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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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

Scientific title

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

Secondary ID [1]

277/07

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autistic Disorder

Asperger's Disorder

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Intervention/exposure

Study type

Interventional

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Theory of Mind Neurobehavioural Battery

Timepoint [1]

Pre, Post, One-month Post

Secondary outcome [1]

Autism Spectrum Quotient

Timepoint [1]

Pre, Post, One-month Post

Eligibility

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

Sex

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

Treatment

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

Crossover

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/12/2008

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/10/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Psychiatry Research Centre - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/study/NCT00808782

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Paul B Fitzgerald, MBBS, PhD

Address

The Alfred, Monash University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00808782

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00808782