Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000070831
Ethics application status
Not yet submitted
Date submitted
12/01/2012
Date registered
13/01/2012
Date last updated
13/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of minor electrical brain stimulation on everyday attention
Scientific title
In healthy volunteers is active Transcranial Direct Current Stimulation (tDCS) better than sham stimulation at increasing scores on the Test of Everyday Attention (TEA)?
Secondary ID [1] 279709 0
Nil
Universal Trial Number (UTN)
U1111-1127-0739
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Everyday attention 285544 0
Condition category
Condition code
Neurological 285737 285737 0 0
Studies of the normal brain and nervous system
Mental Health 285752 285752 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo one session of Transcranial Direct Current Stimulation (tDCS). During this session, 2 mA of tDCS will be applied for 25 minutes over the right medial prefrontal cortex. Each sponge electrode will be 9 cm2. The position of the electrodes will be defined as:

Primary Electrode: We will place the primary electrode over the right mPFC as identified by the junction of FP2, FZ, and F4 electrode positions of the 10/20 EEG electrode system. 10 participants will receive positive electrode stimulation, 10 will receive negative electrode stimulation, and 10 will receive no stimulation. Participants who receive no stimulation will still have the primary electrode applied to the scalp, however, stimulation will only last for 10-seconds: just long enough to generate a slight tingle and blind the subject to his/her condition.

Secondary Electrode: We will place the secondary electrode over the left primary motor cortex (M1) as identified by the C3 electrode position of the 10/20 electrode system.
Intervention code [1] 284009 0
Other interventions
Comparator / control treatment
Sham Stimulation (same set up with no current moving between electrodes).
Control group
Placebo

Outcomes
Primary outcome [1] 286263 0
Standardized scores on the Test of Everyday Attention (TEA).
Timepoint [1] 286263 0
Pre-stimulation
Immediately following stimulation
Secondary outcome [1] 295467 0
Nil
Timepoint [1] 295467 0
Nil

Eligibility
Key inclusion criteria
Healthy Volunteer
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No presence of the following:
Personal history of epilepsy, head trauma, or neurological illness
History of deep brain stimulation or ablation surgery
Presence of large mass brain lesions
History of schizophrenia, schizoaffective disorder, or rapid-cycling bipolar illness
Cranial metal implants
Medical pump or cardiac pacemaker implants
Actual or possible pregnancy

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)
This protocol will be double-blind. Neither the participant nor investigator will know which condition each participant is in. Although the lead investigator will set up the tDCS device, a second investigator (unblind) will actually turn on/off the device thereby leaving the lead investigator blind. A 39 number randomization list has been compiled using MatLab (to account for possible participant drop outs) and will be followed in order as subjects enroll.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized list compiled using a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284490 0
Self funded/Unfunded
Name [1] 284490 0
Unfunded
Country [1] 284490 0
Primary sponsor type
University
Name
University of Melbourne
Address
UoM
VIC-3010
Country
Australia
Secondary sponsor category [1] 283416 0
None
Name [1] 283416 0
Address [1] 283416 0
Country [1] 283416 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286484 0
Ethics committee address [1] 286484 0
Ethics committee country [1] 286484 0
Date submitted for ethics approval [1] 286484 0
13/01/2012
Approval date [1] 286484 0
Ethics approval number [1] 286484 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33618 0
Address 33618 0
Country 33618 0
Phone 33618 0
Fax 33618 0
Email 33618 0
Contact person for public queries
Name 16865 0
Jared Horvath
Address 16865 0
University of Melbourne
Redmond Barry Building
Rm. 809
VIC - 3010
Country 16865 0
Australia
Phone 16865 0
+61 (0)432466963
Fax 16865 0
Email 16865 0
[email protected]
Contact person for scientific queries
Name 7793 0
Jared Horvath
Address 7793 0
University of Melbourne
Redmond Barry Building
Rm. 809
VIC - 3010
Country 7793 0
Australia
Phone 7793 0
+61 (0)432466963
Fax 7793 0
Email 7793 0
[email protected]

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.