Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000476538p
Ethics application status
Submitted, not yet approved
Date submitted
3/04/2024
Date registered
17/04/2024
Date last updated
16/06/2024
Date data sharing statement initially provided
17/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Modulation of executive performance by acute exercise and non-invasive brain stimulation.
Scientific title
Modulating Executive Function through the Interaction of Transcranial Direct Current Stimulation (tDCS) and Exercise Intensity: A Neurophysiological Investigation in healthy adults.
Secondary ID [1] 311874 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning 333444 0
Condition category
Condition code
Mental Health 330119 330119 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial Stages:
1. Initial Assessment (Pre-transcranial direct current stimulation [tDCS]): Participants complete three computerized tasks designed to measure aspects of executive function — cognitive flexibility, response inhibition, and reversal learning. This baseline measurement occurs before any intervention to establish participants' cognitive performance levels prior to the application of acute exercise and tDCS. It is estimated that it will take participants between 8-10 minutes to complete these tasks.
2. Pre-Treatment Randomisation: Following the initial assessment, participants are randomly assigned to engage in one of three conditions on a stationary bike: rest, very light activity (50%-60% of maximal heart rate [mhr], where mhr is calculated by the formula [220-age]), or moderate activity (70%-80% of maximal heart rate) for 20 minutes. To ensure adherence to the exercise protocol, heart rate monitors will be used. Participants complete this stage of testing one-on-one.
3. tDCS Administration: After the exercise, participants receive a total of 20 minutes of tDCS (either active or sham; this is part of a randomized, counterbalanced, and repeated measures component) targeted at the left dorsolateral prefrontal cortex (anode on F3 and cathode on Fp2). For the first 10 minutes of tDCS, participants do not engage in any activity. This 10-minute period is necessary for the tDCS to exert its neurophysiological and cognitive effects.
4. Treatment Phase (During tDCS): Starting from minute 10, participants perform the same executive function tasks they completed during the initial assessment, while tDCS is still being applied. The tDCS is discontinued once the executive function tasks are completed or after 20 minutes. This stage is critical for assessing the immediate impact of tDCS (modulated by preceding exercise) on executive function. In the second testing session, (separated by a minimum of 72 hours to prevent carryover effects of tDCS) participants will receive the alternate tDCS condition (active if they received sham in session 1, and vice versa) and will complete the same exercise conditions and executive function tasks as in the first session.
5. Trial Exit: After completing both testing sessions, each participant concludes their involvement in the study.

All testing will be supervised by the Principal Investigator and carried out by three honours research students at the Mind & Body Lab, Murdoch University, ensuring close monitoring for protocol adherence.
Intervention code [1] 328342 0
Treatment: Devices
Intervention code [2] 328343 0
Treatment: Other
Intervention code [3] 328344 0
Behaviour
Comparator / control treatment
The first control condition includes sham (inactive) tDCS stimulation, whereby 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 is to input a pre-assigned numerical code into the tDCS device to select the experimental condition (sham vs.active). This is a repeated-measure factor.

The second control condition includes a group that is not performing any activity on a stationary bike. This group will be compared to the very light activity and moderate activity groups. This is a between-subjects factor.
Control group
Placebo

Outcomes
Primary outcome [1] 337872 0
Total errors
Timepoint [1] 337872 0
Immediately before tDCS (sham or active) and 10 minutes following tDCS across two experimental sessions.
Primary outcome [2] 337873 0
Total errors
Timepoint [2] 337873 0
Immediately before tDCS (sham or active) and 10 minutes following tDCS across two experimental sessions.
Primary outcome [3] 337874 0
Mean Errors per reversal
Timepoint [3] 337874 0
Immediately before tDCS (sham or active) and 10 minutes following tDCS across two experimental sessions.
Secondary outcome [1] 433561 0
Negative feedback sensitivity
Timepoint [1] 433561 0
Immediately before tDCS (sham or active) and 10 minutes following tDCS across two experimental sessions.

Eligibility
Key inclusion criteria
• Are aged between 18 and 50 years. The upper age limit of 50 years has been chosen based on evidence suggesting the onset of very mild cognitive decline may begin past this age.
• Engage in regular cardiovascular activities (e.g., at least twice a week).
• Agree to fast for 3 hours prior to testing (only water or herbal tea is allowed). This is because glucose levels are known to modulate performance in several cognitive domains. By having all participants fast for 3 hours prior to testing, we aim to control for any potential enhancing effects of glucose on executive function.
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 have a sensitive scalp.
• Have a history of alcohol or drug addiction, or severe psychiatric illness.
• Are receiving drug treatment known to lower the seizure threshold (e.g., treatments for epilepsy).
• Are pregnant.
• Are sleep deprived, meaning you have slept less than 6 hours the night before testing.
• Have metallic dental fillings, orthodontic appliances, a cardiac pacemaker, cochlear implant, and/or surgical clips in your body.
• Have a medical history of migraine or frequent headaches.

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)
The experimenter is using 5 digit codes for the tDCS sham/active conditions which do not reveal the identity of the condition to either the experimenter or the participant.
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

Intervention assignment
Other
Other design features
This study utilizes a mixed design that incorporates elements of both parallel and repeated measures frameworks. Participants are randomly assigned to one of three different exercise conditions, which serve as the between-subjects component. Additionally, all groups are exposed to a repeated within-subjects component, where each participant undergoes both tDCS sham and active conditions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
23/08/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316220 0
University
Name [1] 316220 0
Murdoch University
Country [1] 316220 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Country
Australia
Secondary sponsor category [1] 318402 0
None
Name [1] 318402 0
None
Address [1] 318402 0
Country [1] 318402 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315035 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 315035 0
Ethics committee country [1] 315035 0
Australia
Date submitted for ethics approval [1] 315035 0
05/03/2024
Approval date [1] 315035 0
Ethics approval number [1] 315035 0

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

Contacts
Principal investigator
Name 133494 0
Dr Luca Aquili
Address 133494 0
Murdoch University, School of Psychology, 90 South Street, Murdoch WA 6150
Country 133494 0
Australia
Phone 133494 0
+61 89360 2348
Fax 133494 0
Email 133494 0
[email protected]
Contact person for public queries
Name 133495 0
Luca Aquili
Address 133495 0
Murdoch University, School of Psychology, 90 South Street, Murdoch WA 6150
Country 133495 0
Australia
Phone 133495 0
+61 89360 2348
Fax 133495 0
Email 133495 0
[email protected]
Contact person for scientific queries
Name 133496 0
Luca Aquili
Address 133496 0
Murdoch University, School of Psychology, 90 South Street, Murdoch WA 6150
Country 133496 0
Australia
Phone 133496 0
+61 89360 2348
Fax 133496 0
Email 133496 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of the Principal Investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only.

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator: please email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.