Clinical Trials Logo

Clinical Trial Summary

Autism spectrum disorder (ASD) is one of the most common developmental disabilities and often people with ASD have sensory processing disorders. These sensory processing disorders are often associated with problem behaviors and, more recently, have been connected to anxiety disorders in people with ASD. While it has been suggested that sensory processing responses in ASD could be malleable, current treatment strategies for sensory processing disorders in ASD have inconsistent results or lack large-sample sized data. This investigation will explore changes in neurophysiological activity in people with ASD and neurotypical peers after they are exposed to an unpleasant visual stimulus through a virtual reality systematic desensitization protocol. 30 people with ASD and 30 neurotypical people between the ages 7 - 35 will be recruited. The study have, 1) a practice magnetic resonance imaging (MRI) visit with questionnaires, 2) a per-exposure MRI with structural and functional MRI collections, 3) a virtual reality systematic desensitization session where we will record the participant's physiological response using an Emotibit device, and 4) a post-exposure MRI session with structural and functional MRI collections. This investigation aims to quantify changes in neurophysiological responses in order to determine the effect of systematic desensitization.


Clinical Trial Description

Autism Spectrum Disorder (ASD) is one of the most common developmental disabilities, with an estimated 1 in 54 children receiving a diagnosis. The total economic burden of ASD in the United States is estimated to be $268 billion and will increase to $461 billion by 2025. People with ASD have deficiencies in social relationships and communications and an increased rate of anxiety disorders, with some estimates suggesting 84% of people with ASD have anxiety. This anxiety can lead to an individual with ASD to exhibit avoidant behavior, which can include exclusion from activities to escalated behaviors that could be self-injurious or harmful to others. These avoidant behaviors can make participation in activities of daily living challenging for people with ASD, as the avoidant behavior is often considered socially-unacceptable behavior. While there has been increasing interest in anxiety in ASD, there is still a major knowledge gap in understanding how sensory processing disorders play a role in anxiety and if this can be treated. Sensory Processing in ASD: Sensory processing disorders were added to ASD diagnosis in The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition in 2013. Since then, there has been little research into the role that sensory processing disorders plays in the anxiety of people with ASD. Functional magnetic resonance imaging (fMRI) studies have demonstrated that people with ASD have greater brain activity in relevant sensory areas, the amygdala, and the orbital frontal cortex when exposed to combinations of unpleasant auditory, tactile, or visual stimuli. Further, people with ASD have a reduced ability to habituate to the same unpleasant stimuli in the relevant sensory cortices and amygdala, differences in the changes of brain activity in the orbital-frontal cortex, and differences in functional connectivity between the amygdala and orbital-frontal cortex. These brain responses have also been connected with physiological responses in children with ASD, as those with greater skin conductivity having reduced neural response in the orbital-frontal cortex and heart rate being positively correlated with activity in the inferior and medial frontal gyrus. Even though the neurophysiological evidence supports sensory processing differences in ASD, current treatment strategies are sparse and the results are often inconsistent. The most successful paradigm is exposure therapy through systematic desensitization, which has been used in both ASD and people with anxiety. While multisensory integration skills may be malleable, it has been suggested that exposure therapy may not be an effective long-term strategy, as the clinical team cannot perform exposure to every stimulus in every environment. With this in mind, new therapeutic techniques need to be designed to enable personalization of exposure experiences. Virtual Reality for ASD: One emerging technique that could enable quick personalization of unpleasant stimulus and environments is virtual reality (VR). Therapeutic VR software has shown to be an effective platform for skill training, mainly focusing on behavioral skills in social or educational environments. Two investigations demonstrated changes in neural activity after participating in VR social cognition training. However, the effects of using VR as a sensory exposure platform on the physiological response to unpleasant stimuli has not been explored. Purpose The research objectives of this application are to quantify the neurophysiological changes that occur after participating in a virtual reality systematic desensitization protocol. The following aims will be achieved the top physiological recording devices for ASD to collect physiological responses, front-line virtual reality systems to provide automated desensitization exposure therapy, and University of Nebraska Medical Center's research MRI system. 30 people with ASD and 30 neurotypical peers will be recruited to utilize this software. This proposal will be the first step in developing evidence-based therapies aimed at addressing sensory processing differences in ASD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06247176
Study type Interventional
Source University of Nebraska
Contact James E Gehringer, PhD
Phone 402-559-2562
Email james.gehringer@unmc.edu
Status Recruiting
Phase N/A
Start date January 8, 2024
Completion date January 1, 2027

See also
  Status Clinical Trial Phase
Completed NCT05207956 - App for Strengthening Services In Specialized Therapeutic Support N/A
Completed NCT03286621 - Development of Eye-tracking Based Markers for Autism in Young Children
Completed NCT02608333 - Efficiency of Early Intervention for Autism Spectrum Disorder N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Active, not recruiting NCT06259539 - A YouTube Curriculum for Children With Autism and Obesity N/A
Active, not recruiting NCT06303791 - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT04772898 - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder N/A
Recruiting NCT04987541 - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder N/A
Completed NCT04308915 - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders N/A
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Completed NCT03693313 - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Recruiting NCT03812068 - Parent-mediated Developmental Behavioral Intervention N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT02299700 - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder N/A
Completed NCT03422016 - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Recruiting NCT05114538 - Improving the Part C Early Intervention Service Delivery System for Children With ASD N/A