Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility

NCT07456475 | Active Not Recruiting

• 1 other identifier: F/350201/01-04/X60
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurological Disorder; Multiple Sclerosis; Parkinson Disease; Stroke; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Language

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

• Working memory and attention

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

• Visual-spatial ability

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

• Social metrics

  Measure recorded during all rehabilitative sessions (6 weeks)

• Emotional state

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

Study Arms (1)

Arm End-Users

EXPERIMENTAL

Acceptability evaluation of TERSICORE digital platform

Device: Cognitive rehabilitation with TERSICORE digital platform

Interventions

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).

Arm End-Users

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fondazione Don Gnocchi

Milan, Italy

Location

MeSH Terms

Conditions

Nervous System Diseases; Multiple Sclerosis; Parkinson Disease; Stroke; Brain Injuries, Traumatic

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 6, 2026
• Study Start: June 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Locations

IT (1)