Attention Deficit Hyperactivity Disorder (ADHD)NCT07426289
Virtual Reality Supported Rehabilitation for Children's Executive and Metaphonological Skills
A study testing vrrs and Treatment as usual in people with Attention Deficit Hyperactivity Disorder (ADHD), run by IRCCS Centro Neurolesi Bonino Pulejo.
Trial summary
Executive functions and metaphonological skills are closely interconnected in supporting language development and learning processes.Investigating this relationship could offer new insights into how executive and metaphonological skills interact, supporting the development of integrated intervention strategies… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- vrrs and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Dec 2030
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 8 to 12 years
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- Attending 3rd, 4th, or 5th grade of primary school
- IQ greater than 70 (based on recent cognitive assessment)
- Presence of executive function impairment and/or metaphonological difficulties
- Availability of a baseline neuropsychological assessment (T0) completed within the last 3 months
- Parental consent obtained
Who cannot join
- Comorbid diagnosis of specific learning disorders (SLD)
- Neurological, genetic, or psychiatric comorbidities other than ADHD
- Uncorrected sensory impairments (vision or hearing)
- Lack of informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Effectiveness of a Virtual Reality Rehabilitation System (VRRS) Intervention on Executive Function Enhancement and Monitoring of Metaphonological Skills in ADHD Children
Executive functions and metaphonological skills are closely interconnected in supporting language development and learning processes.Investigating this relationship could offer new insights into how executive and metaphonological skills interact, supporting the development of integrated intervention strategies targeting both cognitive and linguistic domains.
This study aims to evaluate the effectiveness of a rehabilitation intervention using a virtual reality system (VRRS) in enhancing executive functions and monitoring metaphonological skills in children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD).The aim is to explore whether a semi-immersive digital cognitive training protocol can lead to measurable improvements in executive functions, and whether such improvements are associated with gains in metaphonological skills.
Participants will present deficits in executive functions and metaphonological skills and will undergo pre- and post-intervention assessments. These assessments include standardized neuropsychological and speech-language pathology tools designed to detect impairments in attention, inhibition, working memory, phonological awareness, and behavior in home and school settings.
- Being tested
- vrrs, Treatment as usual
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vrrsBehavioural
The intervention consists of 12 individual sessions using the Virtual Reality Rehabilitation System (VRRS).Each session lasts 45 minutes and is conducted twice a week over a 6-week period. The protocol is designed to stimulate and enhance executive functions such as working memory, inhibition, planning, and attention shifting in ADHD children.
The VRRS platform integrates semi-immersive, interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.
Treatment as usualBehavioural
Participants will begin the Traditional CBT intervention without the use of virtual reality technology
| Study group | Role | What they receive |
|---|---|---|
| VRRS Intervention | Experimental | Not described Receives: Behavioral: vrrs |
| control group | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nepsy
NEPSY-II
Measured: 6 weeks
tower of london
Measured: 6 weeks
CMF - Italian Assessment Battery for Metaphonological Skills
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start31 Mar 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completion31 Dec 2030 (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 Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PICCOLO, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy 98100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426289
- Sponsor's protocol ID
- vrrs25
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shokrkon A, Nicoladis E. The Directionality of the Relationship Between Executive Functions and Language Skills: A Literature Review. Front Psychol. 2022 Jul 19;13:848696. doi: 10.3389/fpsyg.2022.848696. eCollection 2022.
PubMed 35928417Menezes A, Dias NM, Trevisan BT, Carreiro LR, Seabra AG. Intervention for executive functions in attention deficit and hyperactivity disorder. Arq Neuropsiquiatr. 2015 Mar;73(3):227-36. doi: 10.1590/0004-282X20140225.
PubMed 25807129Corrigan N, Pasarelu CR, Voinescu A. Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. Virtual Real. 2023 Feb 18:1-20. doi: 10.1007/s10055-023-00768-1. Online ahead of print.
PubMed 36845650
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Virtual Reality Rehabilitation System (VRRS) Intervention on Executive Function Enhancement and Monitoring of Metaphonological Skills in ADHD Children
- ClinicalTrials.gov ID
- NCT07426289
- Acronym / sponsor ID
- vrrs25
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Feb 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.
Executive functions and metaphonological skills are closely interconnected in supporting language development and learning processes.Investigating this relationship could offer new insights into how executive and metaphonological skills interact, supporting the development of integrated intervention strategies targeting both cognitive and linguistic domains.
This study aims to evaluate the effectiveness of a rehabilitation intervention using a virtual reality system (VRRS) in enhancing executive functions and monitoring metaphonological skills in children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD).The aim is to explore whether a semi-immersive digital cognitive training protocol can lead to measurable improvements in executive functions, and whether such improvements are associated with gains in metaphonological skills.
Participants will present deficits in executive functions and metaphonological skills and will undergo pre- and post-intervention assessments. These assessments include standardized neuropsychological and speech-language pathology tools designed to detect impairments in attention, inhibition, working memory, phonological awareness, and behavior in home and school settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRRS Intervention | Experimental | Behavioral: vrrs |
| control group | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children aged 8 to 12 years
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- Attending 3rd, 4th, or 5th grade of primary school
- IQ greater than 70 (based on recent cognitive assessment)
- Presence of executive function impairment and/or metaphonological difficulties
Key exclusion criteria (4 listed)
- Comorbid diagnosis of specific learning disorders (SLD)
- Neurological, genetic, or psychiatric comorbidities other than ADHD
- Uncorrected sensory impairments (vision or hearing)
- Lack of informed consent
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 |
|---|---|---|
| vrrsThe intervention consists of 12 individual sessions using the Virtual Reality Rehabilitation System (VRRS).Each session lasts 45 minutes and is conducted twice a week over a 6-week period. The protocol is designed to stimulate and enhance executive functions such as working memory, inhibition, planning, and attention shifting in ADHD children. The VRRS platform integrates semi-immersive, interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance. | Behavioural | VRRS Intervention |
| Treatment as usualParticipants will begin the Traditional CBT intervention without the use of virtual reality technology | Behavioural | control group |
Primary outcome
Nepsy
Time frame: 6 weeks
NEPSY-II
tower of london
Time frame: 6 weeks
CMF - Italian Assessment Battery for Metaphonological Skills
Time frame: 6 weeks
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 23 Feb 2026.
- Results publication: PubMed 35928417Shokrkon A, Nicoladis E. The Directionality of the Relationship Between Executive Functions and Language Skills: A Literature Review. Front Psychol. 2022 Jul 19;13:848696. doi: 10.3389/fpsyg.2022.848696. eCollection 2022.
- Results publication: PubMed 25807129Menezes A, Dias NM, Trevisan BT, Carreiro LR, Seabra AG. Intervention for executive functions in attention deficit and hyperactivity disorder. Arq Neuropsiquiatr. 2015 Mar;73(3):227-36. doi: 10.1590/0004-282X20140225.
- Results publication: PubMed 36845650Corrigan N, Pasarelu CR, Voinescu A. Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. Virtual Real. 2023 Feb 18:1-20. doi: 10.1007/s10055-023-00768-1. Online ahead of print.
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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.
PICCOLO principal investigator
IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy 98100
Questions about this trial
What is this clinical trial studying?
A study testing vrrs and Treatment as usual in people with Attention Deficit Hyperactivity Disorder (ADHD), run by IRCCS Centro Neurolesi Bonino Pulejo.
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 7 inclusion and 4 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Adriana Piccolo, PSY (+3909060128256, info@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nepsy (time frame: 6 weeks). The study lists 3 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 NCT07426289, 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 23 Feb 2026.