- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211783
Functional Magnetic Resonance Imaging (fMRI) for the Study of Response Inhibition, and Face and Linguistic Processing in Autism
June 26, 2012 updated by: Icahn School of Medicine at Mount Sinai
fMRI for the Study of Response Inhibition, and Face and Linguistic Processing in Autism
This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI.
Study Overview
Detailed Description
Fifteen adult outpatients with high functioning autism or Asperger's Syndrome will be recruited.
Fifteen healthy volunteers matched for age and IQ will also be recruited.
Participants will undergo an fMRI scan.
During the scan they will perform a task.
The paradigm is designed to test control inhibition, face processing and language.
Therefore, it includes a go-no go test, a face emotion discrimination test and a linguistic sound.
The subjects are shown a series of faces with happy or sad expressions in random order.
Each face presentation is accompanied by either a standard or variant sound.
The sound stimulus is the English phoneme /oe/.
The variant sound was created by raising the frequency of the standard sound by 20%.
The task consists of four blocks.
During each block the subjects are asked to press a button when they see a happy or sad face depending on the block.
Each block consists of 96 trials lasting 2 seconds and an initial and final fixation period of 40 sec.
For each trial the target image is projected for 500 ms.
There is 1250 ms fixation time allowed for response and 250 ms for jitter.
Twenty-four of the 96 trials are no go trials and 16/96 are sound oddball trials.
The oddball is at least two trials apart (between two variant sounds there are at least two standard sounds).
There are 24 faces displayed in total, 12 female and 12 male.
Faces switch every 16 trials.
Face genders are balanced.
The faces were selected with over 80% congruency except for two faces with congruency of over 72%.
The correlation between sound (2 conditions: standard versus variant) and target condition (go-no go) is zero.
The task was piloted on healthy controls and autistic adults.
All subjects performed well.
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Thirty adults with ASD and 30
Description
Inclusion Criteria:
- Age range of 18-50 years old
- Diagnosis: autism spectrum disorder by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and Autism Diagnostic Interview - Revised (ADI-R)
- Intelligence quotient (IQ) > 80
- Outpatients
Exclusion Criteria:
- Subjects with epilepsy
- Subjects with history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder
- Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
- Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
|
|
Autism
|
there is no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD
Time Frame: at single study visit
|
Differences in BOLD betweens controls and ASD group BOLD - blood-oxygen-level-dependent contrast
|
at single study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evdokia Anagnostou, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 28, 2012
Last Update Submitted That Met QC Criteria
June 26, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO# 04-0749
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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