Autism Spectrum DisorderNCT00755430
Structural and Functional Connectivity in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological study. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2009to 31 Dec 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The sample will consist of 50 children with DSM-IV ASD (autistic disorder and Asperger's disorder) aged 3-15, their siblings, and 50 age-, sex-, and handedness-matached healthy controls.
Who may be able to join
- The inclusion criteria for the subjects with ASD are:
- that subjects have a clinical diagnosis of autistic disorder, or Asperger disorder defined by the DSM-IV and ICD-10, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits;
- their ages range from 3 to 15 when we conduct the study;
- subjects and their biological parents (and siblings if any) consent to participate in this study for completing clinical and brain imaging assessments and blood withdraw for genetic study (this criteria also applied to the controls).
Who cannot join
- The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV:
- Schizophrenia
- Schizoaffective Disorder
- Organic Psychosis
- severe neurological disease. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with MRI assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structural and Functional Connectivity in Autism Spectrum Disorders by Using Diffusion Spectrum Imaging and Functional Magnetic Resonance Imaging Studies
Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological study. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.
Read the detailed description
Autism spectrum disorder (ASD) is a pervasive neuro-developmental disorder with prominent reciprocal social and communication impairment and restricted repetitive behavior or interest. Because ASD runs in family, because there is no effective biological treatment, and because early intervention can lead to better outcomes, ASD has been given a high priority for genetic and neurobiological study. Although abnormal brain structure has been reported, there is limited data regarding structural and functional dysconnectivity in autism. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We thus propose this prospectively follow-up brain imaging study on ASD.
Specific Aims:
- To investigate the location and extend of structural and functional dysconnectivity and their changes over a 2-year period among children with ASD, as compared to their unaffected siblings and normal controls;
- To correlate the structural and functional dysconnectivity to clinical severity and neuropsychological functioning;
- To test the association between brain dysconnectivity and several candidate genes related to the CNS patterning (e.g., RELN, En-2, Wnt, bcl-2); and
- To test whether neuropsychological and brain imaging findings can be the intermediate phenotype of ASD for genetic studies.
We will recruit 50 children with DSM-IV ASD (autistic disorder and Asperger's disorder) aged 3-15, their siblings, and 50 age-, sex-, and handedness-matached healthy controls. A number of instruments will be used to measure autistic symptoms, functional levels, and cognitive ability (i.e. ADI-R, ADOS, SCQ, SRS, and CAST; WISC-III (WPPSI-R, Bayley), DDST, CPM, and SPM; CPT, WCST, Cambridge Neuropsychological Test Automated Batteries). We will also look directly at the brain for structural and functional connectivity using the DSI and fMRI, respectively. We will repeat the assessments at a 2-year interval. The major tasks consisted of five parts: (1) 3 months-recruitment of subjects, researcher training, and pilot study; (2) 1 years 6 months-clinical, neuropsychological, genetic, DSI and fMRI assessments of 150 subjects; (3) 6 months-data analysis, reports to subjects, and manuscript preparation; (4) 1 years 6 months-same assessment of 150 subjects at a 2-year interval; (5) 4 months-data analysis, reports to subjects, and manuscript preparation.
We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorders (ASD), structural and functional connectivity, diffusion spectrum imaging (DSI), functional magnetic resonance imaging (fMRI), siblings, repeated follow-up measurement
- 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.
- First posted19 Sep 2008 (estimated)
- Study start1 Jan 2009
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755430
- Sponsor's protocol ID
- 200807036R
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2008
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Connectivity in Autism Spectrum Disorders by Using Diffusion Spectrum Imaging and Functional Magnetic Resonance Imaging Studies
- ClinicalTrials.gov ID
- NCT00755430
- Acronym / sponsor ID
- 200807036R
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorders (ASD), structural and functional connectivity, diffusion spectrum imaging (DSI), functional magnetic resonance imaging (fMRI), siblings, repeated follow-up measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological study. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.
Detailed description
Autism spectrum disorder (ASD) is a pervasive neuro-developmental disorder with prominent reciprocal social and communication impairment and restricted repetitive behavior or interest. Because ASD runs in family, because there is no effective biological treatment, and because early intervention can lead to better outcomes, ASD has been given a high priority for genetic and neurobiological study. Although abnormal brain structure has been reported, there is limited data regarding structural and functional dysconnectivity in autism. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We thus propose this prospectively follow-up brain imaging study on ASD.
Specific Aims:
- To investigate the location and extend of structural and functional dysconnectivity and their changes over a 2-year period among children with ASD, as compared to their unaffected siblings and normal controls;
- To correlate the structural and functional dysconnectivity to clinical severity and neuropsychological functioning;
- To test the association between brain dysconnectivity and several candidate genes related to the CNS patterning (e.g., RELN, En-2, Wnt, bcl-2); and
- To test whether neuropsychological and brain imaging findings can be the intermediate phenotype of ASD for genetic studies.
We will recruit 50 children with DSM-IV ASD (autistic disorder and Asperger's disorder) aged 3-15, their siblings, and 50 age-, sex-, and handedness-matached healthy controls. A number of instruments will be used to measure autistic symptoms, functional levels, and cognitive ability (i.e. ADI-R, ADOS, SCQ, SRS, and CAST; WISC-III (WPPSI-R, Bayley), DDST, CPM, and SPM; CPT, WCST, Cambridge Neuropsychological Test Automated Batteries). We will also look directly at the brain for structural and functional connectivity using the DSI and fMRI, respectively. We will repeat the assessments at a 2-year interval. The major tasks consisted of five parts: (1) 3 months-recruitment of subjects, researcher training, and pilot study; (2) 1 years 6 months-clinical, neuropsychological, genetic, DSI and fMRI assessments of 150 subjects; (3) 6 months-data analysis, reports to subjects, and manuscript preparation; (4) 1 years 6 months-same assessment of 150 subjects at a 2-year interval; (5) 4 months-data analysis, reports to subjects, and manuscript preparation.
We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The sample will consist of 50 children with DSM-IV ASD (autistic disorder and Asperger's disorder) aged 3-15, their siblings, and 50 age-, sex-, and handedness-matached healthy controls.
Key inclusion criteria (4 listed)
- that subjects have a clinical diagnosis of autistic disorder, or Asperger disorder defined by the DSM-IV and ICD-10, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits;
- their ages range from 3 to 15 when we conduct the study;
- subjects and their biological parents (and siblings if any) consent to participate in this study for completing clinical and brain imaging assessments and blood withdraw for genetic study (this criteria also applied to the controls).
Key exclusion criteria (5 listed)
- The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV:
- Schizophrenia
- Schizoaffective Disorder
- Organic Psychosis
- severe neurological disease. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with MRI assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shur-Fen Gau, MD, PhD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, 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 4 inclusion and 5 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 5 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 5 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.