Sensory Habituation in Autism Spectrum Disorders

NCT06247176 | Terminated DMC

• 1 other identifier: 0709-22-EP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Autism; Sensory Processing Disorder; Sensory Over-Responsivity

Keywords

Autism; Autism Spectrum Disorder; Virtual Reality; Sensory Sensitivity; Sensory Hyper-reactivity; Sensory Processing; Sensory Over-Responsivity

Outcome Measures

Primary Outcomes (1)

• Changes in neural response to the sensory stimulation

  This will be the change in the bold response as measured by the fMRI scan.

  There are two 1 hour sessions in which the bold response will be measured. The first time point will be during visit 2 of the study. The second time point will be the final visit of the study.

Secondary Outcomes (3)

• Galvanic Skin Response as measured by a physiological recording devices, either an Emotibit or the MRI scanner

  Galvanic skin response will be measured at 3 - 5 time points, ranging from 1 hour and 30 minutes to 3 hours and 30 minutes of data. 15 minutes will be measured at the 2nd and last visit. 1 hour will be collected at each VR visit.

• Changes in skin temperature after going through a sensory habituation protocol, measured by an Emotibit

  Skin temperature will be measured at 1 - 3 time points, ranging from 1 hour to 3 hours of data. 1 hour will be collected at each VR visit.

• Heart rate changes as measured by a physiological recording devices, either an Emotibit or the MRI scanner

  Heart rate will be measured at 3 - 5 time points, ranging from 1 hour and 30 minutes to 3 hours and 30 minutes of data. 15 minutes will be measured at the 2nd and last visit. 1 hour will be collected at each VR visit.

Study Arms (2)

Autism Spectrum Disorder Habituation Group

EXPERIMENTAL

This will be the group of subjects with Autism and sensory over-responsivity. This group will go through a mock-MRI, a pre-habituation MRI, the habituation protocol in virtual reality, and a post-habituation MRI.

Behavioral: Sensory Habituation Protocol

Neurotypical Habitation Group

ACTIVE COMPARATOR

This will be the group of subjects who are neurotypical peers. This group will go through a mock-MRI, a pre-habituation MRI, the habituation protocol in virtual reality, and a post-habituation MRI.

Behavioral: Sensory Habituation Protocol

Interventions

Sensory Habituation Protocol BEHAVIORAL

The first session continues with the Mock MRI, which lasts 10 minutes. Participant's comfort level in VR will be evaluated. At the pre-exposure visit, participants complete an MRI scan on a 3 Tesla MRI, which takes approximately 1 hour \& 15 minutes. It consists of structural \& functional MRI scans. Structural scans require the participant to stay still with eyes closed. Functional scans will require the participant to lie with eyes closed or watch and listen to sensory stimulation. VR exposure will occur across 3 1-hour sessions at most. Participants will be asked to complete a sensory habituation protocol, in which they will watch and listen to sensory stimuli in VR for an increasing amount of time. Between the sensory stimuli, the participant will watch a self-selected video. Finally, the subject will be asked to do a post-exposure MRI visit, which is the same as the pre-exposure visit.

Also known as: Repeated Exposure

Autism Spectrum Disorder Habituation Group; Neurotypical Habitation Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For our patient population
• people with a diagnosis of autism spectrum disorder
• people who have sensory over-responsivity
• can wear a VR headset for up to 20 minutes
• can understand and follow directions
• For neurotypical participants
• can wear a VR headset for up to 20 minutes
• can understand and follow directions

You may not qualify if:

• \) if you have any known visual impairment that will make it difficult to watch an object in a VR headset 2) inability to wear a VR headset 3) a history of seizures 4) A subject with orthodontic braces or metallic implants, such as prostheses, shrapnel, or aneurysm clips, or persons with electronic implants, such as cardiac pacemakers. The magnetic field generated by the MRI machine can cause a displacement or malfunctioning of these devices; 5) A subject who is claustrophobic, unable to stay still in the scanner for 40 minutes, or unable to be in the MRI scanner room alone;

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Munroe-Meyer Insitute

Omaha, Nebraska, 68106, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James E Gehringer, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two groups, one group will be subjects with autism spectrum disorder and the second group will be subjects who are neurotypical. Each group will participate in the same habituation protocol.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 7, 2024
• Study Start: January 8, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data will be released after conclusion of data collections (planned for end of 2025), conclusion of data analysis (planned for end of 2026), and submission of publication (planned for end of 2026/early 2027)
• Access Criteria: Data will be made available upon reasonable request.

Locations

US (1)