Functional Magnetic Resonance Imaging (fMRI) for the Study of Response Inhibition, and Face and Linguistic Processing in Autism

Autism Clinical Trial

Official title:

fMRI for the Study of Response Inhibition, and Face and Linguistic Processing in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211783
• Other study ID #: GCO# 04-0749
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 26, 2012
• Start date: November 2004
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study investigates face processing, response inhibition and phoneme processing in autistic adults by fMRI.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's Syndrome
• Autism
• Autistic Disorder

Intervention

Procedure:
• fMRI
there is no intervention

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD	Differences in BOLD betweens controls and ASD group BOLD - blood-oxygen-level-dependent contrast	at single study visit	No