatial training will consist of egocentric and allocentric spatial memory training with passive navigation of 8 sessions of 30/40 minutes 3 times a week.
DEVICE	virtual reality embodied	the embodied virtual reality spatial training will consist of egocentric and allocentric spatial memory training with active navigation of 8 sessions of 30/40 minutes 3 times a week.
OTHER	treatment as usual	the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises

Timeline

• Start date: 2023-10-17
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2023-10-12
• Last updated: 2024-03-08

Locations

1 site across 1 country: Italy