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Trial registered on ANZCTR


Registration number
ACTRN12609000954224
Ethics application status
Approved
Date submitted
4/11/2009
Date registered
5/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can repetitive transcranial magnetic stimulation (rTMS) alter motor function in autism and Asperger's disorder?
Scientific title
The use of repetitive transcranial magnetic stimulation to improve movement-related cortical potentials in autism and Asperger's disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 252116 0
Asperger's disorder 252117 0
Condition category
Condition code
Mental Health 252321 252321 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low-frequency repetitive transcranial magnetic stimulation (rTMS). rTMS is a non-invasive procedure that involves the administration of magnetic pulses to the scalp, which are able to stimulate the underlying brain tissue (i.e., cause brain cells to become active). rTMS can be used to either increase or decrease activity in a certain part of the brain.
The application of TMS involves 15 minutes of 1 Hz rTMS (i.e., 1 pulse per second for 15 minutes) to (a) primary motor cortex and (b) supplementary motor area. These are done in separate sessions. All participants will receive both arms, plus the control treatment (Sham rTMS). The order of the three conditions (i.e., rTMS to primary motor cortex, rTMS to supplementary motor area, Sham rTMS) will be randomised. There is one week between each of the three conditions.
Intervention code [1] 241500 0
Treatment: Devices
Comparator / control treatment
Sham repetitive transcranial magnetic stimulation. This involves the administration of rTMS as described in the intervention, but the TMS coil is angled away from the scalp; thus, no magnetic pulses are delivered to the brain.
Control group
Placebo

Outcomes
Primary outcome [1] 253186 0
Movement-related cortical potentials (electroencephalogram [EEG] measures of pre-movement brain activity)
Timepoint [1] 253186 0
Immediately before and after rTMS
Secondary outcome [1] 262122 0
Cortical excitability (measured via TMS)
Timepoint [1] 262122 0
Immediately before and after rTMS

Eligibility
Key inclusion criteria
Diagnosis of high-functionng autism or Asperger's disorder
Minimum age
14 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Epilepsy or other seizure disorder
Metal in the head (outside of the mouth)
History of serious head injury
Comorbid psychiatric or neurological illness
Genetic disorder
Serious medical condition

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243965 0
Charities/Societies/Foundations
Name [1] 243965 0
Cure Autism Now Foundation
Address [1] 243965 0
2 Park Avenue
11th Floor
New York, NY 10016
Country [1] 243965 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 251320 0
Hospital
Name [1] 251320 0
Alfred Hospital
Address [1] 251320 0
Commercial Rd
Melbourne VIC 3004
Country [1] 251320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244081 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 244081 0
The Alfred
Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 244081 0
Australia
Date submitted for ethics approval [1] 244081 0
Approval date [1] 244081 0
09/05/2006
Ethics approval number [1] 244081 0
33/06

Summary
Brief summary
Impairments in motor functioning are well documented in autism and Asperger's disorder, and are associated with specific brain processes. The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) can be used to improve motor function in autism and Asperger's disorder. rTMS involves the administration of magnetic pulses to the scalp, and can be used to alter brain activity. Participants will complete 3 separate sessions (one week apart) in which a different type of rTMS will be administered. They will complete motor tasks before and after each rTMS application, and brain activity will be recorded via electrodes placed on the scalp. It is expected that stimulation of a brain region called the "supplementary motor area," which is involved in preparing movement, will result in an improvement of motor function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30460 0
Address 30460 0
Country 30460 0
Phone 30460 0
Fax 30460 0
Email 30460 0
Contact person for public queries
Name 13707 0
Dr. Peter Enticott
Address 13707 0
Monash Alfred Psychiatry Research Centre
Level 1, Old Baker Building
Commercial Rd
The Alfred
Melbourne VIC 3004
Country 13707 0
Australia
Phone 13707 0
+61 3 9076 6594
Fax 13707 0
Email 13707 0
peter.enticott@med.monash.edu.au
Contact person for scientific queries
Name 4635 0
Dr. Peter Enticott
Address 4635 0
Monash Alfred Psychiatry Research Centre
Level 1, Old Baker Building
Commercial Rd
The Alfred
Melbourne VIC 3004
Country 4635 0
Australia
Phone 4635 0
+61 3 9076 6594
Fax 4635 0
Email 4635 0
peter.enticott@med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary