Clinical trial NCT02403817: Training Attention and Eye Movement in ASD
Official title: Wireless EEG System for Training Attention and Eye Movement in ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Autism Spectrum Disorder
Keywords: Video Games
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spatial Attention Baseline
timeFrame: Pre-intervention
measure: Saccadic Eye Movements Baseline
timeFrame: Pre-intervention
measure: Change in Spatial Attention at 8 Weeks
timeFrame: end of Week 8
measure: Change in Saccadic Eye Movements at 8 Weeks
timeFrame: end of Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jeanne Townsend, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: