Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000162910
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
14/02/2020
Date last updated
8/07/2022
Date data sharing statement initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of individualised transcranial magnetic stimulation (TMS) on cognitive functioning in healthy volunteers
Scientific title
Effect of individualised site positioning with transcranial magnetic stimulation (TMS) on cognitive functioning in healthy volunteers
Secondary ID [1] 300390 0
None
Universal Trial Number (UTN)
U1111-1247-4121
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive functioning 316013 0
Condition category
Condition code
Mental Health 314288 314288 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A first experimental session will be conducted to determine the 'optimal' and 'suboptimal' sites for transcranial magnetic stimulation (TMS) using a cognitive task. TMS involves the administration of strong, high frequency magnetic pulses to the brain. Participants will be required to complete a cognitive task while receiving TMS to different stimulation sites. The 'optimal' site is that where the largest effect of TMS on performance occurs, and the 'suboptimal' site is that where the smallest effect of TMS occurs. The duration of this session is approximately 1 hr. This session will occur approximately 1 week prior to the first intervention session.

Arm 1: TMS administered by a university student to an optimised, individualised stimulation site for approximately 3 min at the Black Dog Institute. TMS will involve the administration of strong, high frequency magnetic pulses to the brain.

Arm 2: TMS administered by a university student to a suboptimal, individualised stimulation site for approximately 3 min at the Black Dog Institute. TMS will involve the administration of strong, high frequency magnetic pulses to the brain.

Arm 1 and Arm 2 will be conducted at least 2 days apart.
Intervention code [1] 316671 0
Treatment: Devices
Comparator / control treatment
Sham TMS will be administered by a university student for approximately 3 min at the Black Dog Institute. A TMS coil will be placed upon the head, though no magnetic stimulation will be delivered.
Control group
Placebo

Outcomes
Primary outcome [1] 322675 0
Reaction time for switch trials on the Task Switching Task. Reaction time will be recorded using a voice key.
Timepoint [1] 322675 0
10 minutes post TMS administration
Secondary outcome [1] 379267 0
Reaction time on the Stroop task
Timepoint [1] 379267 0
Approximately 20 minutes post TMS administration
Secondary outcome [2] 379268 0
Heart rate variability will be recorded using electrocardiogram.
Timepoint [2] 379268 0
Immediately post TMS administration

Eligibility
Key inclusion criteria
Healthy, right handed, not taking any concurrent medications which may affect TMS effects (e.g., benzodiazepines), free from any neurological or psychiatric disorder, no recent head injury, no history of seizure or stroke, and no current history of drug or alcohol abuse or dependence.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of any psychiatric or neurological illness, seizure, stroke, any serious medical conditions, or current pregnancy

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
15/03/2021
Actual
30/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304812 0
University
Name [1] 304812 0
University of New South Wales
Country [1] 304812 0
Australia
Primary sponsor type
University
Name
UNSW
Address
Research Ethics & Compliance Support Office, UNSW Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 305135 0
None
Name [1] 305135 0
Address [1] 305135 0
Country [1] 305135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305226 0
UNSW HREC
Ethics committee address [1] 305226 0
Kensington, Sydney
Ethics committee country [1] 305226 0
Australia
Date submitted for ethics approval [1] 305226 0
03/02/2020
Approval date [1] 305226 0
17/04/2020
Ethics approval number [1] 305226 0
HC200065

Summary
Brief summary
In this study we propose to investigate the effects of applying TMS using a novel individualised site targeting methodology with a behavioural outcome for the purpose of enhancing cognitive flexibility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99678 0
Dr Donel Martin
Address 99678 0
Black Dog Institute Bld, Hospital Rd, Randwick, NSW 2031
Country 99678 0
Australia
Phone 99678 0
+61 2 9382 8353
Fax 99678 0
Email 99678 0
[email protected]
Contact person for public queries
Name 99679 0
Dr Donel Martin
Address 99679 0
Black Dog Institute Bld, Hospital Rd, Randwick NSW 2031
Country 99679 0
Australia
Phone 99679 0
+61 2 9382 8353
Fax 99679 0
Email 99679 0
[email protected]
Contact person for scientific queries
Name 99680 0
Dr Donel Martin
Address 99680 0
Black Dog Institute Bld, Hospital Rd, Randwick, NSW 2031
Country 99680 0
Australia
Phone 99680 0
+61 2 9382 8353
Fax 99680 0
Email 99680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication. No end date determined.
Available to whom?
Researchers with ethics approval
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.