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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:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00808782
First received: December 14, 2008
Last updated: February 6, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder

Resource links provided by NLM:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00808782     History of Changes
Other Study ID Numbers: 277/07
Study First Received: December 14, 2008
Last Updated: February 6, 2013
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

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014