Structural and Functional Connectivity in Autism Spectrum Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00755430
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition
Autism Spectrum Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Structural and Functional Connectivity in Autism Spectrum Disorders by Using Diffusion Spectrum Imaging and Functional Magnetic Resonance Imaging Studies

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.


Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
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:

  1. 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;
  2. To correlate the structural and functional dysconnectivity to clinical severity and neuropsychological functioning;
  3. 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
  4. 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.

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755430

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD +886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    +886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD Dept of Psychiatry, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Susan Shur-Fen Gau, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00755430     History of Changes
Other Study ID Numbers: 200807036R
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
autism spectrum disorders (ASD)
structural and functional connectivity
diffusion spectrum imaging (DSI)
functional magnetic resonance imaging (fMRI)
siblings
repeated follow-up measurement

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014