AzTrials
AzTrials

Autism Spectrum DisordersNCT01513629

Structural Connectivity as Imaging Endophenotypes of Autism Spectrum Disorders

An observational study of Autism Spectrum Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Autism spectrum disorders (ASD) is a highly hereditary neuropsychiatric disorder. In children and adolescents worldwide, the prevalence of ASD is estimated at 0.6%. Understanding the biological mechanism of this disorder could potentially facilitate prompt, accurate and personalized therapy. Read more about this study

Who is it for?
Ages 10 to 15 years, men onlyHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorders
How many people
80 participants
Where
1 siteTaiwan
Study dates
1 Oct 2010to 30 Sep 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • Men only
  • Healthy volunteers accepted
  • Child

Study population: High-functioning autism group,family group, and neurotypical group

Who may be able to join

  • 20 males, right handed, age 10-15 years old. Diagnosis of high-functioning autism is made according to the DSM-IV and ICD-10 criteria by senior child psychiatrists experienced in autism assessments and treatments. The patients should have full-scale IQ ≧ 80 and no comorbid diseases.
  • 20 unaffected (discordant) male siblings of patients with high-functioning autism
  • 40 healthy school boys without any psychiatric disorders in the 1st and 2nd degree relatives. The patient group (N=20) and a neurotypical group (N=20) are matched in age,gender and handedness. The family group (N=20) and another neurotypical group (N=20) are matched in age, gender and handedness.

Who cannot join

  • full-scale IQ < 80 and with comorbid diseases
  • large imaging motion artifact

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Center for Optoelectronic Biomedicine, National Taiwan University College of Medicine

    Taipei, 10002

Other trials in Taiwan

About this study

Autism spectrum disorders (ASD) is a highly hereditary neuropsychiatric disorder. In children and adolescents worldwide, the prevalence of ASD is estimated at 0.6%. Understanding the biological mechanism of this disorder could potentially facilitate prompt, accurate and personalized therapy. The dysfunction of fronto-temporal circuitry may explain language impairment in ASD. In addition, pieces of evidence suggest that the abnormality of the cortico-striato-thalamic circuitry might be related to social deficits. However, very little is known how changes in these two circuitries are related to variation in genotypes. Previous reports on ASD using magnetic resonance imaging (MRI) have demonstrated alteration of brain structure. Recent advance in neuroimaging has shown that structural connectivity of a specific circuitry is superior to regional analysis in terms of higher penetrance of genetic effects and better account for behavioral variance. Therefore, it is plausible that connectivity imaging may serve as effective endophenotypes that link clinical manifestation (phenotypes) and the biological variables (genotypes). In the past five years, our lab has established world leading diffusion spectrum imaging techniques, and applied the techniques to clinical studies on ASD, schizophrenia, stroke and epilepsy. The clinical experience and technical strengths provide a strong basis for us to extend to imaging genetics, aiming to determine effective endophenotypes of ASD. Therefore, the goal of this project is to validate structural connectivity of fronto-temporal and cortico-striato-thalamic circuitries as effective imaging endophenotypes of ASD. Specifically, the investigators will achieve the goal through a series of validation. First, the investigators will demonstrate that structural connectivities in the two targeted circuitries are indeed different among groups of patients with ASD, unaffected siblings, and neurotypicals. Second, the investigators will demonstrate in neurotypicals and unaffected siblings that the altered structural connectivities related to social and language impairments are indeed different in carriers of risk genes, i.e. CNTNAP2 and SLC25A12, respectively. Last, the investigators will demonstrate in all participants that the altered structural connectivities are associated with the corresponding behavioral variances in social and language function. This two-year project is a cohort study consisting of three groups, namely patient, unaffected siblings, and control groups matched in age, gender and handedness. The patient and sibling groups consist of 20 boys each, age 10-15 years old, and the control group consists of 40 boys. The examination includes behavior assessment (IQ test, neuropsychological and clinical assessment), MRI study (structure MRI and diffusion spectrum imaging for structural connectivity) and genome scan(specifically candidate genes related to language function, i.e. SLC25A12, and to social function, i.e. CNTNAP2). In conclusion, this is the first cohort project on imaging genetics in Taiwan. The success of this project will facilitate the progress of translational neuroscience in Taiwan. The methodology of validating endophenotype will be readily extended to other psychiatric diseases.

Keywords
Autism spectrum disorders, structural connectivity, diffusion spectrum imaging, sibling, endophenotype
Medical subject headings
Autism Spectrum Disorder

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study start1 Oct 2010
  3. Primary completion30 Sep 2012
  4. Study completion30 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513629
Sponsor's protocol ID
201006032R
Status last verified
Sep 2021
First submitted
16 Jan 2012
Last updated
2 Sep 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.

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