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Trial record 33 of 72 for:    "Asperger syndrome"

Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

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ClinicalTrials.gov Identifier: NCT01553240
Recruitment Status : Terminated (Principal Investigator (Dr. Sporn) left the sponsoring institution.)
First Posted : March 14, 2012
Results First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
This study uses functional brain imaging and noninvasive brain stimulation techniques to study the brain basis of developmental disorders like Autism Spectrum Disorder and Asperger Disorder. Functional magnetic resonance imaging (fMRI) and recently approved FDA treatment of depression, Transcranial magnetic stimulation (TMS) will be used to study the neurocircuitry of certain symptom clusters in developmental disorders.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Asperger Disorder Pervasive Developmental Disorder Device: TMS and functional MRI (Magstim) Not Applicable

Detailed Description:

The purpose of this research is to study areas of the brain that may have something to do with repetitive movements (things that people do over and over again) and difficulty communicating with other people (problems with talking to, understanding, or just being in a relationships with other people). The investigators are trying to find out why these brain areas are working differently in people with developmental disorders, such as Autism and how the investigators can one day improve them with new brain stimulation techniques.

The investigators will do screening to make sure that you are eligible for the study. After screening, the investigators will do functional MRI. In this procedure the subject or the control will be looking at videos developed to understand their social communication and language skills. The investigators will be able to understand differences of brain activation between patients and control. The investigators will also use TMS to identify the difference of motor excitability between patients and healthy control.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Study Start Date : June 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TMS and fMRI
  • functional MRI
  • single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
Device: TMS and functional MRI (Magstim)
single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging.
Other Name: Magstim, Magstim 200, BISTIM Module




Primary Outcome Measures :
  1. Repetitive Behavior Scale-revised [ Time Frame: during screening ]

Secondary Outcome Measures :
  1. Vineland Maladaptive Behavior Scale [ Time Frame: during screening ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • for Healthy volunteer:

    • no current psychiatric disorder meeting Axis 1 DSM-4 criteria.
    • English speaking,
    • verbal and full scale IQ > 65,
    • capacity to give consent and signed HIPPA authorization.
  • for Autism Spectrum Disorders:

    • diagnosed with Autism, Asperger or Pervasive Developmental Disorder not otherwise specified,
    • English speaking,
    • capacity to give consent and verbal and full scale IQ > 65,
    • signed HIPPA authorization,
    • participants currently taking psychotropic medications must be at the same stable doses and be willing to continue at the same dose through out the study

Exclusion Criteria:

  • for Healthy control and ASD:

    • women of child bearing potential not using birth control pills or breast feeding,
    • h/o bipolar disorder (lifetime),
    • any psychotic disorder( lifetime),
    • history of major depressive disorder or of substance abuse or dependence within the past year,
    • verbal or full scale IQ less than or equal to 65,
    • intracranial implants,
    • metallic implants,
    • shrapnel in the body,
    • metallic braces,
    • cardiac pacemakers or
    • vagus nerve stimulation device,
    • claustrophobia,
    • prior dx of seizure,
    • increased intracranial pressure or history of significant head trauma with loss of consciousness for at least 5 minutes
    • current significant laboratory abnormality,
    • neurological disorder including but not limited to space occupying brain lesion,
    • any history of seizures,
    • history of cerebrovascular accidents,
    • fainting,
    • cerebral aneurysm,
    • dementia,
    • huntington,
    • chorea,
    • multiple sclerosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553240


Locations
United States, New York
New York state Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Alexandra Sporn, MD NYPI, Columbia University
Study Chair: Sarah Lisanby, MD NYPI, Columbia University

Publications of Results:
Roid, G.H. Stanford Binet Intelligence Scles, Fifth Edition ( Riverside Publishing, Itasca, IL, 2003)
APA. Diagnostic and Statistical Manual of Mental States Disorders. 4th ed. DSM-4-R( American Psychiatric Association, Washington, DC,2000)
Sparrow, S., Cicchetti, D. & Balla,D. The Vineland-2 Adaptive Behavior Scales( Survey Interview Form) ( American Guidance Service, Circle Pines, MN, 2005)
Constantino, J.N. The Social responsiveness Scale. ( Western psychological Services, Los Angeles, 2002)

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01553240     History of Changes
Other Study ID Numbers: 5438
First Posted: March 14, 2012    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by New York State Psychiatric Institute:
TMS
functional MRI
Supplementary motor cortex
Right Temporoparietal junction( RTPJ)

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders