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Behavioral Intervention

Sensory Habituation for Autism (ASD_VR_RE Trial)

N/A

Waitlist Available

Led By James E Gehringer, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Inability to wear a VR headset

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how individuals with Autism Spectrum Disorder (ASD) and those without respond to an unpleasant visual stimulus using a virtual reality desensitization technique. The study will include 30

Who is the study for?

This trial is for individuals aged 7-35 with Autism Spectrum Disorder (ASD), including those who experience sensory over-responsivity or have a Sensory Processing Disorder. Participants should be able to undergo MRI scans and virtual reality sessions without major issues.

What is being tested?

The study tests a 'Sensory Habituation Protocol' using virtual reality to help people with ASD cope better with unpleasant visual stimuli. It involves practice, pre-exposure, and post-exposure MRI visits along with recording physiological responses during desensitization sessions.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from the VR environment or anxiety due to exposure to unpleasant stimuli. The MRI procedure could cause unease in some participants.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot wear a VR headset.

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I have a history of seizures.

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I cannot stay still for long periods or be alone in small, enclosed spaces.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in neural response to the sensory stimulation

Secondary study objectives

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Autism Spectrum Disorder Habituation GroupExperimental Treatment1 Intervention

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.

Group II: Neurotypical Habitation GroupActive Control1 Intervention

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.

0 / 3Eligibility criteria met