Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

Autism Spectrum Disorder Clinical Trial

Official title:

Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01553240
• Other study ID #: 5438
• Status: Terminated
• Phase: N/A
• First received: July 19, 2011
• Last updated: January 12, 2017
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asperger Disorder
• Asperger Syndrome
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• Pervasive Developmental Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	New York state Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

APA. Diagnostic and Statistical Manual of Mental States Disorders. 4th ed. DSM-4-R( American Psychiatric Association, Washington, DC,2000)

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. — View 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. — View 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. Erratum i — View Citation

Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. — View Citation

Constantino, J.N. The Social responsiveness Scale. ( Western psychological Services, Los Angeles, 2002)

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 Disor — View Citation

Lord C, Rutter M, Le Couteur A. Autism Diagnostic Interview-Revised: a revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders. J Autism Dev Disord. 1994 Oct;24(5):659-85. — View Citation

Roid, G.H. Stanford Binet Intelligence Scles, Fifth Edition ( Riverside Publishing, Itasca, IL, 2003)

Sparrow, S., Cicchetti, D. & Balla,D. The Vineland-2 Adaptive Behavior Scales( Survey Interview Form) ( American Guidance Service, Circle Pines, MN, 2005)

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. — View 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 Neurophy — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repetitive Behavior Scale-revised		during screening
Secondary	Vineland Maladaptive Behavior Scale		during screening