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Virtual Therapeutics for MCI (VR-MCI)

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
virtual reality non-embodied
virtual reality embodied
treatment as usual
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cosimo Tuena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

TAU

VR non-embodied

VR embodied

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

The long-term visuospatial memory scores from Corsi supra span
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
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
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
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
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
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
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
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
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
A higher score in Subjective Spatial Navigation Complaints represented a worse symptom severity. The minimum score is 0, and the maximum score is 3.

Full Information

First Posted
September 26, 2023
Last Updated
October 5, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT06079411
Brief Title
Virtual Therapeutics for MCI
Acronym
VR-MCI
Official Title
Low-Cost Virtual Therapeutics and Digital Biomarkers for the Early Assessment and Personalized Treatment of Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU
Arm Type
Active Comparator
Arm 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.
Arm Title
VR non-embodied
Arm Type
Experimental
Arm 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.
Arm Title
VR embodied
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
virtual reality non-embodied
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
virtual reality embodied
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
treatment as usual
Intervention Description
the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises
Primary Outcome Measure Information:
Title
The long-term visuospatial memory scores from Corsi supra span
Description
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)
Title
the spatial rotation score from the Manikin Test
Description
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)
Secondary Outcome Measure Information:
Title
the cognitive global scores from Mini Mental State Examination
Description
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)
Title
The verbal memory scores from the Babcock test
Description
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)
Title
The short term visuospatial memory scores from the Corsi Block Tapping Test- Forward
Description
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)
Title
the visuospatial working memory scores from the Corsi Block Tapping Test- Backward
Description
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)
Title
The attention and executive functions score from the Trail Making Test
Description
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)
Title
the visuospatial score from the Clock Drawing Test
Description
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)
Title
the spatial rotation score from the Money Roadmap test
Description
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)
Title
Subjective Subjective Spatial Navigation Complaints sub-scale number 7
Description
A higher score in Subjective Spatial Navigation Complaints represented a worse symptom severity. The minimum score is 0, and the maximum score is 3.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cosimo Tuena
Phone
0261911
Ext
2726
Email
c.tuena@auxologico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Stramba-Badiale
Email
c.strambabadiale@auxologico.it
Facility Information:
Facility Name
Cosimo Tuena
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20145
Country
Italy

12. IPD Sharing Statement

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Virtual Therapeutics for MCI

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