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The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808782
First Posted: December 16, 2008
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayside Health
  Purpose

Theory of mind (ToM) refers to the ability to infer others mental states. It includes a recognition that other individuals experience thoughts, feelings, intentions, and desires that may be different to our own. ToM is often impaired among individuals with an autism spectrum disorder (such as autism and Asperger's disorder), and may underlie aspects of social dysfunction in this population. Indeed, it has been suggested that impaired ToM is the core deficit of autism and Asperger's disorder.

Imaging studies suggest that the bilateral medial prefrontal cortex, the most important brain region in ToM processing, is underactive in autism. The current study examines whether repetitive transcranial magnetic stimulation (rTMS) to the bilateral medial prefrontal cortex can modulate ToM ability among healthy adults, and improve ToM ability among adults with autism or Asperger's disorder. With the prevalence of autism increasing, there is a clear need to develop appropriate therapeutic interventions to improve social functioning.

This study involves a double-blind study using high-frequency rTMS in an attempt to improve ToM among adults with either autism or Asperger's disorder. Theory of mind will be measured using behavioural tasks that require the participant to infer what someone is thinking or feeling by observing their behaviour. These tasks will administered both before and after rTMS to determine whether any change in theory of mind has occurred.

Thirty adults with either autism (n = 15) or Asperger's disorder (n = 15) will initially undergo functional and structural MRI to determine the site on the scalp that lies over the medial prefrontal cortex (to which rTMS will be administered). They will then attend our lab each consecutive weekday for a two-week period, during which they will 15 minutes high-frequency (5 Hz) rTMS (either active or sham) to the medial prefrontal cortex. ToM and clinical measures will be collected before the first session, soon after the last session, and one month after the last session.

Based on prior imaging data, it is expected that high-frequency rTMS (compared with sham rTMS) to the medial prefrontal cortex will improve ToM ability and reduce social dysfunction among adults with autism or Asperger's disorder. Should these hypotheses be supported, it will indicate the suitability of rTMS as a neurobiological intervention designed to improve ToM and social function among individuals with autism and related disorders.


Condition Intervention
Autistic Disorder Asperger's Disorder Device: Deep rTMS Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Theory of Mind Neurobehavioural Battery [ Time Frame: Pre, Post, One-month Post ]

Secondary Outcome Measures:
  • Autism Spectrum Quotient [ Time Frame: Pre, Post, One-month Post ]

Enrollment: 30
Study Start Date: December 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham rTMS
Sham 5Hz rTMS.
Device: Sham rTMS
Sham (non-active) repetitive transcranial magnetic stimulation over the medial prefrontal cortices. 30 10s 5Hz rTMS trains per day, with a 20 gap between each (15 minutes total), each consecutive weekday for two weeks
Other Name: rTMS Magstim Rapid (Sham).
Experimental: rTMS
Active 5Hz deep TMS.
Device: Deep rTMS
Repetitive transcranial magnetic stimulation targeting the medial prefrontal cortices. 30 10s 5Hz rTMS trains per day, with a 20 gap between each (15 minutes total), each consecutive weekday for two weeks.
Other Name: rTMS Magstim rapid.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or above. DSM-IV-TR diagnosis of either autistic disorder (autism) or Asperger's disorder.

Exclusion Criteria:

  • Hearing or visual impairment. Neurological illness (e.g., epilepsy).
  • Unstable medical condition.
  • History of seizures or convulsions.
  • History of serious head injury. Metal implants or medical devices (e.g., pacemaker, cochlear implant, medication pump) in the head or body. Professional drivers.
  • Machine operators.
  • Women who are pregnant or lactating.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808782


Locations
Australia, Victoria
Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Paul B Fitzgerald, MBBS, PhD The Alfred, Monash University
Study Director: Peter G Enticott, BAppSc, PhD The Alfred, Monash University
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00808782     History of Changes
Other Study ID Numbers: 277/07
First Submitted: December 14, 2008
First Posted: December 16, 2008
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Bayside Health:
Pervasive Developmental Disorders
Asperger Syndrome
Autism

Additional relevant MeSH terms:
Disease
Autistic Disorder
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders