- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829161
Sensory Phenotypes of Autism Spectrum Disorder
Sensory Phenotypes of Autism Spectrum Disorder Across Lifespan: Prospective Cohort Study and Sensory-Social Paradigm Establishment
This project plans to establish sensory phenotypes of a Taiwanese ASD cohort across lifespan, including variety of sensory modalities, sensory domains, and clinical correlates.
Also, we will clarify the relationship between sensory phenotypes and social impairment by two specific sensory-social paradigms targeting eye gaze avoidance and social touch anxiety, as well as the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.
Study Overview
Detailed Description
Sensory disturbance of autism spectrum disorder (ASD) are life-long highly-impairing challenges for the individual. Anxiety and fear around the sensory issues significantly threatens the psychological and mental health. As a newly introduced diagnostic criteria of ASD, sensory characteristics becomes a recent focus of ASD research. The ASD population is aging, how their sensory features naturally change with age is particular relevant for their adaptation. However, current literature are limited to childhood and young adults and mostly rely on behavioral report, lacking a clear whole picture of changing sensory phenotype in terms of different sensory modality and sensory domains. Besides, how sensory characteristics in ASD can be quantified by objective measures or explored by qualitative approach, how the sensory sensitivity contributes to the core social deficits in ASD such as eye gaze or social touch avoidance are unclear. This project plans to achieve the following aims:
- Establish sensory phenotypes of a Taiwanese ASD cohort across lifespan, including variety of sensory modalities (i.e., visual, tactile, auditory, smell/taste, proprioception, etc.), sensory domains (i.e., low registration, sensory seeking, sensory sensitivity, and sensory avoiding), and clinical correlates.
- Clarify the relationship between sensory phenotypes and social impairment by two specific sensory-social paradigms targeting eye gaze avoidance and social touch anxiety, which are hallmarks of ASD. Factors of emotion types as well as familiarity of faces or social/object touch will be manipulated to examine how they moderate eye tracking and pupil response.
- Identify the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yi Ling Chien
- Phone Number: 66013 886-2-2312-3456
- Email: ylchien@hotmail.com
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yi Ling Chien, M.D., Ph.D.
- Phone Number: 66013 886-2-2312-3456
- Email: ylchien@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Aim#1
Inclusion Criteria:
- Diagnosis of autism spectrum disorder Aim#2 and #3
ASD group:
Inclusion Criteria:
- Diagnosis of autism spectrum disorder
- Age above 12-40 years old
Exclusion Criteria:
- No diagnosis of autism spectrum disorder
- Pregnant woman
- Metal implant in the body
TD group:
Inclusion Criteria:
- No diagnosis of autism spectrum disorder
- Age above 12-40 years old
Exclusion Criteria:
- History of major psychiatric disorders
- Pregnant woman
- Metal implant in the body
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASD Group
ASD participants, no intervention
|
no intervention
|
TD Group
TD participants, no intervention
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory Profile
Time Frame: 2 years
|
It is a self-report scale covers 6 sensory modalities, including taste/smell, motion, visual, tactile, activity, and auditory sensation.
The scoring method was based on 4-dimension structure, i.e.
Low Registration, Sensation Seeking, Sensory Sensitivity, and Sensation Avoiding.
Higher scores mean worse symptoms for each dimension compared to average healthy controls
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activation through fMRI data
Time Frame: 2 years
|
MRI scanning session consist of eye-avoidance paradign, social touch paradigm and anatomical scan.
Regions of interest for eye avoidance paradigm included brain regions that have been shown to involve face-to-face social and emotional interaction.
ROIs for social touch paradigm select the areas that are known to mediate the processing of visually presented social touch scenes.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yi Ling Chien, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201903126RINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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