A Multi-dimensional Prospective Study to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders

NCT04878575 | Unknown DMC

• 1 other identifier: 201903105RINB
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.

Conditions

Attention-Deficit Hyperactivity Disorder, Unspecified Type; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Neuropsychological functions: Continuous Performance Test(CPT)

  The 4 dimensions of CPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance

  15 minutes

• Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

  The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making

  1.5 hours

• Structural neuroimaging: Diffusing spectrum imaging (DSI)

  DSI is performed using a pulsed-gradient spin-echo diffusion echo planar imaging (EPI) sequence with 102 diffusion-encoding directions

  1 hour

• Multi-echo resting-state fMRI (rfMRI)

  rfMRI will be used to evaluate resting-state connectivity

  1 hour

Study Arms (3)

ASD group

120 ASD patients (aged 5-18 years)

Other: ASD diagnosis; Other: Psychiatric diagnosis

ADHD group

120 ADHD patients (aged 5-18 years)

Other: Psychiatric diagnosis

TDC group

120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders

Other: Psychiatric diagnosis

Interventions

ASD diagnosis OTHER

Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)

ASD group

Psychiatric diagnosis OTHER

Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5

ADHD group; ASD group; TDC group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

120 ASD and 120 ADHD, aged 4-18 will be recruited from the Department of Psychiatry, National Taiwan Univeristy Hospital(NTUH), or the participants with ASD or ADHD from Taiwan's National Epidemiological Study of Child Mental Disorders (TNESCMD). 120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders.

You may qualify if:

• Clinical diagnosis of autism spectrum disorder or attention-deficit hyperactivity disorder defined by the DSM-5 criteria, made by board-certificated child psychiatrists
• Ages range from 5 to 18
• Both parents are Han Chinese
• Subjects and their parents consented to have repeated assessments at 2 to 3 years later

You may not qualify if:

• Comorbidity with DSM-5 diagnoses of ADHD (TDC group), ASD (ADHD and TDC groups), schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use
• Comorbidity with neurological or systemic disorders
• Having a first degree relative who may have ASD based on family history method assessment (ADHD and TDC groups)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

metabolite (blood) and intestinal microbial (stool)

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

TW (1)