HealthyNCT01527578
Simons Variation in Individuals Project, Functional Common Acquisition Protocol
An observational study of Healthy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2014
- 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 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy individuals ages 7 through 60.
Who may be able to join
- Healthy persons age 7 and older
- Must use English as primary language
- Must be able to lie still in MRI scanner for two hours
- Must be willing to travel to UCSF and UC Berkeley for up to 5 study visits.
Who cannot join
- Any metal implanted in the body
- Extensive dental work
- History of psychiatric of neurological illness
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Functional Common Acquisition Protocol Phase of the Simons VIP
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Healthy children, Healthy adults, individuals ages 7-60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Elliott Sherr, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527578
- Sponsor's protocol ID
- Simons VIP F-CAP
- Status last verified
- May 2014
- First submitted
- 31 Jan 2012
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Common Acquisition Protocol Phase of the Simons VIP
- ClinicalTrials.gov ID
- NCT01527578
- Acronym / sponsor ID
- Simons VIP F-CAP
- Conditions
- Healthy
- Keywords
- Healthy children, Healthy adults, individuals ages 7-60
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Feb 2012 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy individuals ages 7 through 60.
Key inclusion criteria (4 listed)
- Healthy persons age 7 and older
- Must use English as primary language
- Must be able to lie still in MRI scanner for two hours
- Must be willing to travel to UCSF and UC Berkeley for up to 5 study visits.
Key exclusion criteria (4 listed)
- Any metal implanted in the body
- Extensive dental work
- History of psychiatric of neurological illness
- History of drug or alcohol abuse
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 12 May 2014.
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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.
Elliott Sherr principal investigator
University of California, San Francisco
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 Healthy, run by University of California, San Francisco at 1 site in United States.
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 4 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 12 May 2014. 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 United States. 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 12 May 2014.