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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.
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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.
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Secondary ID [1]
281337
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1/12/0449
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Universal Trial Number (UTN)
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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:
Major Depression
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Condition category
Condition code
Mental Health
287887
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0
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Depression
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Mental Health
287893
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
285801
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Treatment: Devices
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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).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Stimulation will be delivered concurrent with a mathematical task and the primary outcome measure will be a between groups comparison of task proficiency.
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Assessment method [1]
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Timepoint [1]
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During application of active/sham stimulation
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Secondary outcome [1]
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Resting EEG activity
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Assessment method [1]
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Timepoint [1]
299431
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Pre and post application of active/sham stimulation
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Secondary outcome [2]
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EEG activity during completion of a working memory task
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Assessment method [2]
299438
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Timepoint [2]
299438
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Pre and post application of active/sham stimulation
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Secondary outcome [3]
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DLPFC cortical inhibition measured via TMS/EEG
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Assessment method [3]
299439
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Timepoint [3]
299439
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Pre and post application of active/sham stimulation
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Secondary outcome [4]
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Performance on a verbal working-memory task
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Assessment method [4]
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Timepoint [4]
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Pre and post application of active/sham stimulation
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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
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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
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
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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
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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
15/11/2012
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Actual
3/11/2014
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Date of last participant enrolment
Anticipated
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Actual
14/02/2017
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Date of last data collection
Anticipated
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Actual
14/02/2017
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Sample size
Target
120
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Accrual to date
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Final
101
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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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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Individual
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Name
Dr Rebecca Segrave
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Address
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, 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]
284915
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Country [1]
284915
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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]
288149
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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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02/10/2012
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Approval date [1]
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01/11/2012
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Ethics approval number [1]
288149
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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?
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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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Dr Rebecca Segrave
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Address
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Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC
3004
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Country
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Australia
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Phone
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+61 3 9076 6564
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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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Dr Rebecca Segrave
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Address
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Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran VIC
3004
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Country
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Australia
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Phone
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+61 3 9076 6564
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Fax
18035
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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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Dr Dr Rebecca Segrave
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Address
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Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran VIC
3004
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Country
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Australia
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Phone
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+ 61 3 9076 5030
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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
Source
Title
Year of Publication
DOI
Embase
Effects of transcranial direct current stimulation and transcranial random noise stimulation on working memory and task-related EEG in major depressive disorder.
2023
https://dx.doi.org/10.1016/j.bandc.2023.106105
N.B. These documents automatically identified may not have been verified by the study sponsor.
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