AutismNCT00211783
Functional Magnetic Resonance Imaging (fMRI) for the Study of Response Inhibition, and Face and Linguistic Processing in Autism
An observational study of Autism and Asperger's Syndrome, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Asperger's Syndrome
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Thirty adults with ASD and 30
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Asperger's Syndrome
- Being tested
- fMRI
- Keywords
- autism, fMRI, response inhibition, face processing, linguistic processing
- Medical subject headings
- Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Autism | Not described Receives: Procedure: fMRI | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD
Differences in BOLD betweens controls and ASD group BOLD - blood-oxygen-level-dependent contrast
Measured: at single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evdokia Anagnostou, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211783
- Sponsor's protocol ID
- GCO# 04-0749
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI for the Study of Response Inhibition, and Face and Linguistic Processing in Autism
- ClinicalTrials.gov ID
- NCT00211783
- Acronym / sponsor ID
- GCO# 04-0749
- Conditions
- Autism, Asperger's Syndrome
- Keywords
- autism, fMRI, response inhibition, face processing, linguistic processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Sep 2005 (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.
This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Procedure: fMRI |
| Control | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thirty adults with ASD and 30
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIthere is no intervention | Procedure or surgery | Autism |
Primary outcome
BOLD
Time frame: at single study visit
Differences in BOLD betweens controls and ASD group BOLD - blood-oxygen-level-dependent contrast
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 28 Jun 2012.
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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.
Evdokia Anagnostou principal investigator
Icahn School of Medicine at Mount Sinai
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 and Asperger's Syndrome, run by Icahn School of Medicine at Mount Sinai 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 28 Jun 2012. 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.
What does the primary outcome measure?
BOLD (time frame: at single study visit). It is what the study was designed to measure, not a finding.
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 28 Jun 2012.