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Trial registered on ANZCTR


Registration number
ACTRN12612001061820
Ethics application status
Approved
Date submitted
3/10/2012
Date registered
4/10/2012
Date last updated
16/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive enhancement: an investigation of non-invasive electrical brain stimulation methods.
Scientific title
An investigation of non-invasive electrical brain stimulation methods on cognitive enhancement and cortical excitability in people with major depression and healthy controls.
Secondary ID [1] 281337 0
1/12/0449
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 287562 0
Condition category
Condition code
Mental Health 287887 287887 0 0
Depression
Mental Health 287893 287893 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 1 mA transcranial direct current stimulation (tDCS)
Arm 2: 1 mA transcranial random noise stimulation (rRNS) with a 1mA DC offset

All excitatory stimulation will be applied to the left dorsolateral prefrontal cortex for 20 minutes using a neuroConn GBH/Eldith DC Stimulator.
Intervention code [1] 285801 0
Treatment: Devices
Comparator / control treatment
Arm 3: Sham stimulation.
This will involve placing the electrodes in the same position as for active sessions, however stimulation will be ceased after 30 seconds (so as to generate the same initial sensation and ensure blinding is maintained).
Control group
Placebo

Outcomes
Primary outcome [1] 288103 0
Stimulation will be delivered concurrent with a mathematical task and the primary outcome measure will be a between groups comparison of task proficiency.
Timepoint [1] 288103 0
During application of active/sham stimulation
Secondary outcome [1] 299431 0
Resting EEG activity
Timepoint [1] 299431 0
Pre and post application of active/sham stimulation
Secondary outcome [2] 299438 0
EEG activity during completion of a working memory task
Timepoint [2] 299438 0
Pre and post application of active/sham stimulation
Secondary outcome [3] 299439 0
DLPFC cortical inhibition measured via TMS/EEG
Timepoint [3] 299439 0
Pre and post application of active/sham stimulation
Secondary outcome [4] 334917 0
Performance on a verbal working-memory task
Timepoint [4] 334917 0
Pre and post application of active/sham stimulation

Eligibility
Key inclusion criteria
Major Depression
1. Able to provide informed consent
2. Meet criteria for a major depressive episode as determined by structured clinical interview.

Healthy Controls
1. Able to provide informed consent
2. Have no history of mental illness as determined by self report and structured clinical interview
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major Depression
1. Comorbid psychotic illness

All Participants
1. Unstable medical condition, neurological disorder or are currently pregnant or lactating
2. Metal in the cranium, a pacemaker, cochlear implant medication pump or other implanted electronic device

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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
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] 286103 0
Self funded/Unfunded
Name [1] 286103 0
Address [1] 286103 0
Country [1] 286103 0
Primary sponsor type
Individual
Name
Dr Rebecca Segrave
Address
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC
3004
Country
Australia
Secondary sponsor category [1] 284915 0
None
Name [1] 284915 0
Address [1] 284915 0
Country [1] 284915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288149 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 288149 0
Ethics committee country [1] 288149 0
Australia
Date submitted for ethics approval [1] 288149 0
02/10/2012
Approval date [1] 288149 0
01/11/2012
Ethics approval number [1] 288149 0

Summary
Brief summary
Recently there has been much interest in the capacity of non-invasive brain stimulation techniques to enhance cognitive processing. The technique that has been most often studied in this regard is transcranial direct current stimulation (tDCS) and there is now robust evidence that tDCS can be used to enhance a variety of cognitive processes. However, the potential of related techniques such as transcranial intermittent current stimulation (tICS) and transcranial random noise stimulation (tRNS) have not yet been investigated in detail, and many unanswered questions remain regarding the neurobiological underpinnings of stimulation induced cognitive enhancement.

A related avenue of research is the emergence of novel cognitive training paradigms for depression. These therapies differ from traditional methods in that they target the cognitive rather than the emotional symptoms of depression. There has been much speculation regarding whether their efficacy could be further enhanced by concurrent application of non-invasive brain stimulation.

The current study will investigate the capacity of three active methods of non-invasive electrical brain stimulation (tDCS, tRNS and tICS) and sham stimulation to enhance prefrontally mediated cognitive processing, in both healthy controls and individuals with major depression. It will address the following questions:

1. Which of these methods best augments cognition?
2. What impact do these methods have on cortical excitability?
3. To what degree do these brain stimulation methods impact on the neural oscillations associated with cognitive processing?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34788 0
Dr Rebecca Segrave
Address 34788 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC
3004
Country 34788 0
Australia
Phone 34788 0
+61 3 9076 6564
Fax 34788 0
Email 34788 0
rebecca.segrave@monash.edu
Contact person for public queries
Name 18035 0
Dr Rebecca Segrave
Address 18035 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran VIC
3004
Country 18035 0
Australia
Phone 18035 0
+61 3 9076 6564
Fax 18035 0
Email 18035 0
rebecca.segrave@monash.edu
Contact person for scientific queries
Name 8963 0
Dr Dr Rebecca Segrave
Address 8963 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran VIC
3004
Country 8963 0
Australia
Phone 8963 0
+ 61 3 9076 5030
Fax 8963 0
Email 8963 0
rebecca.segrave@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