Back to resultsActive Navigation Training (ANTaging)
Primary Purpose
Mild Cognitive Impairment, Spatial Navigation
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CAVE
TAU
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring virtual reality
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of mild cognitive impairment absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996) age ≥ 60 Exclusion Criteria: the presence of acute stroke/transient ischemic attack; the presence of other concomitants severe neurological/psychiatric diseases; history of traumatic brain injury with loss of consciousness; physical/functional deficits that could affect the use of immersive virtual reality; severe visual deficiency; the presence of recurrent vertigo.
Sites / Locations
- Cosimo TuenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAVE
TAU
Arm Description
10 immersive virtual reality sessions to train spatial memory
10 paper and pencil sessions to train spatial memory
Outcomes
Primary Outcome Measures
Change in Corsi supra-span test
Scores range from 0 to 29.16, higher scores indicate better visuospatial learning
Change in Manikin Test
Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation
Secondary Outcome Measures
Trail-making test part A and B
Raccontino (6 Dicembre) (immediate-delayed-forgetting)
Mini-mental state examination
Digit span forward
Corsi Block Tapping
Full Information
NCT ID
NCT05768620
First Posted
February 22, 2023
Last Updated
March 3, 2023
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT05768620
Brief Title
Active Navigation Training
Acronym
ANTaging
Official Title
Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 2023 (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
Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Spatial Navigation
Keywords
virtual reality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Proof-of-concept trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAVE
Arm Type
Experimental
Arm Description
10 immersive virtual reality sessions to train spatial memory
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
10 paper and pencil sessions to train spatial memory
Intervention Type
Other
Intervention Name(s)
CAVE
Intervention Description
The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
This is the usual care used to train visuospatial processes
Primary Outcome Measure Information:
Title
Change in Corsi supra-span test
Description
Scores range from 0 to 29.16, higher scores indicate better visuospatial learning
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Title
Change in Manikin Test
Description
Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary Outcome Measure Information:
Title
Trail-making test part A and B
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Title
Raccontino (6 Dicembre) (immediate-delayed-forgetting)
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Title
Mini-mental state examination
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Title
Digit span forward
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Title
Corsi Block Tapping
Time Frame
After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of mild cognitive impairment
absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
age ≥ 60
Exclusion Criteria:
the presence of acute stroke/transient ischemic attack;
the presence of other concomitants severe neurological/psychiatric diseases;
history of traumatic brain injury with loss of consciousness;
physical/functional deficits that could affect the use of immersive virtual reality;
severe visual deficiency;
the presence of recurrent vertigo.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cosimo Tuena
Phone
+390261911
Ext
2892
Email
c.tuena@auxologico.it
Facility Information:
Facility Name
Cosimo Tuena
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20145
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cosimo Tuena
12. IPD Sharing Statement
Learn more about this trial
Active Navigation Training
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