Acquired Brain InjuriesNeuroVRNCT06838975
Virtual Reality Rehabilitation for Cognitive, Emotional, and Motor Recovery in Neurological Disorders
A study testing VR Training and traditional cognitive and motor rehabilitation following standard clinical practices in people with Acquired Brain Injuries and Spinal Cord Injury, run by IRCCS Centro Neurolesi Bonino Pulejo at 2 sites in Italy.
Trial summary
This randomized controlled trial (RCT) evaluates the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological disorders (ABI, SCI, MS, PD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injuries, Spinal Cord Injury, Multiple Sclerosis
- What is being tested?
- VR Training and traditional cognitive and motor rehabilitation following standard clinical practices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Jan 2025to 31 Jan 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years
- Diagnosis:
- Parkinson's Disease (PD) (MDS Clinical Diagnostic Criteria) Multiple Sclerosis (MS) (McDonald Criteria) Spinal Cord Injury (SCI) (ASIA Impairment Scale) Acquired Brain Injury (ABI) (WHO Criteria for Stroke)
- Education: Minimum of 5 years of formal education
- Cognitive and physical ability to engage in rehabilitation
Who cannot join
- Major psychiatric disorders (e.g., psychosis, severe depression, anxiety disorders)
- Severe medical conditions that impair participation
- Sensory or motor impairments preventing VR interaction
- Contraindications for MRI (e.g., pacemakers, incompatible implants)
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Me, 98123
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Me, 98124
About this study
Official title: Effectiveness of Virtual Reality Rehabilitation to Improve Cognitive, Emotional, Relational, and Motor Domains in Patients With Neurological and Neurodegenerative Disorders
This randomized controlled trial (RCT) evaluates the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological disorders (ABI, SCI, MS, PD). It investigates whether VR improves motor and cognitive functions more than traditional therapy, identifies neurophysiological changes (EEG, fNIRS, MRI), and assesses the integration of VR with NIBS or telerehabilitation. Conducted over three years at IRCCS Centro Neurolesi Bonino Pulejo, participants are randomly assigned to either a VR training group or an active control group receiving traditional rehabilitation. Procedures include baseline assessments (T0), 20 rehabilitation sessions over 8 weeks, post-intervention evaluations (T1), and a 3-month follow-up (T2). Primary outcomes measure motor and cognitive function (MoCA, MMSE, FIM, TUG, Berg Balance Scale), neurophysiological changes (EEG, MRI, fNIRS, motion analysis), and emotional/social function (Empathy Quotient, Hamilton Depression Scale).
Read the detailed description
This randomized controlled trial (RCT) aims to evaluate the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological and neurodegenerative disorders (Acquired Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis, and Parkinson's Disease). The study also explores neurophysiological changes and the potential benefits of combining VR with non-invasive brain stimulation (NIBS) and telerehabilitation.
Objectives:
Primary Objectives:
Assess the effectiveness of VR-based rehabilitation in enhancing cognitive and motor functions.
Identify neurophysiological changes (EEG, fNIRS, MRI) associated with functional recovery.
Secondary Objectives:
Identify behavioral and neurophysiological biomarkers predictive of rehabilitation outcomes.
Compare the effectiveness of different VR devices for rehabilitation. Evaluate the impact of VR telerehabilitation on recovery and continuity of care.
Explore the synergistic effects of VR combined with NIBS.
Methods:
Study Site: IRCCS Centro Neurolesi Bonino Pulejo. Duration: 3 years. Participants: 328 individuals with neurological disorders (18-75 years old).
Design:
Participants will be randomized into two groups:
VR Training Group: Engages in immersive VR-based rehabilitation. Active Control Group: Receives conventional therapy. Sessions: 20 sessions over 8 weeks (3 times per week).
Assessments at 3 time points:
T0 (Baseline): Neurological, neuropsychological, motor, and neurophysiological evaluations.
T1 (Post-intervention): Repeat assessments to measure immediate effects. T2 (Follow-up at 3 months): Evaluate the maintenance of improvements.
Assessments \& Outcome Measures:
Cognitive Function: MoCA, MMSE, ACE-R, Rao's Battery. Motor Function: Functional Independence Measure (FIM), TUG, Tinetti Scale, Berg Balance Scale.
Neurophysiological Changes: EEG, fNIRS, MRI, eye-tracking, motion analysis, sEMG.
Emotional \& Social Function: Short Empathy Quotient (EQ-short), Faux Pas Test, Hamilton Depression Scale.
Usability \& Acceptance: System Usability Scale (SUS).
Expected Impact:
This study aims to advance personalized rehabilitation strategies, improve accessibility to innovative therapies (e.g., telerehabilitation), and optimize the use of VR-based interventions in clinical practice.
- Being tested
- VR Training, traditional cognitive and motor rehabilitation following standard clinical practices
- Keywords
- Neurorehabilitation, Virtual Reality, Cognitive and motor recovery, cognitive rehabilitation, neurological disorders
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Parkinson Disease, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR TrainingDevice
Also called Experimental Group
Participants in the VR Training Group will undergo a virtual reality-based rehabilitation program designed to improve cognitive, emotional, social, and motor functions. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), using immersive and non-immersive VR systems tailored to individual needs. The program integrates interactive exercises, real-time feedback, and task-oriented training to enhance motor function, cognitive abilities, and patient engagement. Neurophysiological changes will be monitored through EEG, MRI, and motion analysis to assess brain plasticity and functional improvements.
traditional cognitive and motor rehabilitation following standard clinical practicesOther
Participants in the Active Control Group will receive traditional cognitive and motor rehabilitation following standard clinical practices. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), focusing on conventional physical therapy, cognitive training, and task-oriented exercises to enhance motor function and cognitive abilities. This group serves as a comparison to evaluate the effectiveness of VR-based rehabilitation. Neurophysiological changes will be monitored using EEG, MRI, and motion analysis to assess functional improvements.
| Study group | Role | What they receive |
|---|---|---|
| VR Training Group | Experimental | Participants in the VR Training Group will undergo a virtual reality-based rehabilitation program designed to improve cognitive, emotional, social, and motor functions. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), using immersive and non-immersive VR systems tailored to individual needs. The program integrates interactive exercises, real-time feedback, and task-oriented training to enhance motor function, cognitive abilities, and patient engagement. Neurophysiological changes will be monitored through EEG, MRI, and motion analysis to assess brain plasticity and functional improvements. Receives: Device: VR Training |
| Active Control Group | Active comparator | Participants in the Active Control Group will receive traditional cognitive and motor rehabilitation following standard clinical practices. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), focusing on conventional physical therapy, cognitive training, and task-oriented exercises to enhance motor function and cognitive abilities. This group serves as a comparison to evaluate the effectiveness of VR-based rehabilitation. Neurophysiological changes will be monitored using EEG, MRI, and motion analysis to assess functional improvements. Receives: Other: traditional cognitive and motor rehabilitation following standard clinical practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Cognitive Function
Change in cognitive function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized neuropsychological tests (Montreal Cognitive Assessment - MOCA). A clinically significant improvement is defined as a measurable increase in at least two subscales of the respective cognitive tests.
Measured: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Improvement in Motor Function
Change in motor function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized clinical tests, including the Berg Balance Scale. A clinically significant improvement is defined as a measurable increase in functional mobility and balance scores.
Measured: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Secondary outcomes (2)
Neurophysiological Changes Associated with Rehabilitation
Change in neurophysiological markers from baseline (T0) to post-intervention (T1) and follow-up (T2), assessed through EEG. Significant changes will be identified based on increased functional connectivity and structural adaptations indicative of neuroplasticity.
Measured: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Effectiveness of Telerehabilitation
Comparison of functional improvements between participants receiving VR-based rehabilitation in clinical settings versus those undergoing a telerehabilitation protocol. Changes in motor and cognitive function will be assessed from baseline (T0) to post-intervention (T1) and follow-up (T2) using MoCA. Accessibility, adherence, and patient-reported outcomes will also be analyzed to evaluate the feasibility and effectiveness of remote VR-based rehabilitation.
Measured: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start16 Jan 2025
- Primary completion29 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a randomized controlled trial (RCT) design with a parallel assignment model, where participants are randomly allocated to either a VR-based rehabilitation group or a traditional rehabilitation control group. The intervention consists of 20 sessions over 8 weeks, with follow-up assessments at post-intervention (T1) and 3 months (T2). Blinded evaluators will conduct neurological, cognitive, motor, and neurophysiological assessments (EEG, MRI, fNIRS, motion analysis) at each time point. This model allows for a rigorous comparison of VR rehabilitation with conventional therapy, examining its effects on functional recovery, neurophysiological changes, and treatment adherence.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Maggio, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Maria Grazia Maggio, PhD, PsyD, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838975
- Sponsor's protocol ID
- NEURO_VR
- Other IDs
- Current Research Funds 2025
- Acronym
- NeuroVR
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.
Publications
Maggio MG, Maresca G, De Luca R, Stagnitti MC, Porcari B, Ferrera MC, Galletti F, Casella C, Manuli A, Calabro RS. The Growing Use of Virtual Reality in Cognitive Rehabilitation: Fact, Fake or Vision? A Scoping Review. J Natl Med Assoc. 2019 Aug;111(4):457-463. doi: 10.1016/j.jnma.2019.01.003. Epub 2019 Feb 8.
PubMed 30739728De Luca R, Russo M, Naro A, Tomasello P, Leonardi S, Santamaria F, Desiree L, Bramanti A, Silvestri G, Bramanti P, Calabro RS. Effects of virtual reality-based training with BTs-Nirvana on functional recovery in stroke patients: preliminary considerations. Int J Neurosci. 2018 Sep;128(9):791-796. doi: 10.1080/00207454.2017.1403915. Epub 2018 Feb 2.
PubMed 29148855Maggio MG, Bonanno M, Manuli A, Onesta MP, De Luca R, Quartarone A, Calabro RS. Do Individuals with Spinal Cord Injury Benefit from Semi-Immersive Virtual Reality Cognitive Training? Preliminary Results from an Exploratory Study on an Underestimated Problem. Brain Sci. 2023 Jun 13;13(6):945. doi: 10.3390/brainsci13060945.
PubMed 37371423
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Rehabilitation to Improve Cognitive, Emotional, Relational, and Motor Domains in Patients With Neurological and Neurodegenerative Disorders
- ClinicalTrials.gov ID
- NCT06838975
- Acronym / sponsor ID
- NeuroVR / NEURO_VR
- Keywords
- Neurorehabilitation, Virtual Reality, Cognitive and motor recovery, cognitive rehabilitation, neurological disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 328 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 21 Feb 2025 (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.
This randomized controlled trial (RCT) evaluates the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological disorders (ABI, SCI, MS, PD). It investigates whether VR improves motor and cognitive functions more than traditional therapy, identifies neurophysiological changes (EEG, fNIRS, MRI), and assesses the integration of VR with NIBS or telerehabilitation. Conducted over three years at IRCCS Centro Neurolesi Bonino Pulejo, participants are randomly assigned to either a VR training group or an active control group receiving traditional rehabilitation. Procedures include baseline assessments (T0), 20 rehabilitation sessions over 8 weeks, post-intervention evaluations (T1), and a 3-month follow-up (T2). Primary outcomes measure motor and cognitive function (MoCA, MMSE, FIM, TUG, Berg Balance Scale), neurophysiological changes (EEG, MRI, fNIRS, motion analysis), and emotional/social function (Empathy Quotient, Hamilton Depression Scale).
Detailed description
This randomized controlled trial (RCT) aims to evaluate the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological and neurodegenerative disorders (Acquired Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis, and Parkinson's Disease). The study also explores neurophysiological changes and the potential benefits of combining VR with non-invasive brain stimulation (NIBS) and telerehabilitation.
Objectives:
Primary Objectives:
Assess the effectiveness of VR-based rehabilitation in enhancing cognitive and motor functions.
Identify neurophysiological changes (EEG, fNIRS, MRI) associated with functional recovery.
Secondary Objectives:
Identify behavioral and neurophysiological biomarkers predictive of rehabilitation outcomes.
Compare the effectiveness of different VR devices for rehabilitation. Evaluate the impact of VR telerehabilitation on recovery and continuity of care.
Explore the synergistic effects of VR combined with NIBS.
Methods:
Study Site: IRCCS Centro Neurolesi Bonino Pulejo. Duration: 3 years. Participants: 328 individuals with neurological disorders (18-75 years old).
Design:
Participants will be randomized into two groups:
VR Training Group: Engages in immersive VR-based rehabilitation. Active Control Group: Receives conventional therapy. Sessions: 20 sessions over 8 weeks (3 times per week).
Assessments at 3 time points:
T0 (Baseline): Neurological, neuropsychological, motor, and neurophysiological evaluations.
T1 (Post-intervention): Repeat assessments to measure immediate effects. T2 (Follow-up at 3 months): Evaluate the maintenance of improvements.
Assessments \& Outcome Measures:
Cognitive Function: MoCA, MMSE, ACE-R, Rao's Battery. Motor Function: Functional Independence Measure (FIM), TUG, Tinetti Scale, Berg Balance Scale.
Neurophysiological Changes: EEG, fNIRS, MRI, eye-tracking, motion analysis, sEMG.
Emotional \& Social Function: Short Empathy Quotient (EQ-short), Faux Pas Test, Hamilton Depression Scale.
Usability \& Acceptance: System Usability Scale (SUS).
Expected Impact:
This study aims to advance personalized rehabilitation strategies, improve accessibility to innovative therapies (e.g., telerehabilitation), and optimize the use of VR-based interventions in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study follows a randomized controlled trial (RCT) design with a parallel assignment model, where participants are randomly allocated to either a VR-based rehabilitation group or a traditional rehabilitation control group. The intervention consists of 20 sessions over 8 weeks, with follow-up assessments at post-intervention (T1) and 3 months (T2). Blinded evaluators will conduct neurological, cognitive, motor, and neurophysiological assessments (EEG, MRI, fNIRS, motion analysis) at each time point. This model allows for a rigorous comparison of VR rehabilitation with conventional therapy, examining its effects on functional recovery, neurophysiological changes, and treatment adherence.
| Arm | Type | Receives |
|---|---|---|
| VR Training Group | Experimental | Device: VR TrainingParticipants in the VR Training Group will undergo a virtual reality-based rehabilitation program designed to improve cognitive, emotional, social, and motor functions. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), using immersive and non-immersive VR systems tailored to individual needs. The program integrates interactive exercises, real-time feedback, and task-oriented training to enhance motor function, cognitive abilities, and patient engagement. Neurophysiological changes will be monitored through EEG, MRI, and motion analysis to assess brain plasticity and functional improvements. |
| Active Control Group | Active comparator | Other: traditional cognitive and motor rehabilitation following standard clinical practicesParticipants in the Active Control Group will receive traditional cognitive and motor rehabilitation following standard clinical practices. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), focusing on conventional physical therapy, cognitive training, and task-oriented exercises to enhance motor function and cognitive abilities. This group serves as a comparison to evaluate the effectiveness of VR-based rehabilitation. Neurophysiological changes will be monitored using EEG, MRI, and motion analysis to assess functional improvements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 75 years
- Diagnosis:
- Parkinson's Disease (PD) (MDS Clinical Diagnostic Criteria) Multiple Sclerosis (MS) (McDonald Criteria) Spinal Cord Injury (SCI) (ASIA Impairment Scale) Acquired Brain Injury (ABI) (WHO Criteria for Stroke)
- Education: Minimum of 5 years of formal education
- Cognitive and physical ability to engage in rehabilitation
Key exclusion criteria (5 listed)
- Major psychiatric disorders (e.g., psychosis, severe depression, anxiety disorders)
- Severe medical conditions that impair participation
- Sensory or motor impairments preventing VR interaction
- Contraindications for MRI (e.g., pacemakers, incompatible implants)
- Pregnancy
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 |
|---|---|---|
| VR TrainingAlso: Experimental GroupParticipants in the VR Training Group will undergo a virtual reality-based rehabilitation program designed to improve cognitive, emotional, social, and motor functions. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), using immersive and non-immersive VR systems tailored to individual needs. The program integrates interactive exercises, real-time feedback, and task-oriented training to enhance motor function, cognitive abilities, and patient engagement. Neurophysiological changes will be monitored through EEG, MRI, and motion analysis to assess brain plasticity and functional improvements. | Device | VR Training Group |
| traditional cognitive and motor rehabilitation following standard clinical practicesParticipants in the Active Control Group will receive traditional cognitive and motor rehabilitation following standard clinical practices. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), focusing on conventional physical therapy, cognitive training, and task-oriented exercises to enhance motor function and cognitive abilities. This group serves as a comparison to evaluate the effectiveness of VR-based rehabilitation. Neurophysiological changes will be monitored using EEG, MRI, and motion analysis to assess functional improvements. | Other | Active Control Group |
Primary outcome
Improvement in Cognitive Function
Time frame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Change in cognitive function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized neuropsychological tests (Montreal Cognitive Assessment - MOCA). A clinically significant improvement is defined as a measurable increase in at least two subscales of the respective cognitive tests.
Improvement in Motor Function
Time frame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Change in motor function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized clinical tests, including the Berg Balance Scale. A clinically significant improvement is defined as a measurable increase in functional mobility and balance scores.
2 secondary outcomes
Neurophysiological Changes Associated with Rehabilitation
Time frame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Effectiveness of Telerehabilitation
Time frame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention)
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 21 Feb 2025.
- Background: PubMed 30739728Maggio MG, Maresca G, De Luca R, Stagnitti MC, Porcari B, Ferrera MC, Galletti F, Casella C, Manuli A, Calabro RS. The Growing Use of Virtual Reality in Cognitive Rehabilitation: Fact, Fake or Vision? A Scoping Review. J Natl Med Assoc. 2019 Aug;111(4):457-463. doi: 10.1016/j.jnma.2019.01.003. Epub 2019 Feb 8.
- Background: PubMed 29148855De Luca R, Russo M, Naro A, Tomasello P, Leonardi S, Santamaria F, Desiree L, Bramanti A, Silvestri G, Bramanti P, Calabro RS. Effects of virtual reality-based training with BTs-Nirvana on functional recovery in stroke patients: preliminary considerations. Int J Neurosci. 2018 Sep;128(9):791-796. doi: 10.1080/00207454.2017.1403915. Epub 2018 Feb 2.
- Background: PubMed 37371423Maggio MG, Bonanno M, Manuli A, Onesta MP, De Luca R, Quartarone A, Calabro RS. Do Individuals with Spinal Cord Injury Benefit from Semi-Immersive Virtual Reality Cognitive Training? Preliminary Results from an Exploratory Study on an Underestimated Problem. Brain Sci. 2023 Jun 13;13(6):945. doi: 10.3390/brainsci13060945.
- Individual participant dataSharing planned: Yes. IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.
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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.
Maria Grazia Maggio, PhD, PsyD principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Training and traditional cognitive and motor rehabilitation following standard clinical practices in people with Acquired Brain Injuries and Spinal Cord Injury, run by IRCCS Centro Neurolesi Bonino Pulejo at 2 sites 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 5 inclusion and 5 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement in Cognitive Function (time frame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838975, which also lists 3 linked publications.
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 21 Feb 2025.