Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000871741
Ethics application status
Approved
Date submitted
14/06/2022
Date registered
20/06/2022
Date last updated
20/06/2022
Date data sharing statement initially provided
20/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Degree of habitual behaviour modulation of non-invasive brain stimulation effects on cognitive flexibility in healthy participants.
Scientific title
Degree of habitual behaviour modulation of non-invasive brain stimulation effects on cognitive flexibility in healthy participants.
Secondary ID [1] 307348 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning 326643 0
Condition category
Condition code
Mental Health 323885 323885 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, all participants will first complete a self-report report measure of habitual behaviour called Creatures of Habit Scale.

Second, they will then complete a well-established neuropsychological measure of cognitive flexbility known as the Wisconsin Card Sorting Test. The test will be administered in the lab using a piece of software called PEBL.

Third, they will undergo either cathodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) or sham (control). The order of tDCS allocation will be randomized for each participant. To avoid potential carryover effects of tDCS, as this is a crossover design, each session will be separated by at least 72 hours.

A current at 1.5 mA will be delivered for 10 minutes while the participant is relaxed plus the additional duration of the Wisconsin Card Sorting test (approximately 7 minutes) with additional 30-second fade-in/fade-out periods. A current of 1.5 mA has been selected because 2.0 mA can compromise tDCS blinding in repeated measures/crossover designs.

Testing will be carried out by an honours research student supervised by the PI and carried out in the Mind & Body lab at Murdoch University.
Intervention code [1] 323780 0
Treatment: Devices
Intervention code [2] 323781 0
Behaviour
Comparator / control treatment
For sham (control) stimulation, a current of 1.5 mA will be faded in over 30 seconds and then switched off. Double blinding will be achieved using the neuroConn study mode software and a different experimenter inputted a pre-assigned numerical code into the tDCS device to select the experimental condition (sham vs.cathodal).
Control group
Placebo

Outcomes
Primary outcome [1] 331704 0
Total errors in the Wisconsin Card Sorting task
Timepoint [1] 331704 0
Immediately before tDCS (sham or cathodal) and 10 minutes following tDCS activation across two experimental sessions.
Primary outcome [2] 331705 0
Perseverative errors in Wisconsin Card Sorting Test
Timepoint [2] 331705 0
Immediately before tDCS (sham or cathodal) and 10 minutes following tDCS activation across two experimental sessions.
Primary outcome [3] 331706 0
Reaction times in the Wisconsin Card Sorting task
Timepoint [3] 331706 0
Immediately before tDCS (sham or cathodal) and 10 minutes following tDCS activation across two experimental sessions.
Secondary outcome [1] 410821 0
Failure to maintain set in the Wisconsin Card Sorting task
Timepoint [1] 410821 0
Immediately before tDCS (sham or cathodal) and 10 minutes following tDCS activation across two experimental sessions.

Eligibility
Key inclusion criteria
• You are aged between 18 and 50 years (the upper age limit of 50 years has been selected as there is some evidence that mild cognitive decline begins past this age)
• You are in good health
• You agree to fast 3 hours prior to testing (only water or herbal tea allowed) (glucose levels are known to modulate performance in several cognitive domains. By having all participants fast for 3 hours prior to testing, we can rule out an enhancing effect of glucose on the cognitive flexibility task).
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be able to participate if they:
• Suffer from cardiac, hepatic, renal, and/or neurological disorders
• Have damaged or diseased skin on your face and scalp, or a sensitive scalp
• Have a history of alcohol or drug addiction, or severe psychiatric illness
• Are receiving drug treatment which may lower seizure threshold (i.e. epilepsy)
• Are pregnant
• Are sleep deprived (less than 6 hours a day)
• Have metallic dental fillings, orthodontic appliances, a cardiac pacemaker, cochlear
implant, and/or surgical clips

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)
I, as the researcher randomising the participant do not know what the next treatment allocation will be as testing is carried out by my students.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/06/2022
Date of last participant enrolment
Anticipated
16/09/2022
Actual
Date of last data collection
Anticipated
16/09/2022
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311636 0
University
Name [1] 311636 0
Murdoch University
Country [1] 311636 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, 6150, WA.
Country
Australia
Secondary sponsor category [1] 313073 0
None
Name [1] 313073 0
Address [1] 313073 0
Country [1] 313073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311093 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 311093 0
90 South Street, Murdoch, 6150, WA
Ethics committee country [1] 311093 0
Australia
Date submitted for ethics approval [1] 311093 0
Approval date [1] 311093 0
09/06/2022
Ethics approval number [1] 311093 0

Summary
Brief summary
We are trying to establish whether the degree to which one self-reports to be low or high in habitual behaviour can in turn affect the efficacy of non-invasive brain stimulation on measures of cognitive flexibility. Our hypothesis is that performance on cognitive flexibility will be worst for those high in habitual behaviour when receiving inhibitory non-invasive brain stimulation but not during control/sham stimulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119918 0
Dr Luca Aquili
Address 119918 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119918 0
Australia
Phone 119918 0
+61 89360 2348
Fax 119918 0
Email 119918 0
[email protected]
Contact person for public queries
Name 119919 0
Dr Luca Aquili
Address 119919 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119919 0
Australia
Phone 119919 0
+61 89360 2348
Fax 119919 0
Email 119919 0
[email protected]
Contact person for scientific queries
Name 119920 0
Dr Luca Aquili
Address 119920 0
Murdoch University
90 South Street,
Murdoch, 6150,
WA
Country 119920 0
Australia
Phone 119920 0
+61 89360 2348
Fax 119920 0
Email 119920 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16370Ethical approval    384215-(Uploaded-14-06-2022-16-54-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4818Study results articleYes Yatan, G., Lim, L. W., & Aquili, L. (2023). Routin... [More Details] 384215-(Uploaded-27-03-2023-18-47-51)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRoutine behaviour, a putative dopamine marker, predicts cognitive flexibility by tDCS of the dlPFC.2023https://dx.doi.org/10.1016/j.brs.2023.01.1676
N.B. These documents automatically identified may not have been verified by the study sponsor.