AutismNCT07643649
Cognitive Training in Virtual Reality for Autism
A study testing Experimental Group in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Experimental Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Mar 2027
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autism
- QI > 70
Who cannot join
- Severe neurological or sensory comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Valeria Maiorana contact
Italy1 site
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Ileana Scarcella, 3408322948 ext. +39, Ileana.scarcella@irib.cnr.it
Flavia Marino
About this study
Official title: Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism
The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.
This randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ >70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.
It is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Experimental Group, Control Group
- Keywords
- autism, children, Virtual Reality Rehabilitation System, Cognitive Training, Executive Functions, Visual Attention, Visuo-Spatial Memory, Autism Spectrum Disorder, Autism Spectrum Condition
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupDevice
During every single session, each participant will engage in the selected tasks for approximately five minutes per exercise through the use of VRRS, in order to specifically stimulate the different target cognitive functions (visual attention, executive functions, and visuo-spatial memory)
Control GroupOther
During every single session, each participant will engage in the selected tasks with objectives equivalent to those of the experimental group, but without the use of virtual reality, instead employing traditional methods and paper-and-pencil activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group with VRRS | Experimental | Fifteen children with a diagnosis of autism spectrum disorder will undergo training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of the Virtual Reality Rehabilitation System (VRRS). Receives: Device: Experimental Group |
| Control Group without VRRS | Other | Fifteen children with a diagnosis of autism spectrum disorder will undergo traditional training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of paper-pencil tools and cognitive tasks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leiter International Performance Scale, Third Edition (LEITER 3)
The LEITER-3 is a completely nonverbal test designed to measure IQ and cognitive skills, suitable for children, adolescents and adults aged 3 to 80 years. It includes ten subtests divided into two batteries: the Cognitive Battery and the Attention and Memory Battery. The Cognitive Battery asses intellectual domains, such as reasoning, visualization, and problem-solving, trough following subtests: Form Completion (FC), Classification/Analogies (CA), Sequential Order (SO), and Visual Patterns (VP). The Attention and Memory Battery evaluates attention, memory and other executive functions trough the following tasks: Sustained Attention (SA), Forward Memory (FM), Divided Attention (DA), Reverse Memory (RM), and Nonverbal Stroop (NS).
Scores from the Cognitive Battery subtests are combined to provide an overall index of nonverbal intelligence, while the Attention and Memory Battery allows identification of specific cognitive strengths and weaknesses.
Measured: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 20-45 minutes to complete.
Preschool Executive Functions Assessment Battery (FE-PS 2-6)
The FE PS 2-6 is a tool used to assess executive functions in preschool-aged children (2-6 years). It is a battery of 10 subtests, organized into three functional areas: Inhibitory Processes, Delay of Gratification and Complex and Interdependent Abilities such as inhibition, working memory and emerging cognitive flexibility. For each subtest, z-scores and percentiles will be calculated based on the raw score.
Measured: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 30-45 minutes to complete.
Developmental Neuropsychological Assessment - Second Edition (NEPSY-II)
The NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age. Only the Designed Memory subtest will be administered. This subtest assesses visuospatial learning ad memory abilities. The child is presented with a grid containing 4 to 10 designees per page, which is subsequently removed from view. The child is then required to select the corresponding designs from a set of cards and place them on the grid in the same spatial locations as previously presented. Memory for visual stimuli and memory for spatial location are scored and analyzed separately.
Measured: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 5-10 minutes to complete.
Behavior rating inventory of executive function-preschool version (BRIEF-P)
The BRIEF-P is a set of questionnaires for parents and teachers designed to evaluate executive function, for preschool children. It consists of 63 items that measure key domains of executive functioning: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize. The clinical scales are aggregated into three broader indices (Inhibitory Self-Control, Flexibility, and Emergent Metacognition) and one composite score (Global Executive Composite). Additionally, The BRIEF-P includes two validity scales (Inconsistency and Negativity), to ensure the realiability of the responses.
Measured: The evaluation sessions will be scheduled pre/post intervention (T0-T1). The test needs approximately 20 minutes to administer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643649
- Sponsor's protocol ID
- CNR-IRIB-PRO-2026-003
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cappadona I, Ielo A, La Fauci M, Tresoldi M, Settimo C, De Cola MC, Muratore R, De Domenico C, Di Cara M, Corallo F, Tripodi E, Impallomeni C, Quartarone A, Cucinotta F. Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial. Children (Basel). 2023 Aug 1;10(8):1336. doi: 10.3390/children10081336.
PubMed 37628335Maggio MG, Bonanno L, Rizzo A, Barbera M, Benenati A, Impellizzeri F, Corallo F, De Luca R, Quartarone A, Calabro RS. The role of virtual reality-based cognitive training in enhancing motivation and cognitive functions in individuals with chronic stroke. Sci Rep. 2025 Jul 12;15(1):25258. doi: 10.1038/s41598-025-08173-1.
PubMed 40652006Maresca G, Leonardi S, De Cola MC, Giliberto S, Di Cara M, Corallo F, Quartarone A, Pidala A. Use of Virtual Reality in Children with Dyslexia. Children (Basel). 2022 Oct 25;9(11):1621. doi: 10.3390/children9111621.
PubMed 36360349Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.
PubMed 34923256
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism
- ClinicalTrials.gov ID
- NCT07643649
- Acronym / sponsor ID
- CNR-IRIB-PRO-2026-003
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, children, Virtual Reality Rehabilitation System, Cognitive Training, Executive Functions, Visual Attention, Visuo-Spatial Memory, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.
This randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ >70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.
It is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group with VRRS | Experimental | Device: Experimental GroupFifteen children with a diagnosis of autism spectrum disorder will undergo training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of the Virtual Reality Rehabilitation System (VRRS). |
| Control Group without VRRS | Other | Other: Control GroupFifteen children with a diagnosis of autism spectrum disorder will undergo traditional training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of paper-pencil tools and cognitive tasks. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of Autism
- QI > 70
Key exclusion criteria (1 listed)
- Severe neurological or sensory comorbidities
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 |
|---|---|---|
| Experimental GroupDuring every single session, each participant will engage in the selected tasks for approximately five minutes per exercise through the use of VRRS, in order to specifically stimulate the different target cognitive functions (visual attention, executive functions, and visuo-spatial memory) | Device | Experimental Group with VRRS |
| Control GroupDuring every single session, each participant will engage in the selected tasks with objectives equivalent to those of the experimental group, but without the use of virtual reality, instead employing traditional methods and paper-and-pencil activities. | Other | Control Group without VRRS |
Primary outcome
Leiter International Performance Scale, Third Edition (LEITER 3)
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 20-45 minutes to complete.
The LEITER-3 is a completely nonverbal test designed to measure IQ and cognitive skills, suitable for children, adolescents and adults aged 3 to 80 years. It includes ten subtests divided into two batteries: the Cognitive Battery and the Attention and Memory Battery. The Cognitive Battery asses intellectual domains, such as reasoning, visualization, and problem-solving, trough following subtests: Form Completion (FC), Classification/Analogies (CA), Sequential Order (SO), and Visual Patterns (VP). The Attention and Memory Battery evaluates attention, memory and other executive functions trough the following tasks: Sustained Attention (SA), Forward Memory (FM), Divided Attention (DA), Reverse Memory (RM), and Nonverbal Stroop (NS). Scores from the Cognitive Battery subtests are combined to provide an overall index of nonverbal intelligence, while the Attention and Memory Battery allows identification of specific cognitive strengths and weaknesses.
Preschool Executive Functions Assessment Battery (FE-PS 2-6)
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 30-45 minutes to complete.
The FE PS 2-6 is a tool used to assess executive functions in preschool-aged children (2-6 years). It is a battery of 10 subtests, organized into three functional areas: Inhibitory Processes, Delay of Gratification and Complex and Interdependent Abilities such as inhibition, working memory and emerging cognitive flexibility. For each subtest, z-scores and percentiles will be calculated based on the raw score.
Developmental Neuropsychological Assessment - Second Edition (NEPSY-II)
Time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 5-10 minutes to complete.
The NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age. Only the Designed Memory subtest will be administered. This subtest assesses visuospatial learning ad memory abilities. The child is presented with a grid containing 4 to 10 designees per page, which is subsequently removed from view. The child is then required to select the corresponding designs from a set of cards and place them on the grid in the same spatial locations as previously presented. Memory for visual stimuli and memory for spatial location are scored and analyzed separately.
Behavior rating inventory of executive function-preschool version (BRIEF-P)
Time frame: The evaluation sessions will be scheduled pre/post intervention (T0-T1). The test needs approximately 20 minutes to administer.
The BRIEF-P is a set of questionnaires for parents and teachers designed to evaluate executive function, for preschool children. It consists of 63 items that measure key domains of executive functioning: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize. The clinical scales are aggregated into three broader indices (Inhibitory Self-Control, Flexibility, and Emergent Metacognition) and one composite score (Global Executive Composite). Additionally, The BRIEF-P includes two validity scales (Inconsistency and Negativity), to ensure the realiability of the responses.
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 11 Jun 2026.
- Background: PubMed 37628335Cappadona I, Ielo A, La Fauci M, Tresoldi M, Settimo C, De Cola MC, Muratore R, De Domenico C, Di Cara M, Corallo F, Tripodi E, Impallomeni C, Quartarone A, Cucinotta F. Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial. Children (Basel). 2023 Aug 1;10(8):1336. doi: 10.3390/children10081336.
- Background: PubMed 40652006Maggio MG, Bonanno L, Rizzo A, Barbera M, Benenati A, Impellizzeri F, Corallo F, De Luca R, Quartarone A, Calabro RS. The role of virtual reality-based cognitive training in enhancing motivation and cognitive functions in individuals with chronic stroke. Sci Rep. 2025 Jul 12;15(1):25258. doi: 10.1038/s41598-025-08173-1.
- Background: PubMed 36360349Maresca G, Leonardi S, De Cola MC, Giliberto S, Di Cara M, Corallo F, Quartarone A, Pidala A. Use of Virtual Reality in Children with Dyslexia. Children (Basel). 2022 Oct 25;9(11):1621. doi: 10.3390/children9111621.
- Background: PubMed 34923256Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.
- Individual participant dataSharing planned: No
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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.
Maria Valeria Maiorana contact
Flavia Marino principal investigator
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Ileana Scarcella (3408322948 ext. +39, Ileana.scarcella@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leiter International Performance Scale, Third Edition (LEITER 3) (time frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 20-45 minutes to complete.). The study lists 4 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 NCT07643649, which also lists 4 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 11 Jun 2026.