Clinical trial NCT06838975: Virtual Reality Rehabilitation for Cognitive, Emotional, and Motor Recovery in Neurological Disorders
Official title: Effectiveness of Virtual Reality Rehabilitation to Improve Cognitive, Emotional, Relational, and Motor Domains in Patients With Neurological and Neurodegenerative Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acquired Brain Injuries
Spinal Cord Injury
Multiple Sclerosis
Parkinson Disease
Keywords: Neurorehabilitation
Virtual Reality
Cognitive and motor recovery
cognitive rehabilitation
neurological disorders
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Cognitive Function
timeFrame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
measure: Improvement in Motor Function
timeFrame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Secondary outcomes:
measure: Neurophysiological Changes Associated with Rehabilitation
timeFrame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
measure: Effectiveness of Telerehabilitation
timeFrame: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention)
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
state: Italy/Me
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
state: Italy/Me
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Maria Grazia Maggio, PhD, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: De 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.
citation: Maggio 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.