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

NCT00808782 | Completed

• 1 other identifier: 277/07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autistic Disorder; Asperger's Disorder

Keywords

Pervasive Developmental Disorders; Asperger Syndrome; Autism

Outcome Measures

Primary Outcomes (1)

• Theory of Mind Neurobehavioural Battery

  Pre, Post, One-month Post

Secondary Outcomes (1)

• Autism Spectrum Quotient

  Pre, Post, One-month Post

Study Arms (2)

Sham rTMS

SHAM COMPARATOR

Sham 5Hz rTMS.

Device: Sham rTMS

rTMS

EXPERIMENTAL

Active 5Hz deep TMS.

Device: Deep rTMS

Interventions

Deep rTMS DEVICE

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.

Also known as: rTMS Magstim rapid.

rTMS

Sham rTMS DEVICE

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

Also known as: rTMS Magstim Rapid (Sham).

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Alfred Psychiatry Research Centre Home Page

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Paul B Fitzgerald, MBBS, PhD

  The Alfred, Monash University

  PRINCIPAL INVESTIGATOR

• Peter G Enticott, BAppSc, PhD

  The Alfred, Monash University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2008
• First Posted: December 16, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

AU (1)