Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility (TERSICORE XRM)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Multiple Sclerosis; Parkinson Disease; Traumatic Brain Injury; Neurological Disorder
• Intervention / Treatment: Device: Cognitive rehabilitation with TERSICORE digital platform

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Fondazione Don Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm End-Users; Acceptability evaluation of TERSICORE digital platform	Device: Cognitive rehabilitation with TERSICORE digital platform; Small groups of end-users will participate in various cognitive tasks carried out in common virtual environments (Metaverse).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire.	Number of participants with high level of behavioral intention (TAM3 score range 1-7), with higher scores indicating greater acceptability of intervention.	Measured at discharge or 7 days post baseline
Feasibility: Perceived usability of a technological system or application as assessed by SUS (System Usability Scale)	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	Measured at discharge or 7 days post baseline
Feasibility: User experience of intervention as assessed by UEQ (User Experience Questionnaire)	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.	Measured at discharge or 7 days post baseline
Feasibility: Intrinsic motivation as assessed by IMI subscale (Intrinsic Motivation Inventory).	Number of participants with high level of behavioral intention (IMI score range 1-7), with higher scores indicating greater intrinsic motivation.	Measured at discharge or 7 days post baseline
Feasibility: Sickness elicited by modern virtual reality systems as assessed by SSQ (Simulator Sickness Questionnaire).	Number of subjects with high level of sickness (SSQ score range 0-3), with higher scores indicating greater simulator sickness.	Measured at discharge or 7 days post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Language	Changes in phonemic/semantic language ability as assessed by Verbal Fluency	Measured at baseline and at the end of the rehabilitation sessions (6 weeks)
Working memory and attention	Changes in executive functioning as assessed by Trial Making Test	Measured at before and at the end of the rehabilitation sessions (6 weeks)
Visual-spatial ability	Changes in visual-spatial ability as assessed by Rey Figure	Measured at before and at the end of the rehabilitation sessions (6 weeks)
Social metrics	Proximity, frequency of interactions, synchrony and coordination. All these parameters will be measured by sensors	Measure recorded during all rehabilitative sessions (6 weeks)
Emotional state	Changes in positive and negative affective states as assessed by Positive and Negative Affect Schedule	Measured at baseline and at the end of the rehabilitation sessions (6 weeks)
Social cognition	Changes in theory of mind ability as assessed by Yoni task-48	Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Gross manual dexterity level	Changes in gross manual dexterity level as assessed by Box and Block	Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Global cognitive functioning	Changes in general cognitive funtioning as assessed by MoCA	Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Episodic memory	Changes in episodic memory as assessed by FCRST	Measured at baseline and at the end the rehabilitation sessions (6 weeks)

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
• Collaborators: Catholic University of the Sacred Heart; Fondazione Don Carlo Gnocchi Onlus; H.S.P.I. s.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Craniocerebral Trauma; Trauma, Nervous System; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Injuries; Brain Injuries, Traumatic; Stroke; Multiple Sclerosis; Parkinson Disease; Nervous System Diseases; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Neurological Rehabilitation; Cognitive Training
• Other Study ID Numbers: F/350201/01-04/X60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No