Gaze-Controlled Computer Game for Neurodevelopmental Disorders

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Cognitive medications

Disqualifiers: Sensory impairment, Head trauma, Seizures

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a computer game controlled by eye movements. The game aims to improve attention and brain response in individuals with neurodevelopmental disorders. Researchers will monitor participants' eye movements and brain activity during gameplay. The trial seeks participants who can engage in experiments using eye-tracking and EEG (a test that measures brain activity) and who do not have sensory impairments or take certain medications. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in neurodevelopmental therapy.

Will I have to stop taking my current medications?

If you are taking prescription medications that may affect cognitive processes, you will not be able to participate in the trial.

What prior data suggests that this computer game is safe for participants?

Research shows limited specific safety information for gaze-controlled computer games. However, studies on similar games have generally assessed their practicality and safety. These games often aim to enhance skills like understanding eye contact, particularly for individuals with autism.

This trial involves playing a video game, differing from taking new medicine or undergoing a medical procedure, so the risks are typically lower. Similar studies have reported no serious issues, with participants generally finding the games easy to handle and safe.

Overall, while detailed safety information is lacking, the nature of the game suggests it poses a low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the gaze-controlled computer game because it offers a novel and engaging approach to helping individuals with neurodevelopmental disorders. Unlike traditional treatments, which might include behavioral therapy or medication, this game uses eye-tracking technology to create an interactive experience that can improve attention and cognitive skills. The game encourages active participation and can be tailored to individual needs, making it a flexible and personalized method that could enhance therapy outcomes. This innovative approach could provide a non-invasive and fun alternative to existing treatment options.

What evidence suggests that this computer game is effective for neurodevelopmental disorders?

Research has shown that serious games, such as the gaze-controlled computer game in this trial, can help manage behavior and cognitive issues in children with neurodevelopmental disorders. One study found that children who played an eye-controlled game improved their focus and response speed. Another study found that these games can help children understand eye contact and pay more attention to faces, which is particularly beneficial for those with autism. Adding game-like features, known as gamification, can also enhance engagement and effectiveness. Overall, early findings suggest that this game could improve both focus and brain response to various stimuli. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with neurodevelopmental disorders who can participate in eye-tracking and EEG experiments. It's not suitable for those with impairments that prevent protocol completion, those on cognition-affecting medications, or with a history of significant head trauma or seizures.

Inclusion Criteria

I can participate in an experiment that tracks my eye movements.

I can take part in an EEG test.

Exclusion Criteria

I have had a significant head injury or seizures in the past.

I am on medication that could affect my thinking or memory.

Sensory or physical impairment that would preclude completion of protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants play a computer game controlled by their gaze patterns to direct attention to on-screen targets

4-6 weeks

Follow-up

Participants are monitored for changes in visual attention and brain response after game play

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computer Game

Trial Overview

The study tests a computer game designed to enhance visual attention and brain response by rewarding players when they focus on specific targets. The game tracks gaze patterns and records both visual behavior and neural activity during play.

How Is the Trial Designed?

Group I: Game Experimental Treatment 1 Intervention

Participants will play a video game directing their gaze to on-screen targets.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Game-based digital therapeutics (DTx), like EndeavorRx®, significantly improved inattention and hyperactivity/impulsivity in children with ADHD compared to control groups, based on assessments from parents and teachers.

However, traditional medication was found to be more effective than game-based DTx in reducing inattention and hyperactivity/impulsivity, indicating that while DTx offers a beneficial alternative, it may not replace conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. Oh, S., Choi, J., Han, DH., et al.[2023]

A new automated gaming platform designed for children with autism focuses on improving key skills like Imitation and Joint Attention through engaging games, showing promise for intensive intervention in home settings.

In a 3-month trial with 10 children, parents reported improvements in their child's concentration (78%), flexibility (89%), and self-esteem (44%), indicating the platform's potential effectiveness in enhancing developmental skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Bono, V., Narzisi, A., Jouen, AL., et al.[2020]

Video game-based assessment tools have been found effective in distinguishing between children with ADHD and those without, as well as identifying different ADHD subtypes, based on a review of 22 studies.

Video game-based therapeutic interventions are generally well accepted and effective in improving cognitive functions and reducing ADHD symptoms, with gamification and cognitive training being key mechanisms of their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video games for the assessment and treatment of attention-deficit/hyperactivity disorder: a systematic review. Peñuelas-Calvo, I., Jiang-Lin, LK., Girela-Serrano, B., et al.[2022]

Active video gaming (AVG) shows potential for improving motor function in children with movement disorders, as evidenced by 20 studies that reported positive outcomes, although the improvements were not always significantly better than conventional therapy.

The studies varied widely in quality, sample sizes, and treatment individualization, highlighting the need for further research to establish effective dosing and to explore AVG as a supplementary treatment in home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of active video gaming in children with neuromotor dysfunction: a systematic review. Hickman, R., Popescu, L., Manzanares, R., et al.[2018]

In a study involving 19 children aged 10-12, playing real table tennis resulted in more precise and slower movements compared to playing on three different active virtual game consoles (Nintendo Wii, Xbox Kinect, Sony Move), indicating that virtual games may not effectively replicate real-world motor skills.

The differences in movement patterns between real and virtual table tennis suggest that current active virtual games may hinder the development of gross motor skills, highlighting the need for higher fidelity games that better mimic real-life activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the upper limb movement kinematics utilized by children playing virtual and real table tennis. Bufton, A., Campbell, A., Howie, E., et al.[2014]

Citations

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Serious Gaming and Eye-Tracking for the Screening, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6173230/

Improving sensitivity to eye gaze cues in autism using ...

We predict that the game will increase understanding of gaze cues and attention to faces. Methods and analysis. The Social Games for Adolescents ...

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(PDF) Gaze controlled games

This paper reviews past work on eye tracker gaming and charts future development possibilities in different sub-domains within.

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Gamification of eye-tracking procedures for cognitive diagnosis might increase engagement and help mitigate these problems, but its effects ...

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The investigators will test this hypothesis in a small-scale exploratory randomized control trial that will include both behavioral and eye tracking outcome ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0149763423001252

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A serious game-derived index for detecting children with heterogeneous developmental disabilities: randomized controlled trial. JMIR Serious Games, 7 (2019) ...