Virtual Therapeutics for MCI

NCT06079411 | Recruiting

• 1 other identifier: 39M202
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Mild Cognitive Impairment (MCI) is a term used to describe the transitional stage that occurs between normal aging and the onset of dementia. Spatial disorientation is often considered a significant indicator for diagnosing dementia. Numerous studies have documented deficits in both the allocentric and egocentric spatial frames of reference, as well as difficulties in transitioning between them, in individuals with MCI. Rapid advances in computing technology have enabled researchers to conduct cognitive training and rehabilitation interventions with the assistance of technology. Therefore, the aim of the study is to use virtual therapeutics to train MCI spatial memory.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• The long-term visuospatial memory scores from Corsi supra span

  A lower Corsi supra span score represents a lower visuospatial memory. The minimum score is 0.06 and the maximum is 29.16. Scores will be corrected for age and education and they depend on the score of the Corsi Block Tapping Test.

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

• the spatial rotation score from the Manikin Test

  A lower score in The Manikin test represents lower spatial rotation ability. The minimum score is 0, and the maximum score is equal to 30.

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

Secondary Outcomes (8)

• the cognitive global scores from Mini Mental State Examination

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

• The verbal memory scores from the Babcock test

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

• The short term visuospatial memory scores from the Corsi Block Tapping Test- Forward

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

• the visuospatial working memory scores from the Corsi Block Tapping Test- Backward

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

• The attention and executive functions score from the Trail Making Test

  change from waiting list to pre-test (after 3 weeks from waiting list) and post-test (after 6 weeks from waiting list) and change from pre-test to post-test (after 3 weeks from pre-test)

Study Arms (3)

TAU

ACTIVE COMPARATOR

the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises used in clinical routine of 8 sessions of 30/40 minutes 3 times a week.

Other: treatment as usual

VR non-embodied

EXPERIMENTAL

the non-embodied spatial training will consist of egocentric and allocentric spatial memory training with passive navigation of 8 sessions of 30/40 minutes 3 times a week.

Device: virtual reality non-embodied

VR embodied

EXPERIMENTAL

the embodied spatial training will consist of egocentric and allocentric spatial memory training with active navigation of 8 sessions of 30/40 minutes 3 times a week.

Device: virtual reality embodied

Interventions

virtual reality non-embodied DEVICE

the non-embodied virtual reality spatial training will consist of egocentric and allocentric spatial memory training with passive navigation of 8 sessions of 30/40 minutes 3 times a week.

VR non-embodied

virtual reality embodied DEVICE

the embodied virtual reality spatial training will consist of egocentric and allocentric spatial memory training with active navigation of 8 sessions of 30/40 minutes 3 times a week.

VR embodied

treatment as usual OTHER

the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) will consist of "paper and pencil" exercises

TAU

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• a change in cognition recognized by patients or observers (Caregiver/examiner)
• an objective impairment in one or more cognitive domains using traditional neuropsychological tests;
• autonomy or slight dependence on daily life activities;
• absence of diagnosis of dementia
• absence of cognitive impairment measured by the mini-mental state examination;
• aged 65 or over

You may not qualify if:

• the presence of acute stroke/transient ischemic attack occurred in the 6 months prior to the enrollment visit;
• the presence of aphasia and/or neglect;
• the presence of other concomitants severe neurological/psychiatric diseases (e.g., hemiparesis, multiple system atrophy, muscular skeletal/orthopedic deficits that limit movement)
• the presence of physical and/or functional deficits;
• the comorbidity with severe neurological and/or psychiatric diseases (e.g., neoplasms, multiple sclerosis, amyotrophic lateral sclerosis, Huntington's disease, schizophrenia, addiction, personality disorder, eating disorder) or with psychiatric conditions not under drug treatment (anxiety-depressive syndrome, bipolarism);
• the history of head trauma with loss of consciousness
• recurrent vertigo.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Istituto Superiore di Sanità: collaborator
• University of Turin, Italy: collaborator

Study Sites (1)

Istituto Auxologico Italiano

Milan, Lombardy, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Cosimo Tuena

CONTACT

0261911; c.tuena@auxologico.it

Chiara Stramba-Badiale

CONTACT

c.strambabadiale@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 12, 2023
• Study Start: October 17, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

IT (1)