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OpenTrials
Completed

NCT Number: NCT05768620

Active Navigation Training

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

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Key information

Conditions

Mild Cognitive Impairment Behavior Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Spatial Behavior Spatial Navigation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosimo Tuena

Milan, Lombardy, 20145, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAVE

Other

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

TAU

Other

This is the usual care used to train visuospatial processes

Primary outcomes

  1. Change in Corsi supra-span test

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

    Scores range from 0 to 29.16, higher scores indicate better visuospatial learning

  2. Change in Manikin Test

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

    Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation

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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: ANTaging

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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