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Trial registered on ANZCTR
Registration number
ACTRN12611000176965
Ethics application status
Approved
Date submitted
14/02/2011
Date registered
15/02/2011
Date last updated
20/10/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Can transcranial direct current stimulation (tDCS) improve mirror system activity in autism spectrum disorders?
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Scientific title
In adults with autism spectrum disorder can active transcranial direct current stimulation (tDCS) improve mirror system activity compared with sham tDCS?
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Secondary ID [1]
253604
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None
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Universal Trial Number (UTN)
U1111-1119-4598
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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:
High-functioning autism
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Asperger's disorder
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Condition category
Condition code
Mental Health
259317
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0
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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
Transcranial direct current stimulation (tDCS). This will be applied to the left inferior frontal cortex or left inferior parietal cortex with a neuroConn GBH/Eldith DC Stimulator. Anodal or cathodal tDCS will be delivered for 20 minutes at an intensity of 2mA. tDCS will be delivered during three one-hour sessions (one anodal, one cathodal, and one sham, described below) that will be one-week apart. The overall duration of involvement in the study is therefore two weeks.
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Intervention code [1]
258027
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Treatment: Devices
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Comparator / control treatment
Sham transcranial direct current stimulation (tDCS). This involves placing the electodes in the same positions as for active tDCS. Electrical stimulation, however, ceases after the first 60 seconds (in order to generate the same initial tingling sensation and ensure blinding is maintained).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Corticospinal excitability (CSE) during action observation relative to CSE during static observation. This is achieved by administered single transcranial magnetic stimulation (TMS) pulses to the left primary cortex, and recording responses from the right hand muscles using electromyography, while the participant watches a series of short video clips.
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Assessment method [1]
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Timepoint [1]
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Immediately after tDCS in each of the three tDCS sessions.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
There will be two groups: individuals diagnosed with ASD and typically developing individuals (to act as a comparison group).
Individuals with ASD: Diagnosis of autism (high-functioning) or Asperger's disorders (ASD group only).
Typically developing individuals: No history of psychiatric or neurological illness.
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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?
Yes
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Key exclusion criteria
For both groups: History of epilepsy or seizure activity; history of serious head injury; occupation as a professional driver or machine operator; history of stroke; metal in the head; hearing or visual impairment; neurological condition; psychiatric/neurodevelopmental condition (apart from ASD in the ASD group); genetic disorder.
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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?
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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
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2011
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Actual
1/06/2011
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Date of last participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Faculty of Medicine, Nursing and Health Sciences, Monash University
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Address [1]
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Monash University
Wellington Rd
Clayton VIC 3800
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr. Peter Enticott
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Address
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
257634
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Human Research Ethics Committee
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Ethics committee address [1]
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Ethics Office
Ground Floor, Linay Pavilion
The Alfred
Melbourne VIC 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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21/02/2011
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Approval date [1]
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25/03/2011
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Ethics approval number [1]
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75/11
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Ethics committee name [2]
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Monash University Human Research Ethics Committee
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Ethics committee address [2]
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Monash Research Office, Building 3d, Monash University, Victoria, 3800
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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25/03/2011
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Approval date [2]
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14/04/2011
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Ethics approval number [2]
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CF11/0917 - 2011000460
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Summary
Brief summary
Autism spectrum disorders (ASD) are the second leading cause of disability among Australian boys. Despite this, for many years we have lacked an understanding of the brain impairments that underlie autism, and accordingly we have no biomedical treatments that target the core symptoms. A promising new biological explanation that has emerged within the past decade is the “mirror system hypothesis” of autism, which states that brain regions and neurons devoted to understanding other people, which are known as mirror systems, are deficient in ASD. This study will investigate whether mirror system activity in individuals with ASD can be improved using transcranial direct current stimulation (tDCS). tDCS is a safe and non-invasive method of brain stimulation that can be used to modulate brain activity via electrodes that are placed on the scalp. The study will include 20 individuals with an ASD (either high-functioning autism or Asperger’s disorder) and 20 healthy controls. Participants will attend 3 sessions at the Alfred hospital. During each session participants will undergo assessment of mirror system activity using transcranial magnetic stimulation (TMS) after undergoing 20 minutes of tDCS. Each session will involve a different type of tDCS (anodal, cathodal, and sham/placebo). To determine the effect of tDCS, mirror system activity will be compared within ASD and control groups across the 3 sessions. This research is a significant and novel investigation into an economical and well tolerated method for enhancing brain activity. This may provide an exciting avenue for developing treatments for ASD, a significant direction given the current lack of biomedical treatments for this group of debilitating disorders.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Peter Enticott
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Address
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School of Psychology, Deakin University
221 Burwood Hwy
Burwood VIC 3125
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Country
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Australia
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Phone
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+61 3 9244 5504
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Dr. Peter Enticott
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Address
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MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9076 6594
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Dr. Peter Enticott
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Address
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MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 9076 6594
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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