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Trial registered on ANZCTR


Registration number
ACTRN12613000947707
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
27/08/2013
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-invasive brain stimulation and cognitive enhancement in healthy volunteers: investigating the effects of theta burst stimulation (TBS) on learning and memory.
Scientific title
Non-invasive brain stimulation and cognitive enhancement in healthy volunteers: investigating the effects of theta burst stimulation (TBS) on learning and memory.
Secondary ID [1] 283064 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
working memory 289904 0
learning 289905 0
Condition category
Condition code
Neurological 290271 290271 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Theta Burst Stimulation (TBS)
TBS is a type of repetitive Transcranial Magnetic Stimulation (rTMS) where high frequency (30 to 50 Hz) of magnetic pulse is given to the superficial areas of the brain in a short period of time.

In the current study, in each session participants will receive a single stimulation course (of either active or sham) lasting 3 mins. Therefore, participants will attend for two sessions (one active and one sham) at least 72 hours apart.
Intervention code [1] 287783 0
Treatment: Devices
Comparator / control treatment
sham TBS. Sham is achieved by administering the same stimulation parameters but by angling the coil away from the scalp.
Control group
Active

Outcomes
Primary outcome [1] 290295 0
Working memory as asssessed by n-back score: 2-back and 3-back
Timepoint [1] 290295 0
0 minutes, 20 minutes, 40 minutes
Secondary outcome [1] 304272 0
brain activity using EEG
Timepoint [1] 304272 0
0 minutes, 20 minutes, 40 minutes
Secondary outcome [2] 304273 0
Oxygenated Hemoglobin concentration in the brain using Near Infra Red Spectroscopy (NIRS)
Timepoint [2] 304273 0
0 minutes, 20 minutes, 40 minutes

Eligibility
Key inclusion criteria
Healthy participants with no history of psychiatric illnesses
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
2. Participants with metal in the cranium, a pacemaker, cochlear implant medication pump or other electronic device.
3. Professional drivers are not able to participate due to the, albeit relatively low, risk of seizure as this may 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)
This is a blinded study. The participant will not know what type of stimulation they recieve. The stimulation condition will be counterbalanced across participants. A spreadsheet containing an active or sham allocation for each session randomised across participants is prepared by the chief investigator prior to recruitment commencing. Following the screening process and once the participant is enrolled in the study randomization takes place. At this time the Chief Investigator, who will be unblinded, will from this spreadsheet assign the order of the stimulation sessions (i.e. active then sham or sham then active).
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


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
There is limited data on which to base meaningful power analyses. We will aim for sample size of 40, and conduct interim analysis at 20 to ensure adequate sample size.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287830 0
University
Name [1] 287830 0
Monash University
Address [1] 287830 0
Wellington Rd, Clayton VIC 3800, Australia
Country [1] 287830 0
Australia
Primary sponsor type
University
Name
Monash Alfred Psychiatry Research Centre (MAPrc)
Address
607 St Kilda Rd, VIC 3004
Country
Australia
Secondary sponsor category [1] 286556 0
Individual
Name [1] 286556 0
Kate Hoy
Address [1] 286556 0
MAPrc

607 St Kilda Rd VIC 3004
Country [1] 286556 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289773 0
OFFICE OF ETHICS & RESEARCH GOVERNANCE
Ethics committee address [1] 289773 0
Ground Floor, Linay Pavilion, The Alfred
55 Commercial Rd, Melbourne VIC 3004, Australia
Ethics committee country [1] 289773 0
Australia
Date submitted for ethics approval [1] 289773 0
21/08/2013
Approval date [1] 289773 0
Ethics approval number [1] 289773 0
375/13

Summary
Brief summary
The purpose of this project is to investigate whether brain stimulation techniques will lead to an improvement of working memory (‘working memory’ refers to the temporary storage and processing of information) in healthy volunteers.

We are conducting a study to see whether TMS applied at the front of the brain can improve performance on tests of working memory. The type of TMS we are using is called Theta Burst Stimulation (TBS). Theta burst stimulation (TBS) is a type of TMS where the magnetic pulses are applied in very short bursts (three pulses at a time) at a high frequency (30-50 pulses a second).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42346 0
Dr Kate Hoy
Address 42346 0
MAPrc
Level 4, 607 St Kilda Rd
Melbourne, 3004
Country 42346 0
Australia
Phone 42346 0
+ 61 3 9076 5034
Fax 42346 0
Email 42346 0
Kate.Hoy@monash.edu
Contact person for public queries
Name 42347 0
Dr Kate Hoy
Address 42347 0
MAPrc
Level 4, 607 St Kilda Rd
Melbourne, 3004
Country 42347 0
Australia
Phone 42347 0
+ 61 3 9076 5034
Fax 42347 0
Email 42347 0
Kate.Hoy@monash.edu
Contact person for scientific queries
Name 42348 0
Dr Kate Hoy
Address 42348 0
MAPrc
Level 4, 607 St Kilda Rd
Melbourne, 3004
Country 42348 0
Australia
Phone 42348 0
+ 61 3 9076 5034
Fax 42348 0
Email 42348 0
Kate.Hoy@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary