Gaze-Controlled Computer Game for Neurodevelopmental Disorders

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will play a computer game that is controlled by their gaze patterns and designed to direct attention their attention to specific on-screen targets. Visual attention to targets will be rewarded. Both visual behavior and brain response will be recorded during game play. It is hypothesized that that, over the course of the game, relative to baseline, participants will show (a) increased looking to targets, (b) decreased response time to targets, and (c) enhanced, more efficient neural response to visual cues. It is hypothesized that clinical variability will associate with visual attention and brain response.

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 data supports the effectiveness of the treatment Computer Game for neurodevelopmental disorders?

Research shows that serious games, which are interactive video games, can help manage behavioral and cognitive issues in children with neurodevelopmental disorders. A study on a gaming platform for children with autism found improvements in concentration, flexibility, and self-esteem, suggesting that similar game-based interventions could be beneficial. ^{1 2 3 4 5}

Is the gaze-controlled computer game generally safe for humans?

The research on game-based digital therapeutics, like EndeavorRx®, which is FDA-approved for ADHD, suggests that these types of games are generally safe for children and adolescents. However, specific safety data for gaze-controlled games is not detailed in the available studies. ^{1 6 7 8 9}

How does the gaze-controlled computer game treatment differ from other treatments for neurodevelopmental disorders?

The gaze-controlled computer game is unique because it uses eye-tracking technology to help improve attention and eye movement control in children with neurodevelopmental disorders, offering a low-cost, engaging, and home-based training option that targets early deficits in gaze and attention. ^{1 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Serious Games in the new era of digital-health interventions: A narrative review of their therapeutic applications to manage neurobehavior in neurodevelopmental disorders. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Feasibility Study of a Gamified Therapy Prescription App for Children with Neurodisability. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A systematic review evaluating the implementation of technologies to assess, monitor and treat neurodevelopmental disorders: A map of the current evidence. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Video games for the assessment and treatment of attention-deficit/hyperactivity disorder: a systematic review. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

[A comparative study of recreational screen time in neurodevelopmental disorders]. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Use of active video gaming in children with neuromotor dysfunction: a systematic review. [2018]

8. Germany 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. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of the upper limb movement kinematics utilized by children playing virtual and real table tennis. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Design of an Interactive Virtual Reality System, InViRS, for Joint Attention Practice in Autistic Children. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A novel approach to training attention and gaze in ASD: A feasibility and efficacy pilot study. [2019]

13. England pubmed.ncbi.nlm.nih.gov

A tablet-based game for the assessment of visual motor skills in autistic children. [2023]