CClinicalTrials.gg
CompletedNCT05768620ANTagingUpdated Nov 27, 2023

Active Navigation Training

An interventional study of CAVE and TAU in Mild Cognitive Impairment and Spatial Navigation, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Apr 2020, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Mild Cognitive Impairment
  • Spatial Navigation

Keywords

  • virtual reality
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 32 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    CAVE

    10 immersive virtual reality sessions to train spatial memory

    Other: CAVE

  • Active comparator
    TAU

    10 paper and pencil sessions to train spatial memory

    Other: TAU

Interventions

  • OtherCAVE

    The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes

  • OtherTAU

    This is the usual care used to train visuospatial processes

06

What researchers measure

Primary outcomes

  1. Change in Corsi supra-span test

    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

  2. Change in Manikin Test

    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 outcomes

  1. Trail-making test part A and B

    Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

  2. Raccontino (6 Dicembre) (immediate-delayed-forgetting)

    Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

  3. Mini-mental state examination

    Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

  4. Digit span forward

    Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

  5. Corsi Block Tapping

    Time frame: After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

07

Study locations

1 site
  • Cosimo Tuena
    Milan, Lombardia 20145, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05768620
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 14, 2023
Start date
Apr 1, 2020
Primary completion
Apr 1, 2023
Completion
Jul 1, 2023
Last update
Nov 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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