Clinical trial NCT06079411: Virtual Therapeutics for MCI
Official title: Low-Cost Virtual Therapeutics and Digital Biomarkers for the Early Assessment and Personalized Treatment of Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
name: University of Turin, Italy
First posted: 2023-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The long-term visuospatial memory scores from Corsi supra span
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: the spatial rotation score from the Manikin Test
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
Secondary outcomes:
measure: the cognitive global scores from Mini Mental State Examination
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: The verbal memory scores from the Babcock test
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: The short term visuospatial memory scores from the Corsi Block Tapping Test- Forward
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: the visuospatial working memory scores from the Corsi Block Tapping Test- Backward
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: The attention and executive functions score from the Trail Making Test
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: the visuospatial score from the Clock Drawing Test
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: the spatial rotation score from the Money Roadmap test
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
measure: Subjective Subjective Spatial Navigation Complaints sub-scale number 7
timeFrame: change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
state: Lombardia
Study officials:
References: