Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

January 12, 2017 updated by: New York State Psychiatric Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Not Applicable

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

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

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Magstim, Magstim 200, BISTIM Module

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Repetitive Behavior Scale-revised
Time Frame: during screening
during screening

Secondary Outcome Measures

Outcome Measure
Time Frame
Vineland Maladaptive Behavior Scale
Time Frame: during screening
during screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Alexandra Sporn, MD, NYPI, Columbia University
  • Study Chair: Sarah Lisanby, MD, NYPI, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

March 13, 2012

First Posted (ESTIMATE)

March 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5438 (Other Identifier: NIGMS Sub-Project ID)

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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