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Autism Spectrum DisorderNCT01553240

Neurocircuitry of Autism- fMRI and Transcranial Magnetic Stimulation Studies

A study testing TMS and functional MRI (Magstim) in people with Autism Spectrum Disorder and Asperger Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
TMS and functional MRI (Magstim)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jun 2007to Jun 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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,
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York state Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Being tested
TMS and functional MRI (Magstim)
Keywords
TMS, functional MRI, Supplementary motor cortex, Right Temporoparietal junction( RTPJ)
Medical subject headings
Autism Spectrum Disorder, Asperger Syndrome, Child Development Disorders, Pervasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMS and functional MRI (Magstim)Device

    Also called Magstim, Magstim 200, BISTIM Module

    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.

Study groups in NCT01553240
Study groupRoleWhat they receive
TMS and fMRIExperimental* functional MRI * single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)
Receives: Device: TMS and functional MRI (Magstim)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Repetitive Behavior Scale-revised

    Measured: during screening

Secondary outcomes (1)

  1. Vineland Maladaptive Behavior Scale

    Measured: during screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2012 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2010
  4. Study completionJun 2010

Why it stopped: Principal Investigator (Dr. Sporn) left the sponsoring institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553240
Sponsor's protocol ID
5438
Status last verified
Jan 2017
First submitted
19 Jul 2011
Last updated
13 Jan 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11055459

  • 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.

    PubMed 11439754

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

  • 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.

    PubMed 7814313

  • 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.

    PubMed 11055457

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

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

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

  • 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.

    PubMed 9363580

  • 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.

    PubMed 11280420

  • 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.

    PubMed 9474057

  • 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.

    PubMed 8913194

Questions about this trial

What is this clinical trial studying?

A study testing TMS and functional MRI (Magstim) in people with Autism Spectrum Disorder and Asperger Disorder, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repetitive Behavior Scale-revised (time frame: during screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01553240, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.

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