Clinical trial NCT05829161: Sensory Phenotypes of Autism Spectrum Disorder
Official title: Sensory Phenotypes of Autism Spectrum Disorder Across Lifespan: Prospective Cohort Study and Sensory-Social Paradigm Establishment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with autism spectrum disorder, recruited from National Taiwan University Hospital

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:

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.

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

Primary outcomes:
measure: Sensory Profile
timeFrame: 2 years
Secondary outcomes:
measure: Brain activation through fMRI data
timeFrame: 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi Ling Chien
role: PRINCIPAL_INVESTIGATOR
References: