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Behavioral Intervention

Autism Spectrum Disorder Habituation Group for Sensory Over-Responsivity (ASD_VR_RE Trial)

N/A

Recruiting

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

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

ASD_VR_RE Trial 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.Check my eligibility

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.See study design

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.

ASD_VR_RE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in neural response to the sensory stimulation

Secondary outcome measures

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

ASD_VR_RE 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,714 Total Patients Enrolled

James E Gehringer, PhDPrincipal InvestigatorUniversity of Nebraska

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for this ongoing medical study?

"As documented on clinicaltrials.gov, this research endeavor is presently seeking eligible participants. Commencing its publication on January 8th, 2024, the study has been recently revised as of January 30th, 2024."

Answered by AI

Am I eligible to enroll in this clinical trial?

"Participants aged between 7 and 18 years with a diagnosis of autism are eligible for enrollment in this research study, which aims to recruit a total of 20 individuals."

Answered by AI

Is the research trial open to individuals younger than 45 years old?

"Entrants to this research initiative must fall between 7 and 18 years of age. Notably, there are a total of 260 trials catering specifically to minors under the age of majority, while only 63 studies target older individuals above 65 years old."

Answered by AI

What is the cap on participant enrollment for this research investigation?

"Yes, information available on clinicaltrials.gov indicates that this current medical study is actively enrolling participants. The trial was initially listed on January 8, 2024 and last revised on January 30, 2024. There is a requirement to recruit 20 patients from one designated location."

Answered by AI