Training Attention and Eye Movement in ASD

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT02403817
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder; Autism Spectrum Disorder	Behavioral: Cognitive Training; Behavioral: Eye Motor Training; Behavioral: Hand Motor Training	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: Wireless EEG System for Training Attention and Eye Movement in ASD
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eye Movement Game Control Cognitive Training Eye Motor Training	Behavioral: 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.; Behavioral: Eye Motor Training; Game play will be controlled by the player's eye movements (via an eye tracking device)
Active Comparator: Hand Movement Game Control Cognitive Training Hand Motor Training	Behavioral: 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.; Behavioral: Hand Motor Training; Game play will be controlled by the player's hand movements (via a joystick).

Outcome Measures

Primary Outcome Measures

1. Spatial Attention Baseline [Pre-intervention]

   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.

2. Saccadic Eye Movements Baseline [Pre-intervention]

   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.

3. Change in Spatial Attention at 8 Weeks [end of Week 8]

   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.

4. Change in Saccadic Eye Movements at 8 Weeks [end of Week 8]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	La Jolla	California	United States	92093-0959

Sponsors and Collaborators

• University of California, San Diego

Investigators

• Principal Investigator: Jeanne Townsend, Ph.D., University of California, San Diego

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 8, 2019

More Information

Publications

None provided.

• Responsible Party: Jeanne Townsend, PhD, Professor of Neurosciences, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02403817
• Other Study ID Numbers: R33MH096967
• First Posted: Mar 31, 2015
• Last Update Posted: Dec 4, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeanne Townsend, PhD, Professor of Neurosciences, University of California, San Diego: Video Games
• Additional relevant MeSH terms: Disease; Autism Spectrum Disorder; Autistic Disorder

Study Results

Participant Flow

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)	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: Gameplay will be controlled by the player's hand movements (via a joystick).
Period Title: Overall Study
STARTED	28	2
COMPLETED	23	2
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control	Total
Arm/Group Description	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)	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).	Total of all reporting groups
Overall Participants	23	2	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.31 (4.3)	21.41 (.4)	17.62 (4.3)
Sex: Female, Male (Count of Participants)
Female	5 21.7%	0 0%	5 20%
Male	18 78.3%	2 100%	20 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 17.4%	0 0%	4 16%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 52.2%	2 100%	14 56%
More than one race	7 30.4%	0 0%	7 28%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	23 100%	2 100%	25 100%
Autism Diagnosis (Count of Participants)
Count of Participants [Participants]	23 100%	2 100%	25 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)	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: Gameplay will be controlled by the player's hand movements (via a joystick).
Measure Participants	23	2
Mean (Standard Deviation) [Percent Correct]	80.3 (14.8)	43.0 (26.9)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)	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: Gameplay will be controlled by the player's hand movements (via a joystick).
Measure Participants	16	0
Mean (Standard Deviation) [percent correct direction]	49.20 (2.8)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who completed 8 weeks of training were analyzed.

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)	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: Gameplay will be controlled by the player's hand movements (via a joystick).
Measure Participants	23	2
Mean (Standard Deviation) [Percent Correct]	88.07 (13.9)	77.5 (16.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Eye Movement Game Control
	Comments	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).
	Type of Statistical Test	Other
	Comments	This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).
Statistical Test of Hypothesis	p-Value	0.00005
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eye Movement Game Control	Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)	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: Gameplay will be controlled by the player's hand movements (via a joystick).
Measure Participants	16	0
Mean (Standard Deviation) [Percent Correct Direction]	59.4 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Eye Movement Game Control
	Comments	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).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	For each subject, data were collected from initial enrollment for 8 weeks.
Adverse Event Reporting Description	Definition not different.
Arm/Group Title	Eye Movement Game Control		Hand Movement Game Control
Arm/Group Description	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: Gameplay will be controlled by the player's eye movements (via an eye tracking device)		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: Gameplay will be controlled by the player's hand movements (via a joystick).
All Cause Mortality
	Eye Movement Game Control		Hand Movement Game Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/2 (0%)
Serious Adverse Events
	Eye Movement Game Control		Hand Movement Game Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Eye Movement Game Control		Hand Movement Game Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.