Sensory Phenotypes of Autism Spectrum Disorder

Autism Clinical Trial

Official title:

Sensory Phenotypes of Autism Spectrum Disorder Across Lifespan: Prospective Cohort Study and Sensory-Social Paradigm Establishment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829161
• Other study ID #: 201903126RINA
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: July 12, 2025

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Yi Ling Chien
• Phone: 886-2-2312-3456
• Email: ylchien[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

1. 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.

2. 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.

3. Identify the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 12, 2025
• Est. primary completion date: July 12, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• no intervention
no intervention

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years