NCT07341204

Brief Summary

The goal of this study is to determine whether playing a virtual reality (VR) game can help neurodivergent children pay attention for extended periods. The study includes children ages 9 to 18 who have autism, ADHD, learning differences, or movement coordination challenges. The program lasts for 6 weeks. During this period, children will play a VR game twice per week, with each session lasting 25 minutes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Keywords

attentionimpulsivitydistractabilityfocusVRImmersive Virtual Reality

Outcome Measures

Primary Outcomes (2)

  • RightEye Assessment:

    The RightEye system uses an infrared camera-based sensor bar attached to a monitor to objectively measure and analyze eye movements in real-time. It quantifies changes in attention-related oculomotor functions, including saccadic accuracy, smooth pursuit, reaction time, distractibility, and sustained attention. These metrics provide objective biomarkers for inattention and impulsivity, supporting occupational therapy goals of enhancing visual-motor integration, executive function, and participation in daily activities like reading or classroom engagement.

    Individual tests: 60 seconds (e.g., saccades) to 4-5 minutes (e.g., reaction time or pursuit tasks). Total session: 15-20 minutes, including 1-2 minutes for 9-point calibration and setup.

  • Test of Variables of Attention (TOVA)

    The TOVA objectively measures sustained attention and inhibitory control via responses to visual stimuli (targets vs. non-targets). In this study, the visual TOVA will assess pre- and post-VR changes in attention in children with neurodevelopmental conditions, targeting omission errors, commission errors, response time, and response time variability.

    Standard visual test: 21.6 minutes (4 quarters of 5.4 minutes). Full session: 30-45 minutes (setup/review); short form for younger children (10.8 minutes; used for ages 9+).

Study Arms (1)

Does participation in a 6-week VR-based program improve attentional skills in neurodiverse children?

EXPERIMENTAL

The research design comprises a nonequivalent quasi-experimental, multi-group pre- and post-test design (neurodivergent and neurotypical). The pre-test and post-test will consist of the Test of Variables of Attention (TOVA) and the RightEye assessment. These measures will be administered at the clinical site (ISF). The intervention consists of two 25-minute VR sessions per week for 6 weeks.

Behavioral: Virtual Reality

Interventions

Virtual RealityBEHAVIORAL

Participants will engage in an immersive virtual reality (VR) game intervention designed to improve visual attention skills. The intervention employs a VR game called Electrical Maze, which requires players to maintain sustained visual attention and respond to game challenges that develop focus and inhibitory control. Each participant will complete scheduled VR gaming sessions that target attentional skill development. During the sessions, children interact with the Electrical Maze game, which presents visual tasks that require them to identify and respond to specific visual cues while inhibiting responses to non-target stimuli.

Does participation in a 6-week VR-based program improve attentional skills in neurodiverse children?

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of ASD, ADHD, SLD, or DCD confirmed by a licensed clinician or documented in medical/educational records (DSM-5 or equivalent).
  • Parent/guardian consent and participant assent (age-appropriate).
  • Ability to follow simple verbal instructions and to participate in 25-minute VR sessions twice weekly for 6 weeks.
  • Stable medication regimen for attention- or behavior-related medications for ≥4 weeks prior to baseline (or not taking such medications).
  • Visual and auditory ability adequate for VR tasks (with or without usual corrective lenses/hearing aids).
  • Availability to attend all scheduled sessions at the clinical site across the 6-week period.

You may not qualify if:

  • History of photosensitive epilepsy or any uncontrolled seizure disorder.
  • Severe intellectual disability or severe communication impairment that prevents understanding/participation (e.g., non-responsive to simple commands required by the VR tasks).
  • Severe visual, auditory, or motor impairment that prevents safe or functional use of the VR system (e.g., inability to hold controllers or view the headset even with correction).
  • Recent (within 6 months) significant brain injury or neurosurgery. Significant history of motion sickness, severe vestibular disorder, or prior intolerance to immersive VR.
  • Any medical or implanted device contraindicated for VR/headset use (if applicable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inclusive Sports and Fitness, Inc.

Old Westbury, New York, 11568-8000, United States

Location

MeSH Terms

Conditions

Autistic DisorderAttention Deficit Disorder with HyperactivityImpulsive Behavior

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersBehavior

Central Study Contacts

Alexander Lopez, JD, OT/L

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The purpose of this study is to determine the impact of the VR game (Electrical Maze) on sustained attention outcomes in children with Neurodivergent conditions (ASD, ADHD, SLD, and DCD). The usage of an active intervention classifies this study as an interventional design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

February 2, 2026

Primary Completion

March 27, 2026

Study Completion

April 6, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations