CClinicalTrials.gg
Active, not recruitingNCT07456475TERSICORE XRMUpdated Mar 6, 2026

Metaverse Applications in Clinical Neurorehabiliation: Device Feasibility

An interventional study of Cognitive rehabilitation with TERSICORE digital platform in Neurological Disorder, Multiple Sclerosis and Parkinson Disease, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neurological Disorder
  • Multiple Sclerosis
  • Parkinson Disease
  • Stroke
  • Traumatic Brain Injury
03

In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's planned enrollment of 25 is below the median of 48 across 623 interventional studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 46 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Arm End-Users

    Acceptability evaluation of TERSICORE digital platform

    Device: Cognitive rehabilitation with TERSICORE digital platform

Interventions

  • DeviceCognitive rehabilitation with TERSICORE digital platform

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at discharge or 7 days post baseline

  2. 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

    Time frame: Measured at discharge or 7 days post baseline

  3. 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.

    Time frame: Measured at discharge or 7 days post baseline

  4. 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.

    Time frame: Measured at discharge or 7 days post baseline

  5. 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.

    Time frame: Measured at discharge or 7 days post baseline

Secondary outcomes

  1. Language

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

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

  2. Working memory and attention

    Changes in executive functioning as assessed by Trial Making Test

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

  3. Visual-spatial ability

    Changes in visual-spatial ability as assessed by Rey Figure

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

  4. Social metrics

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

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

  5. Emotional state

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

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

  6. Social cognition

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

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

  7. Gross manual dexterity level

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

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

  8. Global cognitive functioning

    Changes in general cognitive funtioning as assessed by MoCA

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

  9. Episodic memory

    Changes in episodic memory as assessed by FCRST

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

07

Study locations

1 site
  • Fondazione Don Gnocchi
    Milan, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07456475
Lead sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators
H.S.P.I. s.p.a., Catholic University of the Sacred Heart, Fondazione Don Carlo Gnocchi ETS
Responsible party
Antonio Cerasa (Director, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy) — Principal investigator
First posted
Mar 6, 2026
Start date
Jun 6, 2025
Primary completion
Apr 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Mar 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion