NCT05768620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

February 22, 2023

Last Update Submit

November 24, 2023

Conditions

Mild Cognitive ImpairmentSpatial Navigation

Keywords

virtual reality

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Trail-making test part A and B

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

  • Raccontino (6 Dicembre) (immediate-delayed-forgetting)

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

  • Mini-mental state examination

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

  • Digit span forward

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

  • Corsi Block Tapping

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

Study Arms (2)

CAVE

EXPERIMENTAL

10 immersive virtual reality sessions to train spatial memory

Other: CAVE

TAU

ACTIVE COMPARATOR

10 paper and pencil sessions to train spatial memory

Other: TAU

Interventions

CAVEOTHER

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

CAVE
TAUOTHER

This is the usual care used to train visuospatial processes

TAU

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cosimo Tuena

Milan, Lombardy, 20145, Italy

Location

MeSH Terms

Conditions

Cognitive DysfunctionSpatial Navigation

Interventions

Caves

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSpatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Geological PhenomenaPhysical PhenomenaEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Proof-of-concept trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 14, 2023

Study Start

April 1, 2020

Primary Completion

April 1, 2023

Study Completion

July 1, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

IT(1)