Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000552583
Ethics application status
Approved
Date submitted
19/05/2015
Date registered
29/05/2015
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Working Memory with Transcranial Direct Current Stimulation: The Impact of Combined Prefrontal and Parietal Stimulation
Scientific title
Enhancing Working Memory with Transcranial Direct Current Stimulation: The Impact of Combined Prefrontal and Parietal Stimulation in Healthy Volunteers
Secondary ID [1] 286390 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Working memory in healthy adults 294536 0
Condition category
Condition code
Mental Health 294844 294844 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 295421 295421 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation (tDCS) is a safe, non-invasive, painless technique which has the capacity to temporarily alter cortical excitability and has been shown to improve working memory performance. In this study it is delivered to the dorsolateral prefrontal cortex (DLPFC) and Parietal cortex.

This study employs a randomised, crossover design where participants take part in three separate treatment sessions at least 72 hours apart. Each session involves administration of either active tDCS (either over the DLPFC alone, or DLPFC and parietal cortex), or sham tDCS.

Specifically, participants will receive:

a) Anodal tDCS over the left DLPFC (1.5 mA, 15 minutes)
b) Anodal tDCS over the DLPFC and bilateral parietal cortices (1.5 mA, 15 minutes)
c) Sham tDCS either over the DLPFC or DLPFC and bilateral parietal cortices (counterbalanced, 15 minutes)
Intervention code [1] 291458 0
Treatment: Devices
Comparator / control treatment
The comparator treatment is: Sham tDCS (15 minutes). In the sham treatment, tDCS stimulation is ramped-up to 1.5 mA, held at this intensity for several seconds, then ramped down to 0 mA. This technique generates a sensation on the scalp akin to active tDCS, but does not produce any tangible changes in cortical excitability. Sham stimulation will be delivered over either the DLPFC alone (50% of participants), or DLPFC + PPC (50% of participants), with each participant being randomly assigned to one of these two groups.
Control group
Placebo

Outcomes
Primary outcome [1] 294607 0
N-back task (2-Back, 3-Back) accuracy and reaction time
Digit-span (forwards and backwards)
Timepoint [1] 294607 0
Two separate time-points for each session:
a) Five minutes after tDCS treatment
b) 30 minutes after tDCS treatment
Primary outcome [2] 294608 0
TMS-EEG evoked potentials
Timepoint [2] 294608 0
a) Five minutes after tDCS treatment
b) 30 minutes following tDCS treatment
Secondary outcome [1] 313708 0
EEG oscillations (theta ERS and alpha ERD and gamma frequency)
Timepoint [1] 313708 0
Two timepoints for each session. EEG oscilations recorded during n-back task:

a) Five minutes after tDCS treatment
b) 30 minutes following tDCS treatment

Eligibility
Key inclusion criteria
1) Right-handed adults who have the capacity to provide informed consent.

2) Have no personal history of psychiatric or neurological illness
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Anyone suffering from an unstable medical condition, neurological or psychiatric disorder or any history of a seizure disorder or who are currently pregnant or breastfeeding.

2) Anyone with any metallic implants in the head, a pacemaker, cochlear implant medication pump or other electronic device.

3) Anyone currently taking any psychoactive medications.

4) Professional drivers are not able to participate due to the, albeit relatively low, risk of seizure as this could affect their employment.

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?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Participants will receive both active and sham stimulation in a cross-over design employing a 72 hour wash out period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
6/07/2015
Date of last participant enrolment
Anticipated
Actual
15/12/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290963 0
University
Name [1] 290963 0
Monash University
Country [1] 290963 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road,
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 289644 0
None
Name [1] 289644 0
Address [1] 289644 0
Country [1] 289644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292560 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 292560 0
Ethics committee country [1] 292560 0
Australia
Date submitted for ethics approval [1] 292560 0
27/04/2015
Approval date [1] 292560 0
01/06/2015
Ethics approval number [1] 292560 0
209/15
Ethics committee name [2] 294286 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 294286 0
Ethics committee country [2] 294286 0
Australia
Date submitted for ethics approval [2] 294286 0
02/06/2015
Approval date [2] 294286 0
03/06/2015
Ethics approval number [2] 294286 0
CF15/2285 - 2015000920

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

Contacts
Principal investigator
Name 55938 0
Mr Aron Hill
Address 55938 0
Monash Alfred Psychiatry Research Centre (MAPrc),
Level 4, 607 St Kilda Road
Melbourne, 3004
Country 55938 0
Australia
Phone 55938 0
+61 3 9076 8691
Fax 55938 0
Email 55938 0
[email protected]
Contact person for public queries
Name 55939 0
Aron Hill
Address 55939 0
Monash Alfred Psychiatry Research Centre (MAPrc),
Level 4, 607 St Kilda Road
Melbourne, 3004
Country 55939 0
Australia
Phone 55939 0
+61 3 9076 8691
Fax 55939 0
Email 55939 0
[email protected]
Contact person for scientific queries
Name 55940 0
Aron Hill
Address 55940 0
Monash Alfred Psychiatry Research Centre (MAPrc),
Level 4, 607 St Kilda Road
Melbourne, 3004
Country 55940 0
Australia
Phone 55940 0
+61 3 90768691
Fax 55940 0
Email 55940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval for IPD sharing.


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.