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Training Attention and Eye Movement in ASD

Wireless EEG System for Training Attention and Eye Movement in ASD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02403817
Enrollment
30
Registered
2015-03-31
Start date
2015-11-30
Completion date
2018-08-31
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Autistic Disorder

Keywords

Video Games

Brief summary

Current therapies for autism target social and language behaviors, but due to the high-level nature of these skills any improvement rarely extends beyond the targeted behavior. This project uses new technology to implement a novel concept for behavioral intervention to improve basic attention and eye movement skills in ASD. Because these basic skills form the foundation for good social communication, training these abilities has the potential to improve a broad spectrum of clinical symptoms, and in young children may affect the course of development.

Detailed description

Autism Spectrum Disorder (ASD) is a lifelong disorder that severely affects the ability to learn and function in a social environment. In typical function, higher level social, language and communication skills develop over the first few years of life and depend upon the critical building blocks of sensory-motor and attention abilities. Similarly in autism, higher level problems with social communication develop over the first two post-natal years and are preceded by subtle but abnormal visual attention and motor skills. Trainings to improve social interaction and communication are the most common of behavioral interventions in ASD. These therapies may improve the specific behaviors that are targets of the training, but rarely do they generalize to broader function or other clinical symptoms. The investigators propose that interventions aimed instead at the early deficits that support social and language skills would be more broadly effective. Because disruption of attention is one of the earliest and most persistent symptoms in autism, and because attention is highly subject to improvement with training, it is an important target for intervention. This a novel intervention to train the speed and accuracy of attention orienting and eye movement. The training is designed to target attentional behaviors that have been shown to be impaired in autism, including attention orienting, disengagement and shifting, and a restricted attentional field. Because eye movement and attention are tightly linked, eye movement deficits in ASD parallel those found in spatial attention. Eye movements provide a marker for attention and the proposed training is designed to improve speed, accuracy and flexibility of eye movement and attention simultaneously. Training uses a series of entertaining video games to gradually shape behavior using visual and auditory feedback provided in real time. The investigators plan three levels of outcome measures for pre- and post-training to test the effectiveness of the intervention (direct tests of attention and eye movement; tests of improvement in attentional and visual monitoring and speed and accuracy of response in a simulated environment; tests of behavior in an actual social environment). The investigators will conduct clinical trials with control conditions (e.g., standard video games without training elements) with a small sample of ASD children aged 9-15. If this initial work is successful, the long term goal is to develop a readily available inexpensive eyetracker-based system for home use that is suitable for a broad age range of ASD children and adults.

Interventions

BEHAVIORALCognitive Training

A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.

BEHAVIORALEye Motor Training

Game play will be controlled by the player's eye movements (via an eye tracking device)

BEHAVIORALHand Motor Training

Game play will be controlled by the player's hand movements (via a joystick).

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This project develops the intervention and includes a small clinical (behavioral) trial for ASD participants. A small number of ASD participants will be randomly assigned to intervention 'games' played by mouse response--the others to gaze-driven response.

Eligibility

Sex/Gender
ALL
Age
9 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Participant has a diagnosis of Autism Spectrum Disorder (on Diagnostic and Statistical Manual -IV, Autism Diagnostic Observation Schedule, Autism Diagnostic Interview-Revised) * Participant has a nonverbal Intelligence Quotient (IQ) of 85 or greater and verbal IQ of 70 or greater * Cooperative and able to follow instructions * Normal hearing acuity * Normal or corrected-to-normal vision

Exclusion criteria

* Major medical or neurological problems including seizures, diagnosed epileptiform EEG abnormalities, migraine, tuberous sclerosis, fragile X, static encephalopathies resulting from prior Central Nervous System insults, significant premature birth, and history of exposure to teratogens, metabolic abnormalities, and history of head trauma, cerebral palsy, stroke, meningitis, brain tumor or additional psychiatric diagnoses * Participants currently participating in vision therapy will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Spatial Attention BaselinePre-interventionThis behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations.
Saccadic Eye Movements BaselinePre-interventionThis task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task.
Change in Spatial Attention at 8 Weeksend of Week 8This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention.
Change in Saccadic Eye Movements at 8 Weeksend of Week 8This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task.

Countries

United States

Participant flow

Participants by arm

ArmCount
Eye Movement Game Control
Cognitive Training Eye Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Eye Motor Training: Game play will be controlled by the player's eye movements (via an eye tracking device)
23
Hand Movement Game Control
Cognitive Training Hand Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Hand Motor Training: Game play will be controlled by the player's hand movements (via a joystick).
2
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject50

Baseline characteristics

CharacteristicEye Movement Game ControlHand Movement Game ControlTotal
Age, Continuous17.31 years
STANDARD_DEVIATION 4.3
21.41 years
STANDARD_DEVIATION 0.4
17.62 years
STANDARD_DEVIATION 4.3
Autism Diagnosis23 Participants2 Participants25 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants0 Participants4 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
7 Participants0 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants2 Participants14 Participants
Region of Enrollment
United States
23 participants2 participants25 participants
Sex: Female, Male
Female
5 Participants0 Participants5 Participants
Sex: Female, Male
Male
18 Participants2 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 2
other
Total, other adverse events
0 / 280 / 2
serious
Total, serious adverse events
0 / 280 / 2

Outcome results

Primary

Change in Saccadic Eye Movements at 8 Weeks

This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task.

Time frame: end of Week 8

Population: Because of technical difficulties we have data for only part of the sample.

ArmMeasureValue (MEAN)Dispersion
Eye Movement Game ControlChange in Saccadic Eye Movements at 8 Weeks59.4 Percent Correct DirectionStandard Deviation 2.7
Comparison: This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).p-value: 0.018t-test, 2 sided
Primary

Change in Spatial Attention at 8 Weeks

This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention.

Time frame: end of Week 8

Population: All participants who completed 8 weeks of training were analyzed.

ArmMeasureValue (MEAN)Dispersion
Eye Movement Game ControlChange in Spatial Attention at 8 Weeks88.07 Percent CorrectStandard Deviation 13.9
Hand Movement Game ControlChange in Spatial Attention at 8 Weeks77.5 Percent CorrectStandard Deviation 16.3
Comparison: This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).p-value: 0.00005t-test, 2 sided
Primary

Saccadic Eye Movements Baseline

This task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task.

Time frame: Pre-intervention

Population: Because of technical difficulties we have only partial data for this measure.

ArmMeasureValue (MEAN)Dispersion
Eye Movement Game ControlSaccadic Eye Movements Baseline49.20 percent correct directionStandard Deviation 2.8
Primary

Spatial Attention Baseline

This behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations.

Time frame: Pre-intervention

Population: All participants who completed the 8 weeks of game-based training were analyzed.

ArmMeasureValue (MEAN)Dispersion
Eye Movement Game ControlSpatial Attention Baseline80.3 Percent CorrectStandard Deviation 14.8
Hand Movement Game ControlSpatial Attention Baseline43.0 Percent CorrectStandard Deviation 26.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026