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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?
Scientific title
In adults with autism spectrum disorder can active transcranial direct current stimulation (tDCS) improve mirror system activity compared with sham tDCS?
Secondary ID [1] 253604 0
None
Universal Trial Number (UTN)
U1111-1119-4598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-functioning autism 261163 0
Asperger's disorder 261164 0
Condition category
Condition code
Mental Health 259317 259317 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 258027 0
Treatment: Devices
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).
Control group
Placebo

Outcomes
Primary outcome [1] 262121 0
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.
Timepoint [1] 262121 0
Immediately after tDCS in each of the three tDCS sessions.
Secondary outcome [1] 273204 0
Nil
Timepoint [1] 273204 0
Nil

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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
VIC

Funding & Sponsors
Funding source category [1] 258497 0
University
Name [1] 258497 0
Faculty of Medicine, Nursing and Health Sciences, Monash University
Address [1] 258497 0
Monash University
Wellington Rd
Clayton VIC 3800
Country [1] 258497 0
Australia
Primary sponsor type
Individual
Name
Dr. Peter Enticott
Address
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 257634 0
None
Name [1] 257634 0
Address [1] 257634 0
Country [1] 257634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260475 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 260475 0
Ethics Office
Ground Floor, Linay Pavilion
The Alfred
Melbourne VIC 3004
Ethics committee country [1] 260475 0
Australia
Date submitted for ethics approval [1] 260475 0
21/02/2011
Approval date [1] 260475 0
25/03/2011
Ethics approval number [1] 260475 0
75/11
Ethics committee name [2] 288394 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 288394 0
Monash Research Office, Building 3d, Monash University, Victoria, 3800
Ethics committee country [2] 288394 0
Australia
Date submitted for ethics approval [2] 288394 0
25/03/2011
Approval date [2] 288394 0
14/04/2011
Ethics approval number [2] 288394 0
CF11/0917 - 2011000460

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32211 0
A/Prof Peter Enticott
Address 32211 0
School of Psychology, Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 32211 0
Australia
Phone 32211 0
+61 3 9244 5504
Fax 32211 0
Email 32211 0
peter.enticott@deakin.edu.au
Contact person for public queries
Name 15458 0
A/Prof Dr. Peter Enticott
Address 15458 0
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country 15458 0
Australia
Phone 15458 0
+61 3 9076 6594
Fax 15458 0
Email 15458 0
peter.enticott@monash.edu
Contact person for scientific queries
Name 6386 0
A/Prof Dr. Peter Enticott
Address 6386 0
MAPrc, Level 1, Old Baker Building
The Alfred
Melbourne VIC 3004
Country 6386 0
Australia
Phone 6386 0
+61 3 9076 6594
Fax 6386 0
Email 6386 0
peter.enticott@monash.edu

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