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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05768620
Other study ID # 39M801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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