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The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder
This study is currently recruiting participants.
Verified by Bayside Health, December 2008
Sponsored by: Bayside Health
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00808782
  Purpose

Theory of mind (ToM) refers to the ability to infer other's 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

MedlinePlus related topics: Asperger's Syndrome Autism
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Autism Spectrum Quotient [ Time Frame: Pre, Post, One-month Post ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham rTMS: Sham Comparator
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
rTMS: Experimental
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808782

Contacts
Contact: Peter G Enticott, BAppSc, PhD +61 3 9076 6594 p.enticott@alfred.org.au
Contact: Paul B Fitzgerald, MBBS, PhD +61 3 9076 6564 p.fitzgerald@alfred.org.au

Locations
Australia, Victoria
Alfred Psychiatry Research Centre Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Peter G Enticott, BAppSc, PhD     +61 3 9076 6594     p.enticott@alfred.org.au    
Contact: Paul B Fitzgerald, MBBS, PhD     +61 3 9076 6465     p.fitzgerald@alfred.org.au    
Principal Investigator: Paul B Fitzgerald, MBBS, PhD            
Sub-Investigator: Peter G Enticott, BAppSc, PhD            
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

Alfred Psychiatry Research Centre Home Page  This link exits the ClinicalTrials.gov site

Responsible Party: The Alfred (Bayside Health) and Monash University ( Prof. Paul Fitzgerald )
Study ID Numbers: 277/07
Study First Received: December 14, 2008
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00808782  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: Human Research Ethics Committee

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

Study placed in the following topic categories:
Child Development Disorders, Pervasive
Developmental Disabilities
Clotrimazole
Mental Disorders
Autistic Disorder
Miconazole
Mental Disorders Diagnosed in Childhood
Asperger Syndrome
Tioconazole
Salicylhydroxamic acid

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Disease
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009