Virtual Reality Rehabilitation for Cognitive, Emotional, and Motor Recovery in Neurological Disorders (NeuroVR)

IRCCS Centro Neurolesi Bonino Pulejo

Status: Active, not recruiting

Conditions: Multiple Sclerosis; Parkinson Disease; Acquired Brain Injuries; Spinal Cord Injury

Treatments: Other: traditional cognitive and motor rehabilitation following standard clinical practices; Device: VR Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06838975

NEURO_VR

Current Research Funds 2025 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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328 participants in 2 patient groups

VR Training Group

Experimental group

Description:

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.

Treatment:

Device: VR Training

Active Control Group

Active Comparator group

Description:

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.

Treatment:

Other: traditional cognitive and motor rehabilitation following standard clinical practices