Clinical trial NCT01553240: Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Official title: Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Asperger Disorder
Pervasive Developmental Disorder
Keywords: TMS
functional MRI
Supplementary motor cortex
Right Temporoparietal junction( RTPJ)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Repetitive Behavior Scale-revised
timeFrame: during screening
Secondary outcomes:
measure: Vineland Maladaptive Behavior Scale
timeFrame: during screening
Other outcomes:
Locations:
city: New York
country: United States
facility: New York state Psychiatric Institute
state: New York
Study officials:
affiliation: NYPI, Columbia University
name: Alexandra Sporn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYPI, Columbia University
name: Sarah Lisanby, MD
role: STUDY_CHAIR
References:
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citation: Baron-Cohen S, Wheelwright S, Skinner R, Martin J, Clubley E. The autism-spectrum quotient (AQ): evidence from Asperger syndrome/high-functioning autism, males and females, scientists and mathematicians. J Autism Dev Disord. 2001 Feb;31(1):5-17. doi: 10.1023/a:1005653411471.
citation: Roid, G.H. Stanford Binet Intelligence Scles, Fifth Edition ( Riverside Publishing, Itasca, IL, 2003)
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citation: Lord C, Risi S, Lambrecht L, Cook EH Jr, Leventhal BL, DiLavore PC, Pickles A, Rutter M. The autism diagnostic observation schedule-generic: a standard measure of social and communication deficits associated with the spectrum of autism. J Autism Dev Disord. 2000 Jun;30(3):205-23.
citation: APA. Diagnostic and Statistical Manual of Mental States Disorders. 4th ed. DSM-4-R( American Psychiatric Association, Washington, DC,2000)
citation: Sparrow, S., Cicchetti, D. & Balla,D. The Vineland-2 Adaptive Behavior Scales( Survey Interview Form) ( American Guidance Service, Circle Pines, MN, 2005)
citation: Constantino, J.N. The Social responsiveness Scale. ( Western psychological Services, Los Angeles, 2002)
citation: Baron-Cohen S, Jolliffe T, Mortimore C, Robertson M. Another advanced test of theory of mind: evidence from very high functioning adults with autism or asperger syndrome. J Child Psychol Psychiatry. 1997 Oct;38(7):813-22. doi: 10.1111/j.1469-7610.1997.tb01599.x.
citation: Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.
citation: Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.
citation: Wassermann EM, Grafman J, Berry C, Hollnagel C, Wild K, Clark K, Hallett M. Use and safety of a new repetitive transcranial magnetic stimulator. Electroencephalogr Clin Neurophysiol. 1996 Oct;101(5):412-7.