Istituto Auxologico Italiano
Milan, Lombardy, 20145, Italy
Location status: Recruiting
Location contact
Cosimo Tuena
CONTACT
NCT Number: NCT06079411
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Milan, Lombardy, 20145, Italy
Location status: Recruiting
Cosimo Tuena
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises
Time frame: 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)
A lower Corsi supra span score represents a lower visuospatial memory. The minimum score is 0.06 and the maximum is 29.16. Scores will be corrected for age and education and they depend on the score of the Corsi Block Tapping Test.
Time frame: 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)
A lower score in The Manikin test represents lower spatial rotation ability. The minimum score is 0, and the maximum score is equal to 30.
Time frame: 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)
A lower score in Mini Mental State Examination represents a worse symptom severity. The minimum score is 0, and the maximum score is equal to 30. Scores will be corrected for age and education.
Time frame: 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)
A lower score in the Babcock test represents a worse symptom severity. The minimum score is 0, and the maximum score is equal to 8 for the immediate score; The minimum score is 0, and the maximum score is equal to 8 for the delayed score. Scores will be corrected for age and education
Time frame: 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)
A lower score in the Corsi Block Tapping Test- Forward represents a worse symptom severity. The minimum score is 3, and the maximum score is equal to 9. Scores will be corrected for age and education.
Time frame: 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)
A lower score in the Corsi Block Tapping Test- Backward represents a worse symptom severity. The minimum score is 3, and the maximum score is equal to 8. Scores will be corrected for age and education.
Time frame: 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)
A higher score in the Trail Making Test represents a worse symptom severity. The minimum score is 0 and no time limit for the maximum score for Trail Making Test part A, Trail Making Test part B and Trail Making Test part BA scores.
Time frame: 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)
A lower score in the Clock Drawing Test represented a worse symptom severity. The minimum score is 0, and the maximum score is equal to 13.
Time frame: 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)
A lower score in the Money Roadmap test represented a worse symptom severity. The minimum score is 0, and the maximum score is equal to 32.
Time frame: 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)
A higher score in Subjective Spatial Navigation Complaints represented a worse symptom severity. The minimum score is 0, and the maximum score is 3.
Contact information is provided by the study sponsor or research team.
Istituto Auxologico Italiano
Other
Low-Cost Virtual Therapeutics and Digital Biomarkers for the Early Assessment and Personalized Treatment of Mild Cognitive Impairment
Acronym: VR-MCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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