Sensory Phenotypes of Autism Spectrum Disorder | NCT05829161

Studies
Sensory Phenotypes of Autism Spectrum Disorder

NCT05829161

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

480Estimated

Phase

Not provided

Conditions

Autism

Interventions

no intervention

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jul 4, 2019

First Submission Date that Met QC Criteria

Apr 12, 2023

First Posted Date

Apr 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASD Group		ASD participants, no intervention	Behavioral: no intervention
TD Group		TD participants, no intervention	Behavioral: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Behavioral	no intervention	ASD Group TD Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensory Profile	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 Outcomes

Measure	Description	Time Frame
Brain activation through fMRI data	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with autism spectrum disorder, recruited from National Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Ling Chien	Contact	886-2-2312-3456	66013	ylchien@hotmail.com

Overall Officials

Name	Affiliation	Role
Yi Ling Chien	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided