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Active, Not Recruiting

NCT Number: NCT07456475

Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility

The main objective of the TERSICORE project is the development of a new advanced set of exergames in the Metaverse that can be used in all clinical and home rehabilitation devices to improve the cognitive therapy of neurological patients by exploiting the potential of social rehabilitation. Five specific exargames will be developed: a) Cooking therapy (Coordinating in a kitchen to complete a dish through shared activities); b) Escape Room (Exiting a simulated room by solving problems and logic puzzles); c) Nostalgia Bits (Sharing personal reminiscence narratives within simulated spaces); d) NeuroTeam (Mindfulness); and e) Truman Show Exploration of an urban space and role-playing.

All exargames will be validated on a small population of neurological patients according to cognitive profile.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neurological Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Stroke Synucleinopathies Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Gnocchi

Milan, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for patients:

  • Adult age: 18-85 years
  • Education: at least 5 years
  • Cognitive deficits at routine outpatient clinical neuropsychological assessment (at least one test with p.e. 0/1) in subjects with focal neurological insult - (post-Stroke, post-Cranial Trauma)
  • neurodegenerative disorders - (Multiple Sclerosis, Parkinson's, Mild Cognitive Impairment, AD-like)

Exclusion criteria

for patients:

  • Severe cognitive impairment MMSE <22
  • Presence of severe deficits in visual acuity, hearing perception, communication and severe dysmetria, such as to interfere with the administration of the activities proposed by TERSICORE
  • Presence of major psychiatric or neurological pathologies other than the inclusion criteria

Treatment and study plan

Cognitive rehabilitation with TERSICORE digital platform

Device

Small groups of end-users will participate in various cognitive tasks carried out in common virtual environments (Metaverse).

Primary outcomes

  1. Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire.

    Time frame: Measured at discharge or 7 days post baseline

    Number of participants with high level of behavioral intention (TAM3 score range 1-7), with higher scores indicating greater acceptability of intervention.

  2. Feasibility: Perceived usability of a technological system or application as assessed by SUS (System Usability Scale)

    Time frame: Measured at discharge or 7 days post baseline

    Number of participants with high level of high level of behavioral intention (SUS score range 1-5), high score indicating greater perceived usability of a technological system or application

  3. Feasibility: User experience of intervention as assessed by UEQ (User Experience Questionnaire)

    Time frame: Measured at discharge or 7 days post baseline

    Number of participants with high level of comprehensive impression of user experience (UEQ score range 1-7), with higher scores indicating greater impression of user experience.

  4. Feasibility: Intrinsic motivation as assessed by IMI subscale (Intrinsic Motivation Inventory).

    Time frame: Measured at discharge or 7 days post baseline

    Number of participants with high level of behavioral intention (IMI score range 1-7), with higher scores indicating greater intrinsic motivation.

  5. Feasibility: Sickness elicited by modern virtual reality systems as assessed by SSQ (Simulator Sickness Questionnaire).

    Time frame: Measured at discharge or 7 days post baseline

    Number of subjects with high level of sickness (SSQ score range 0-3), with higher scores indicating greater simulator sickness.

Secondary outcomes

  1. Language

    Time frame: Measured at baseline and at the end of the rehabilitation sessions (6 weeks)

    Changes in phonemic/semantic language ability as assessed by Verbal Fluency

  2. Working memory and attention

    Time frame: Measured at before and at the end of the rehabilitation sessions (6 weeks)

    Changes in executive functioning as assessed by Trial Making Test

  3. Visual-spatial ability

    Time frame: Measured at before and at the end of the rehabilitation sessions (6 weeks)

    Changes in visual-spatial ability as assessed by Rey Figure

  4. Social metrics

    Time frame: Measure recorded during all rehabilitative sessions (6 weeks)

    Proximity, frequency of interactions, synchrony and coordination. All these parameters will be measured by sensors

  5. Emotional state

    Time frame: Measured at baseline and at the end of the rehabilitation sessions (6 weeks)

    Changes in positive and negative affective states as assessed by Positive and Negative Affect Schedule

  6. Social cognition

    Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)

    Changes in theory of mind ability as assessed by Yoni task-48

  7. Gross manual dexterity level

    Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)

    Changes in gross manual dexterity level as assessed by Box and Block

  8. Global cognitive functioning

    Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)

    Changes in general cognitive funtioning as assessed by MoCA

  9. Episodic memory

    Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)

    Changes in episodic memory as assessed by FCRST

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Catholic University of the Sacred Heart
  • Fondazione Don Carlo Gnocchi ETS
  • H.S.P.I. s.p.a.

Registry information

Official study title

Tele-Rehabilitation Solutions With Innovative Cores of Extended Reality Based on Metaverse

Acronym: TERSICORE XRM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

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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