Virtual Therapeutics for MCI

NCT ID: NCT06079411

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The current study aims to design, develop and test virtual therapeutics to train MCI spatial memory through virtual reality rehabilitation. 36 Participants will be randomly assigned to three different conditions: embodied low-end spatial VR training vs. the treatment as usual (TAU; i.e., visuospatial "paper and pencil" stimulation) vs. a non-embodied low-end spatial VR training. The three conditions will consist of at least 8 sessions of 30/40 minutes 3 times a week.

The study will measure changes in spatial memory, in particular in egocentric and allocentric memory. Each patient will be tested 3 times: 3 weeks before the pre-test (control waiting period), at the pre-test and after the intervention, namely post-test (3 time points).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAU

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.

Group Type ACTIVE_COMPARATOR

treatment as usual

Intervention Type OTHER

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

VR non-embodied

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.

Group Type EXPERIMENTAL

virtual reality non-embodied

Intervention Type 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 embodied

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.

Group Type EXPERIMENTAL

virtual reality embodied

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

virtual reality non-embodied

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.

Intervention Type DEVICE

virtual reality embodied

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.

Intervention Type DEVICE

treatment as usual

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Superiore di Sanità

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Auxologico Italiano

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cosimo Tuena

Role: CONTACT

0261911 ext. 2726

Chiara Stramba-Badiale

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cosimo Tuena

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

39M202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.