Active Navigation Training

Mild Cognitive Impairment Clinical Trial

— ANTaging  

Official title:

Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768620
• Other study ID #: 39M801
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Spatial Navigation

Intervention

Other:
• CAVE
The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes
• TAU
This is the usual care used to train visuospatial processes

Locations

Country	Name	City	State
Italy	Cosimo Tuena	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Corsi supra-span test	Scores range from 0 to 29.16, higher scores indicate better visuospatial learning	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Primary	Change in Manikin Test	Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary	Trail-making test part A and B		After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary	Raccontino (6 Dicembre) (immediate-delayed-forgetting)		After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary	Mini-mental state examination		After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary	Digit span forward		After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Secondary	Corsi Block Tapping		After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up