Radiomics of Autism Spectrum Disorder

NCT ID: NCT05439954

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-01

Brief Summary

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Case group

（a）patients fulfilling the Diagnostic Criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition（DSM-V); (b)age:14 and under 14 years old; (c)first clinic visit, never-treated; (d)without injury to head and other diseases of the nervous system.

No interventions assigned to this group

Control Group

（a）healthy subject of same ages;(b)without injury to head and diseases of the nervous system; (c)without family history of mental disorders; (d)without other somatic illness.

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qingling Chen

OTHER

Sponsor Role: lead

Responsible Party

Qingling Chen

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Fifth Affiliated Hospital at Sun Yat-sen University

Zhuhai, Guangdong, China

Countries

China

Other Identifiers

QL Chen

Identifier Type: -

Identifier Source: org_study_id