VR-MCI: Virtual Therapeutics for MCI
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TAU 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. |
Other: treatment as usual
the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises
|
| Experimental: VR non-embodied 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. |
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.
|
| Experimental: VR embodied 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- The long-term visuospatial memory scores from Corsi supra span [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.
- the spatial rotation score from the Manikin Test [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.
Secondary Outcome Measures
- the cognitive global scores from Mini Mental State Examination [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.
- The verbal memory scores from the Babcock test [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
- The short term visuospatial memory scores from the Corsi Block Tapping Test- Forward [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.
- the visuospatial working memory scores from the Corsi Block Tapping Test- Backward [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.
- The attention and executive functions score from the Trail Making Test [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.
- the visuospatial score from the Clock Drawing Test [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.
- the spatial rotation score from the Money Roadmap test [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.
- Subjective Subjective Spatial Navigation Complaints sub-scale number 7 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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a change in cognition recognized by patients or observers (Caregiver/examiner)
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an objective impairment in one or more cognitive domains using traditional neuropsychological tests;
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autonomy or slight dependence on daily life activities;
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absence of diagnosis of dementia
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absence of cognitive impairment measured by the mini-mental state examination;
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aged 65 or over
Exclusion Criteria:
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the presence of acute stroke/transient ischemic attack occurred in the 6 months prior to the enrollment visit;
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the presence of aphasia and/or neglect;
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the presence of other concomitants severe neurological/psychiatric diseases (e.g., hemiparesis, multiple system atrophy, muscular skeletal/orthopedic deficits that limit movement)
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the presence of physical and/or functional deficits;
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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);
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the history of head trauma with loss of consciousness
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recurrent vertigo.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cosimo Tuena | Milan | Lombardia | Italy | 20145 |
Sponsors and Collaborators
- Istituto Auxologico Italiano
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 39M202