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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00808782
Registration number
NCT00808782
Ethics application status
Date submitted
14/12/2008
Date registered
16/12/2008
Date last updated
7/02/2013
Titles & IDs
Public title
The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder
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Scientific title
The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder
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Secondary ID [1]
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277/07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autistic Disorder
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Asperger's Disorder
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Condition category
Condition code
Mental Health
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Deep rTMS
Treatment: Devices - Sham rTMS
Sham Comparator: Sham rTMS - Sham 5Hz rTMS.
Experimental: rTMS - Active 5Hz deep TMS.
Treatment: Devices: 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.
Treatment: Devices: 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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Theory of Mind Neurobehavioural Battery
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Assessment method [1]
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Timepoint [1]
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Pre, Post, One-month Post
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Secondary outcome [1]
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Autism Spectrum Quotient
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Assessment method [1]
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Timepoint [1]
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Pre, Post, One-month Post
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Eligibility
Key inclusion criteria
- 18 years or above. DSM-IV-TR diagnosis of either autistic disorder (autism) or
Asperger's disorder.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2012
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00808782
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Paul B Fitzgerald, MBBS, PhD
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Address
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The Alfred, Monash University
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00808782
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