Simons Variation in Individuals Project, Functional Common Acquisition Protocol
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| First Received Date ICMJE | January 31, 2012 | ||||||||
| Last Updated Date | May 16, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01527578 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Simons Variation in Individuals Project, Functional Common Acquisition Protocol | ||||||||
| Official Title ICMJE | Functional Common Acquisition Protocol Phase of the Simons VIP | ||||||||
| Brief Summary | The University of California, San Francisco (UCSF) Simons Variation in Individuals Project (Simons VIP) is currently recruiting healthy controls for a study aimed at better understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting functional and structural imaging, neuropsychological evaluation, genetic testing, and neurologic exams in healthy individuals to compare with findings in autism spectrum disorder. |
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| Detailed Description | To better understand autism spectrum disorders, the UCSF Simons VIP team is recruiting healthy controls to participate in a study involving brain imaging and psychological assessments and questionnaires. The study will involve phone interviews, cognitive testing and questionnaires, genetic testing, physical exam, photographs, non-invasive brain imaging sessions (MRI and MEG). The study can take up to 17 hours to complete, and there may be up to 5 study visits to UCSF and UC Berkeley. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Healthy individuals ages 7 through 60. |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01527578 | ||||||||
| Other Study ID Numbers ICMJE | Simons VIP F-CAP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | Children's Hospital of Philadelphia | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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