Mild Cognitive Impairment Clinical Trial
— ANTagingOfficial title:
Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging
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 |
Verified date | November 2023 |
Source | Istituto Auxologico Italiano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Cosimo Tuena | Milan | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano |
Italy,
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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