Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

NCT ID: NCT01553240

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Autism Spectrum Disorder; Asperger Disorder; Pervasive Developmental Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TMS and fMRI

• functional MRI
• single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)

Group Type: EXPERIMENTAL

TMS and functional MRI (Magstim)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Magstim, Magstim 200, BISTIM Module

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Sporn, MD

Role: PRINCIPAL_INVESTIGATOR

NYPI, Columbia University

Sarah Lisanby, MD

Role: STUDY_CHAIR

NYPI, Columbia University

Locations

New York state Psychiatric Institute

New York, New York, United States

Countries

United States

References

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. doi: 10.1023/a:1005596502855.

Reference Type: RESULT

PMID: 11055459 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11439754 (View on PubMed)

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

Reference Type: RESULT

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. doi: 10.1007/BF02172145.

Reference Type: RESULT

PMID: 7814313 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11055457 (View on PubMed)

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

Reference Type: RESULT

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

Reference Type: RESULT

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 9363580 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11280420 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9474057 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8913194 (View on PubMed)

Other Identifiers

5438

Identifier Type: -

Identifier Source: org_study_id