Trial Outcomes & Findings for Sensory Habituation in Autism Spectrum Disorders (NCT NCT06247176)
NCT ID: NCT06247176
Last Updated: 2026-05-29
Results Overview
This will be the change in the bold response as measured by the fMRI scan.
TERMINATED
NA
1 participants
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.
2026-05-29
Participant Flow
Participant milestones
| Measure |
Autism Spectrum Disorder Habituation Group
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.
|
Neurotypical Habitation Group
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.
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|---|---|---|
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Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensory Habituation in Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Autism Spectrum Disorder Habituation Group
n=1 Participants
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.
|
Neurotypical Habitation Group
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Handedness
Right Handed
|
1 Participants
n=51 Participants
|
—
|
1 Participants
n=65 Participants
|
|
Handedness
Left Handed
|
0 Participants
n=51 Participants
|
—
|
0 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Project was terminated before full scale analysis was performed.
This will be the change in the bold response as measured by the fMRI scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: Project was terminated before full scale analysis was performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: Project was terminated before full scale analysis was performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: Project was terminated before full scale analysis was performed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Autism Spectrum Disorder Habituation Group
Neurotypical Habitation Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place