Innovative Methodologies for Neuroplasticity in Developmental Age With the Use of Virtual Reality

Official title

M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo

Overview

Neurodevelopmental disorders, such as Cerebral Palsy (CP), Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), are complex conditions that affect various aspects of children's development. Despite advancements in treatments, conventional rehabilitative interventions tend to focus on specific aspects, often overlooking the holistic needs of the patient. Many of these interventions fail to engage children, who may feel uninvolved or demotivated. Innovative technologies, such as immersive virtual reality (IVR), offer a promising alternative to make rehabilitation more engaging and comprehensive. This study aims to evaluate the effects of IVR-based rehabilitation on children and adolescents with neurodevelopmental disorders, focusing on improvements in cognitive, motor, and social functions. We hypothesize that IVR will enhance social interaction, attention, motor skills, and overall quality of life. The study will include children and adolescents aged 8 to 18 years, diagnosed with ADHD, ASD, and cerebral palsy. The CAR-EN platform, which provides a highly customizable therapeutic environment, will be used. Assessments will measure cognitive, motor, and social skills before and after the intervention. We expect immersive virtual reality to lead to significant improvements in the participants' cognitive, motor, and social abilities. These findings could potentially contribute to a shift in therapeutic guidelines, offering more effective treatments for children with neurodevelopmental disorders.

Detailed description

This protocol was created to evaluate the effects of rehabilitation with IVR in subjects with neurodevelopmental disorders that profoundly impact their quality of life and that of their families: Cerebral Palsy (CP), Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD).

In the literature we find many studies and guidelines concerning the neuropsychological interventions envisaged for the pathologies that affect our protocol.

However, rehabilitation interventions in the developmental age often focus on a single clinical aspect, aiming to implement some deficient skills and losing sight of the global vision of the patient and his needs.

Furthermore, conventional rehabilitation methods do not always appear motivating for the minor, who is often forced to perform the tasks required in a non-participatory and active way.

In recent decades, scientific research has instead highlighted the effectiveness of therapeutic interventions with innovative technologies, demonstrating how these tools can make the rehabilitation process more engaging and stimulating, both for adults and minors.

In particular, the use of Immersive Virtual Reality (IVR) is configured as a promising frontier in neuropsychological rehabilitation, with the potential to significantly improve patients' quality of life and optimize clinical outcomes compared to traditional methods.

Interventions

• Behavioral CAREN therapy
  The experimental intervention uses the CAREN immersive virtual reality system, which integrates visual, auditory and tactile sensory stimuli, to stimulate cognitive, motor and social skills through interactive exercises. The system monitors progress in real time and reduces the stress associated with traditional therapies, offering an innovative and engaging therapy experience.
• Behavioral Conventional interventions
  \- Neuropsychomotricity for children with cerebral palsy, with the objectives of motor improvement, balance and coordination. - Cognitive-behavioral training for ADHD, focusing on attentional skills, planning and emotional self-regulation. - Cognitive-behavioral training for ASD, focusing on cognitive flexibility, impulse control and motor coordination.

Primary outcome measures

• Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Gross Motor Function Assessed by the Gross Motor Function Measure-66 (GMFM-66) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Muscle Spasticity Assessed by the Modified Ashworth Scale (MAS) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Balance Assessed by the Tinetti Assessment Tool - Balance Subscale [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Attention and Memory Assessed by the NEPSY-Second Edition (NEPSY-II) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Executive Function Assessed by the Tower of London Test [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Executive Function Assessed by the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Behavioral and Attention Symptoms Assessed by the Conners' Rating Scales - Third Edition (Conners 3) [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Behavioral and Emotional Problems Assessed by the Child Behavior Checklist (CBCL) - Parent Version [Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)]
• Motor Competence Assessed by the Movement Assessment Battery for Children - Second Edition (Movement ABC-2) [Time frame: T0 (Baseline), T1 (1 month), T2 (3 months), T3 (Follow-up at 3 months)]

Secondary outcome measures (2)

• System Usability Assessed by the System Usability Scale (SUS) [Time frame: Up to 7 months]
• Behavioral Safety Assessed by the Behavioral Safety Event Rating Scale (B-SERS) [Time frame: Up to 7 months]

Eligibility criteria

Inclusion criteria

• Children and adolescents aged 8 to 18 years
• Diagnosis of one of the following neurodevelopmental disorders:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Autism Spectrum Disorder (ASD)
• Cerebral Palsy (CP)
• Ability to understand and comply with instructions for the intervention
• Adequate cognitive, motor, and social skills to participate in the rehabilitation program
• Informed consent obtained from a parent or legal guardian

Exclusion criteria

• Children and adolescents younger than 8 or older than 18 years
• Severe cognitive impairments or intellectual disabilities that prevent participation in the rehabilitation program
• Diagnosis of conditions not related to the target neurodevelopmental disorders, such as:

• Major psychiatric disorders (e.g., severe depression, schizophrenia)
• Neurological disorders not included in the study (e.g., epilepsy)
• Severe motor impairments that prevent interaction with the virtual reality platform
• Uncontrolled medical conditions (e.g., severe cardiovascular, respiratory, or endocrine diseases)
• Lack of informed consent from a parent or legal guardian
• Participation in another intervention or study that may interfere with the rehabilitation program
• Behavioral issues or extreme anxiety that make it impossible to follow instructions or interact with the virtual reality system

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Neurolesi Bonino Pulejo — Messina

Publications

• Calabro RS, Naro A, Cimino V, Buda A, Paladina G, Di Lorenzo G, Manuli A, Milardi D, Bramanti P, Bramanti A. Improving motor performance in Parkinson's disease: a preliminary study on the promising use of the computer assisted virtual reality environment (CAREN). Neurol Sci. 2020 Apr;41(4):933-941. doi: 10.1007/s10072-019-04194-7. Epub 2019 Dec 19. PMID 31858331

Identifiers

NCT: NCT07426315 · MINERVA_25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗