AzTrials
AzTrials

Autism Spectrum DisorderASD_VR_RENCT06247176

Sensory Habituation in Autism Spectrum Disorders

A study testing Sensory Habituation Protocol in people with Autism Spectrum Disorder and Autism, run by University of Nebraska at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
What is being tested?
Sensory Habituation Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
8 Jan 2024to 7 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 1) 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;

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center, Munroe-Meyer Insitute

    Omaha, Nebraska, 68106

Other trials in United States

About this study

Official title: Neurobiological Mechanisms of Sensory Hyper-sensitivity and Habituation in Autism Spectrum Disorders

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.

Read the detailed 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.

Being tested
Sensory Habituation Protocol
Keywords
Autism, Autism Spectrum Disorder, Virtual Reality, Sensory Sensitivity, Sensory Hyper-reactivity, Sensory Processing, Sensory Over-Responsivity
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Habituation ProtocolBehavioural

    Also called Repeated Exposure

    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.

Study groups in NCT06247176
Study groupRoleWhat they receive
Autism Spectrum Disorder Habituation GroupExperimentalThis 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.
Receives: Behavioral: Sensory Habituation Protocol
Neurotypical Habitation GroupActive comparatorThis 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.
Receives: Behavioral: Sensory Habituation Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Neural Response to the Sensory Stimulation

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

    Measured: 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)
  1. Galvanic Skin Response as Measured by a Physiological Recording Devices, Either an Emotibit or the MRI Scanner

    Galvanic skin response is a measure of how sweaty the skin is and can be used as a measure of the body's stress. We will look at this before during and after the habituation protocol to measure how the body adapts to the sensory stimulation.

    Measured: 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.

  2. Changes in Skin Temperature After Going Through a Sensory Habituation Protocol, Measured by an Emotibit

    This will look at the change in the skins temperature before, during, and after the sensory habituation protocol. This is a measure of the body's response to a stressor.

    Measured: 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.

  3. Heart Rate Changes as Measured by a Physiological Recording Devices, Either an Emotibit or the MRI Scanner

    Changes in heart rate can give an indication of stress and habituation. This will be recorded before, during, and after the habituation protocol to assess how the body reacts.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start8 Jan 2024
  3. Primary completion7 Oct 2024
  4. Study completion7 Oct 2024

Why it stopped: PI no longer at institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06247176
Sponsor's protocol ID
0709-22-EP
Acronym
ASD_VR_RE
Status last verified
Oct 2024
First submitted
22 Jan 2024
Last updated
29 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified MRI scans and physiological responses will be made available after completion of the study.

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Habituation Protocol in people with Autism Spectrum Disorder and Autism, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Neural Response to the Sensory Stimulation (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in