Virtual Therapeutics for MCI (VR-MCI)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Other: treatment as usual; Device: virtual reality embodied; Device: virtual reality non-embodied

Study type: Interventional

Funder types: Other

Identifiers

NCT06079411

39M202

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a change in cognition recognized by patients or observers (Caregiver/examiner)
• an objective impairment in one or more cognitive domains using traditional neuropsychological tests;
• autonomy or slight dependence on daily life activities;
• absence of diagnosis of dementia
• absence of cognitive impairment measured by the mini-mental state examination;
• aged 65 or over

Exclusion criteria

• the presence of acute stroke/transient ischemic attack occurred in the 6 months prior to the enrollment visit;
• the presence of aphasia and/or neglect;
• the presence of other concomitants severe neurological/psychiatric diseases (e.g., hemiparesis, multiple system atrophy, muscular skeletal/orthopedic deficits that limit movement)
• the presence of physical and/or functional deficits;
• the comorbidity with severe neurological and/or psychiatric diseases (e.g., neoplasms, multiple sclerosis, amyotrophic lateral sclerosis, Huntington's disease, schizophrenia, addiction, personality disorder, eating disorder) or with psychiatric conditions not under drug treatment (anxiety-depressive syndrome, bipolarism);
• the history of head trauma with loss of consciousness
• recurrent vertigo.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

TAU

Active Comparator group

Description:

the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises used in clinical routine of 8 sessions of 30/40 minutes 3 times a week.

Treatment:

Other: treatment as usual

VR non-embodied

Experimental group

Description:

the non-embodied 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.

Treatment:

Device: virtual reality non-embodied

VR embodied

Experimental group

Description:

the embodied 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.

Treatment:

Device: virtual reality embodied