Back to resultsNeurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Primary Purpose
Autism Spectrum Disorder, Asperger Disorder, Pervasive Developmental Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS and functional MRI (Magstim)
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring TMS, functional MRI, Supplementary motor cortex, Right Temporoparietal junction( RTPJ)
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
Sites / Locations
- New York state Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TMS and fMRI
Arm Description
functional MRI single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
Outcomes
Primary Outcome Measures
Repetitive Behavior Scale-revised
Secondary Outcome Measures
Vineland Maladaptive Behavior Scale
Full Information
NCT ID
NCT01553240
First Posted
July 19, 2011
Last Updated
January 12, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT01553240
Brief Title
Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Official Title
Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator (Dr. Sporn) left the sponsoring institution.
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Asperger Disorder, Pervasive Developmental Disorder
Keywords
TMS, functional MRI, Supplementary motor cortex, Right Temporoparietal junction( RTPJ)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS and fMRI
Arm Type
Experimental
Arm Description
functional MRI
single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
Intervention Type
Device
Intervention Name(s)
TMS and functional MRI (Magstim)
Other Intervention Name(s)
Magstim, Magstim 200, BISTIM Module
Intervention Description
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.
Primary Outcome Measure Information:
Title
Repetitive Behavior Scale-revised
Time Frame
during screening
Secondary Outcome Measure Information:
Title
Vineland Maladaptive Behavior Scale
Time Frame
during screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Sporn, MD
Organizational Affiliation
NYPI, Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Lisanby, MD
Organizational Affiliation
NYPI, Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
New York state Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11055459
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. doi: 10.1023/a:1005596502855.
Results Reference
result
PubMed Identifier
11439754
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. Erratum In: J Autism Dev Disord 2001 Dec;31(6):603.
Results Reference
result
Citation
Roid, G.H. Stanford Binet Intelligence Scles, Fifth Edition ( Riverside Publishing, Itasca, IL, 2003)
Results Reference
result
PubMed Identifier
7814313
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. doi: 10.1007/BF02172145.
Results Reference
result
PubMed Identifier
11055457
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.
Results Reference
result
Citation
APA. Diagnostic and Statistical Manual of Mental States Disorders. 4th ed. DSM-4-R( American Psychiatric Association, Washington, DC,2000)
Results Reference
result
Citation
Sparrow, S., Cicchetti, D. & Balla,D. The Vineland-2 Adaptive Behavior Scales( Survey Interview Form) ( American Guidance Service, Circle Pines, MN, 2005)
Results Reference
result
Citation
Constantino, J.N. The Social responsiveness Scale. ( Western psychological Services, Los Angeles, 2002)
Results Reference
result
PubMed Identifier
9363580
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.
Results Reference
result
PubMed Identifier
11280420
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.
Results Reference
result
PubMed Identifier
9474057
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.
Results Reference
result
PubMed Identifier
8913194
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.
Results Reference
result
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Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies
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