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Trial registered on ANZCTR

Registration number

ACTRN12612001208897

Ethics application status

Approved

Date submitted

14/11/2012

Date registered

15/11/2012

Date last updated

19/09/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Deep repetitive transcranial magnetic stimulation for autism spectrum disorder

Scientific title

For individuals with autism spectrum disorder, does active deep repetitive transcranial magnetic stimulation (rTMS) as compared to sham deep rTMS improve social relating?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1137-0543

Trial acronym

Linked study record

Health condition

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

Autism spectrum disorder

Autistic disorder

Asperger's disorder

Pervasive developmental disorder - not otherwise specified

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Active deep repetitive transcranial magnetic stimulation. This is a non-invasive means of stimulating the brain via a plastic-coated metallic coil that is placed over the scalp. Stimulation will be provided at 110% of resting motor threshold (i.e., minimum stimulation intensity required to activate the brain's motor system). There will be 18 half-hour treatments in total: every consecutive weekday for three weeks, and then three days the following week. Each session involves the administration of 60 10-second stimulation trains at 5 Hz, with a 20 second inter-train interval. This is identical for both Phas e 1 and Phase 2 of the study, except Phase 1 involves undergoing a one-hour brain imaging (PET) session before and after the treatment course. Participants will only take part in Phase 1 or Phase 2, not both. Phase 1 and Phase 2 will be run in parallel.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Placebo deep repetitive transcranial magnetic stimulation. This involves a simulated procedure in which a coil is placed over the head, no no magnetic pulses are delivered to the brain. The placebo is only used in Phase 2 of the trial; Phase 1 investigates the brain's response to deep repetitive transcranial magnetic stimulation, and is not placebo controlled.

Control group

Placebo

Outcomes

Primary outcome [1]

Social relating as indicated by the Ritvo Autism-Aspergers Diagnostic Scale - Revised (RAADS-R)

Timepoint [1]

Pre treatment, post treatment, one-month post treatment, three-months post treatment, six-months post treatment

Primary outcome [2]

Social relating as measured by the Social Responsiveness Scale (SRS/SRS-A)

Timepoint [2]

Pre treatment, post treatment, one-month post treatment, three-months post treatment, six-months post treatment

Secondary outcome [1]

Social anxiety as measured by the Interpersonal Reactivity Index (IRI)

Timepoint [1]

Pre treatment, post treatment, one-month post treatment, three-months post treatment, six-months post treatment

Secondary outcome [2]

Brain metabolism with 'mentalising' network as measured by positron emission tomography (PET)

Timepoint [2]

Pre treatment, post treatment

Secondary outcome [3]

Accuracy and reaction time on computerised tests of mentalising

Timepoint [3]

Pre treatment, post treatment, one-month post treatment, three-months post treatment, six-months post treatment

Eligibility

Key inclusion criteria

- Formal diagnosis of autism spectrum disorder (either autism, Asperger’s disorder, or pervasive developmental disorder not otherwise specified)
- Measured IQ of 55 or above
- Capacity to provide informed consent for self (adults) or child
- Proficiency in the use and comprehension of English (necessary not only in relation to the process of informed consent, but also the completion of English-language measures).

Minimum age

15 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- History of epilepsy or seizure disorder
- History of serious head injury
- Metal in the head (outside of the mouth)
- Medical/metal implants in the body
- History or neurological/psychiatric illness (other than ASD, but not those psychiatric conditions commonly present in ASD, such as depression and anxiety)
- Unstable medical condition
- Pregnant or lactating
- Professional driver or machine operator

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?

Intervention assignment

Parallel

Other design features

Phase

Phase 1 / Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

1/03/2013

Actual

1/03/2013

Date of last participant enrolment

Anticipated

Actual

8/01/2016

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Brain and Behaviour Research Foundation

Address [1]

60 Cutter Mill Road, Suite 404, Great Neck, New York 11021

Country [1]

United States of America

Primary sponsor type

Individual

Name

Dr. Peter Enticott

Address

Monash Alfred Psychiatry Research Centre, Level 4, 607 St Kilda Rd, Melbourne, Victoria, 3004

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof. Paul Fitzgerald

Address [1]

Monash Alfred Psychiatry Research Centre, Level 4, 607 St Kilda Rd, Melbourne, Victoria, 3004

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof. Abraham Zangen

Address [1]

Brain Stimulation and Behavior lab, Biology-Psychology Program, Ben Gurion University, POB 653, Beer-Sheva, 84105

Country [1]

Israel

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health

Ethics committee address [1]

The Alfred, Commercial Rd, Melbourne, Victoria, 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2012

Approval date [1]

07/01/2013

Ethics approval number [1]

533-12

Ethics committee name [2]

Monash University

Ethics committee address [2]

Monash Research Office, Building 3d, Monash University, Victoria, 3800

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/11/2012

Approval date [2]

29/01/2013

Ethics approval number [2]

Summary

Brief summary

The prevalence of autism spectrum disorder (ASD) is currently estimated at 1 in 88, but there is a distinct lack of validated biomedical treatments that target the core symptoms. Non-invasive brain stimulation techniques, including repetitive transcranial magnetic stimulation (rTMS), have been established as safe and efficacious treatments for a range of psychiatric disorders, particularly depression. We conducted a pilot, placebo-controlled study of deep rTMS (a form of rTMS providing stimulation of brain structures further away from the scalp) among individuals with ASD (n = 28) that involved a conservative two-week course of stimulation, and found evidence of improved social relating among those undergoing active deep rTMS. Following on from our pilot research, this study will examine the underlying mechanism of deep rTMS, and the safety and efficacy of a stronger course of deep rTMS in ASD. 

There will be two phases to this study.

Phase 1 will involve 20 individuals with ASD aged 18 or older. They will undergo positron emission tomography (PET) and clinical assessment before and after receiving 30 minutes of active deep rTMS each weekday for 3 weeks, and for 2 weekdays of the following week. This phase will help to understand the underlying brain mechanism of deep rTMS.

Phase 2 will involve 60 individuals with ASD aged 15 or older. They will receive 30 minutes of either active (n = 30) or sham (placebo) (n = 30) deep TMS each weekday for 3 weeks, and for 2 weekdays of the following week. Clinical assessments will be conducted at five points: (1) before the first treatment, (2) immediately after the last treatment, (3) 1 month after the last treatment, (4) 3 months after the last treatment, and (5) 6 months after the last treatment. These assessments will comprise self-report and parent-report (or significant other-report) questionnaires assessing ASD symptomatology and short experimental measures assessing distinct aspects of social relating (e.g., perception of other’s emotions).

Individuals must have been assessed to have an IQ of 55 or above (i.e., mild intellectual disability, average intelligence, or above average intelligence). Capacity to provide informed consent will be evaluated and monitored for all adult participants. Child participants will require parental consent to participate. 

For Phase 1, it is expected that deep rTMS will enhance activity within the brain’s ‘mentalising network’ (i.e., a series of connected regions devoted to understanding others thoughts, beliefs, intentions, and feelings) and result in clinical improvements to social relating symptoms. For Phase 2, it is expected that active deep rTMS will improve social abilities in ASD, and that these will be maintained after 6 months. Should our hypotheses be supported, it will indicate the possibility of deep rTMS as a neurobiological intervention for ASD.

Trial website

www.maprc.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Paul Fitzgerald

Address

MAPrc
Level 4, 607 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9076 6564

Fax

paul.fitzgerald@monash.edu

Contact person for public queries

Name

Peter Enticott

Address

School of Psychology, Deakin University
221 Burwood Highway
Burwood VIC 3125

Country

Australia

Phone

+61 3 9244 5504

Fax

n/a

peter.enticott@deakin.edu.au

Contact person for scientific queries

Name

Peter Enticott

Address

School of Psychology, Deakin University
221 Burwood Highway
Burwood VIC 3125

Country

Australia

Phone

+61 3 9244 5504

Fax

n/a

peter.enticott@deakin.edu.au

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

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No additional documents have been identified.

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