Training Attention and Eye Movement in ASD
Primary Purpose
Autistic Disorder, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Eye Motor Training
Hand Motor Training
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring Video Games
Eligibility Criteria
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
Sites / Locations
- University of California San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eye Movement Game Control
Hand Movement Game Control
Arm Description
Cognitive Training Eye Motor Training
Cognitive Training Hand Motor Training
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02403817
First Posted
March 23, 2015
Last Updated
December 3, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02403817
Brief Title
Training Attention and Eye Movement in ASD
Official Title
Wireless EEG System for Training Attention and Eye Movement in ASD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Autism Spectrum Disorder
Keywords
Video Games
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eye Movement Game Control
Arm Type
Experimental
Arm Description
Cognitive Training Eye Motor Training
Arm Title
Hand Movement Game Control
Arm Type
Active Comparator
Arm Description
Cognitive Training Hand Motor Training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.
Intervention Type
Behavioral
Intervention Name(s)
Eye Motor Training
Intervention Description
Game play will be controlled by the player's eye movements (via an eye tracking device)
Intervention Type
Behavioral
Intervention Name(s)
Hand Motor Training
Intervention Description
Game play will be controlled by the player's hand movements (via a joystick).
Primary Outcome Measure Information:
Title
Spatial Attention Baseline
Description
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
Title
Saccadic Eye Movements Baseline
Description
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
Title
Change in Spatial Attention at 8 Weeks
Description
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
Title
Change in Saccadic Eye Movements at 8 Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Townsend, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0959
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD is being shared through National Institutes of Health (NIH) National Database for Autism Research (NDAR).
IPD Sharing Time Frame
Data are available to share now (August 8, 2019) and can remain available indefinitely or as long as the National Database for Autism Research is supported.
IPD Sharing Access Criteria
Data are shared through the National Database for Autism Research. Access is by registration and meeting eligibility requirements established by the National Institutes of Health for data sharing.
Learn more about this trial
Training Attention and Eye Movement in ASD
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