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Recruiting NCT06123741

NCT06123741 Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

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Clinical Trial Summary
NCT ID NCT06123741
Status Recruiting
Phase
Sponsor Merja Nikula
Condition Attention Deficit Hyperactivity Disorder
Study Type INTERVENTIONAL
Enrollment 88 participants
Start Date 2024-01-10
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 8 Years
Max Age 12 Years
Study Type INTERVENTIONAL
Interventions
Parental GuidanceVirtual Reality Game

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 88 participants in total. It began in 2024-01-10 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations. The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress. Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of ADHD (ICD-10 F90.0) and * Methylphenidate medication and * Age 8-12 years and * Finnish as a native language Exclusion Criteria: * Sensitivity to flashing light, * Epilepsy (ICD-10 G40), * Mental retardation (ICD-10 F70-F79), * Pervasive developmental disorders (ICD-10 F84), * Inflammatory diseases of the central nervous system (ICD-10 G00-G09), * Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5), * Traumatic brain injury ((ICD-10 S06), * Brain tumour, and * Multiple pregnancy

Contact & Investigator

Central Contact

Merja Nikula, M.Psych.

✉ merja.nikula@pohde.fi

📞 +3588315 5218

Principal Investigator

Johanna Uusimaa, MD, PhD

STUDY CHAIR

Oulu University Hospital

Frequently Asked Questions

Who can join the NCT06123741 clinical trial?

This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06123741 currently recruiting?

Yes, NCT06123741 is actively recruiting participants. Contact the research team at merja.nikula@pohde.fi for enrollment information.

Where is the NCT06123741 trial being conducted?

This trial is being conducted at Oulu, Finland.

Who is sponsoring the NCT06123741 clinical trial?

NCT06123741 is sponsored by Merja Nikula. The principal investigator is Johanna Uusimaa, MD, PhD at Oulu University Hospital. The trial plans to enroll 88 participants.

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