Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

NCT01553240 | Terminated Results DMC

• 1 other identifier: 5438
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Asperger Disorder; Pervasive Developmental Disorder

Keywords

TMS; functional MRI; Supplementary motor cortex; Right Temporoparietal junction( RTPJ)

Outcome Measures

Primary Outcomes (1)

• Repetitive Behavior Scale-revised

  during screening

Secondary Outcomes (1)

• Vineland Maladaptive Behavior Scale

  during screening

Study Arms (1)

TMS and fMRI

EXPERIMENTAL

* 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)

Interventions

TMS and functional MRI (Magstim) 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.

Also known as: Magstim, Magstim 200, BISTIM Module

TMS and fMRI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York state Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (12)

• 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.

  PMID: 11055459 RESULT

• 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.

  PMID: 11439754 RESULT

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

  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.

  PMID: 7814313 RESULT

• 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.

  PMID: 11055457 RESULT

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

  RESULT

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

  RESULT

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

  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.

  PMID: 9363580 RESULT

• 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.

  PMID: 11280420 RESULT

• 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.

  PMID: 9474057 RESULT

• 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.

  PMID: 8913194 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Interventions

Transcranial Magnetic Stimulation; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Linda Sherman
• Organization: New York State Psychiatric Institute

lsherma@nyspi.columbia.edu

(646) 774-7158

Study Officials

• Alexandra Sporn, MD

  NYPI, Columbia University

  PRINCIPAL INVESTIGATOR

• Sarah Lisanby, MD

  NYPI, Columbia University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: March 14, 2012
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 13, 2017
• Results First Posted: January 13, 2017

Record last verified: 2017-01

Locations

US (1)