Neurological DisorderTERSICORE XRMNCT07456475
Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility
A study testing Cognitive rehabilitation with TERSICORE digital platform in people with Neurological Disorder and Multiple Sclerosis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Disorder, Multiple Sclerosis, Parkinson Disease
- What is being tested?
- Cognitive rehabilitation with TERSICORE digital platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neurological Disorder, Multiple Sclerosis, Parkinson Disease, Stroke, Traumatic Brain Injury
- Being tested
- Cognitive rehabilitation with TERSICORE digital platform
- Medical subject headings
- Nervous System Diseases, Multiple Sclerosis, Parkinson Disease, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation with TERSICORE digital platformDevice
Small groups of end-users will participate in various cognitive tasks carried out in common virtual environments (Metaverse).
| Study group | Role | What they receive |
|---|---|---|
| Arm End-Users | Experimental | Acceptability evaluation of TERSICORE digital platform Receives: Device: Cognitive rehabilitation with TERSICORE digital platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: Measured at discharge or 7 days post baseline
Secondary outcomes (9)
Language
Changes in phonemic/semantic language ability as assessed by Verbal Fluency
Measured: 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: 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: 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
Measured: 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: 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: 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: 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: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Episodic memory
Changes in episodic memory as assessed by FCRST
Measured: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start6 Jun 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- H.S.P.I. s.p.a., Catholic University of the Sacred Heart, Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Principal investigator, Antonio Cerasa, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456475
- Sponsor's protocol ID
- F/350201/01-04/X60
- Acronym
- TERSICORE XRM
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Rehabilitation Solutions With Innovative Cores of Extended Reality Based on Metaverse
- ClinicalTrials.gov ID
- NCT07456475
- Acronym / sponsor ID
- TERSICORE XRM / F/350201/01-04/X60
- Conditions
- Neurological Disorder, Multiple Sclerosis, Parkinson Disease, Stroke, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- H.S.P.I. s.p.a., Catholic University of the Sacred Heart, Fondazione Don Carlo Gnocchi ETS
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm End-Users | Experimental | Device: Cognitive rehabilitation with TERSICORE digital platformAcceptability evaluation of TERSICORE digital platform |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation with TERSICORE digital platformSmall groups of end-users will participate in various cognitive tasks carried out in common virtual environments (Metaverse). | Device | Arm End-Users |
Primary outcome
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.
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
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.
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.
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.
9 secondary outcomes
Language
Time frame: Measured at baseline and at the end of the rehabilitation sessions (6 weeks)
Working memory and attention
Time frame: Measured at before and at the end of the rehabilitation sessions (6 weeks)
Visual-spatial ability
Time frame: Measured at before and at the end of the rehabilitation sessions (6 weeks)
Social metrics
Time frame: Measure recorded during all rehabilitative sessions (6 weeks)
Emotional state
Time frame: Measured at baseline and at the end of the rehabilitation sessions (6 weeks)
Social cognition
Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Gross manual dexterity level
Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Global cognitive functioning
Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Episodic memory
Time frame: Measured at baseline and at the end the rehabilitation sessions (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation with TERSICORE digital platform in people with Neurological Disorder and Multiple Sclerosis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Acceptability of Intervention as assessed by TAM3 (Technology Acceptance Model 3) questionnaire. (time frame: Measured at discharge or 7 days post baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.