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NCT Number: NCT06079411

Virtual Therapeutics for MCI

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano

Milan, Lombardy, 20145, Italy

Location status: Recruiting

Location contact

Cosimo Tuena

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Treatment as Usual

Other

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

Primary outcomes

  1. The long-term visuospatial memory scores from Corsi supra span

    Time frame: 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)

    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.

  2. the spatial rotation score from the Manikin Test

    Time frame: 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)

    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.

Secondary outcomes

  1. the cognitive global scores from Mini Mental State Examination

    Time frame: 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)

    A lower score in Mini Mental State Examination represents a worse symptom severity. The minimum score is 0, and the maximum score is equal to 30. Scores will be corrected for age and education.

  2. The verbal memory scores from the Babcock test

    Time frame: 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)

    A lower score in the Babcock test represents a worse symptom severity. The minimum score is 0, and the maximum score is equal to 8 for the immediate score; The minimum score is 0, and the maximum score is equal to 8 for the delayed score. Scores will be corrected for age and education

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

    Time frame: 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)

    A lower score in the Corsi Block Tapping Test- Forward represents a worse symptom severity. The minimum score is 3, and the maximum score is equal to 9. Scores will be corrected for age and education.

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

    Time frame: 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)

    A lower score in the Corsi Block Tapping Test- Backward represents a worse symptom severity. The minimum score is 3, and the maximum score is equal to 8. Scores will be corrected for age and education.

  5. The attention and executive functions score from the Trail Making Test

    Time frame: 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)

    A higher score in the Trail Making Test represents a worse symptom severity. The minimum score is 0 and no time limit for the maximum score for Trail Making Test part A, Trail Making Test part B and Trail Making Test part BA scores.

  6. the visuospatial score from the Clock Drawing Test

    Time frame: 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)

    A lower score in the Clock Drawing Test represented a worse symptom severity. The minimum score is 0, and the maximum score is equal to 13.

  7. the spatial rotation score from the Money Roadmap test

    Time frame: 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)

    A lower score in the Money Roadmap test represented a worse symptom severity. The minimum score is 0, and the maximum score is equal to 32.

  8. Subjective Subjective Spatial Navigation Complaints sub-scale number 7

    Time frame: 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)

    A higher score in Subjective Spatial Navigation Complaints represented a worse symptom severity. The minimum score is 0, and the maximum score is 3.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Stramba-Badiale

CONTACT

[email protected]

Cosimo Tuena

CONTACT

[email protected]

0261911 ext. 2726

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Istituto Superiore di Sanità
  • University of Turin, Italy

Registry information

Official study title

Low-Cost Virtual Therapeutics and Digital Biomarkers for the Early Assessment and Personalized Treatment of Mild Cognitive Impairment

Acronym: VR-MCI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Mar 8, 2024

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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