COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder
Scientific title
The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autistic Disorder 0 0
Asperger's Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders

Study type
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Theory of Mind Neurobehavioural Battery
Timepoint [1] 0 0
Pre, Post, One-month Post
Secondary outcome [1] 0 0
Autism Spectrum Quotient
Timepoint [1] 0 0
Pre, Post, One-month Post

Key inclusion criteria
- 18 years or above. DSM-IV-TR diagnosis of either autistic disorder (autism) or
Asperger's disorder.
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Bayside Health

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Paul B Fitzgerald, MBBS, PhD
Address 0 0
The Alfred, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications