Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000565640
Ethics application status
Not yet submitted
Date submitted
24/05/2014
Date registered
27/05/2014
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing neuroplasticity in the dorsolateral prefrontal cortex using non-invasive brain stimulation: Investigating the effects of repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) on working memory and neuroplasticity in healthy volunteers
Scientific title
Enhancing neuroplasticity in the dorsolateral prefrontal cortex using non-invasive brain stimulation: Investigating the effects of repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) on working memory and neuroplasticity in healthy volunteers
Secondary ID [1] 284579 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroplasticity in healthy volunteers 291870 0
Condition category
Condition code
Mental Health 292221 292221 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 292352 292352 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) are non-invasive brain stimulation techniques which, when applied over the scalp, may be used to alter the excitability of underlying neural tissue.

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 TMS (rTMS or TBS) or sham TMS. Specifically, rTMS will involve the application of TMS pulses delivered over the left dorsolateral prefrontal cortex (DLPFC) at a rate of 10 Hz at 120% of resting motor threshold (RMT). A total of 60 five-second stimulation trains will be delivered, each with a 15 second inter-stimulus interval (total 3000 pulses). TBS will be delivered over the left DLPFC at 80% of RMT. Two-second stimulation trains will be repeated every 10 seconds for a total of 190 seconds. Within each train, 3 pulses will be delivered at 50 Hz every 200 milliseconds (total of 600 pulses).
Intervention code [1] 289356 0
Treatment: Devices
Comparator / control treatment
Sham TMS (TMS coil placed over the scalp at a 90 degree angle which mimics the sensation of active TMS, but does not alter cortical activity).
Control group
Placebo

Outcomes
Primary outcome [1] 292090 0
N-back task accuracy and reaction time
Timepoint [1] 292090 0
Two separate time-points for each session:
a) directly after TMS treatment
b) 30 minutes after TMS treatment
Primary outcome [2] 292091 0
TMS-EEG evoked potential amplitudes
Timepoint [2] 292091 0
a) Immediately after TMS treatment
b) 30 minutes following TMS treatment
Secondary outcome [1] 308196 0
EEG oscillations
Timepoint [1] 308196 0
Two timepoints for each session. EEG oscilations recorded during n-back task:
a) Immediately after TMS treatment
b) 30 minutes following TMS 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
As there is limited data on which to base meaningful power analyses we will aim to recruit 30 participants. However, we will conduct interim analyses at N=20.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289218 0
University
Name [1] 289218 0
Monash University
Country [1] 289218 0
Australia
Primary sponsor type
University
Name
Monash Univeristy
Address
Wellington Road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 287889 0
None
Name [1] 287889 0
Address [1] 287889 0
Country [1] 287889 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290986 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 290986 0
Alfred Hospital,
Commercial Rd,
Prahran
3181 VIC
Ethics committee country [1] 290986 0
Australia
Date submitted for ethics approval [1] 290986 0
07/05/2014
Approval date [1] 290986 0
Ethics approval number [1] 290986 0
193/14

Summary
Brief summary
Repetitive TMS protocols are emerging as promising therapeutic tools for the treatment of a number of psychiatric and neurological conditions. The clinical efficacy of these protocols is likely due in part to their ability to promote lasting neuroplastic changes within the brain.

rTMS and TBS are two commonly used protocols which have shown some success in transiently altering cortical excitability and treating a number of brain-related disorders. To date, however, the comparative effectiveness of these two techniques remains to be thoroughly investigated.

This study will apply rTMS, TBS and sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) in normal healthy participants. Behavioural (n-back task) and neurophysiological (TMS-EEG, EEG oscillations) data will be collected both before and after stimulation, which will provide insight into the effects that each of these stimulation protocols has on both cognitive function and underlying cortical neurophysiology. We anticipate that, compared to sham stimulation, both rTMS and TBS will significantly improve n-back task performance and induce lasting changes in brain activity as measured with combined TMS-EEG and EEG. In addition, we anticipate that these effects will be the strongest following the TBS protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48278 0
Mr Aron Hill
Address 48278 0
MAPrc,
Level 4, 607 St Kilda Rd,
Melbourne, VIC 3004
Country 48278 0
Australia
Phone 48278 0
+61 (0)3 9076 6564
Fax 48278 0
Email 48278 0
[email protected]
Contact person for public queries
Name 48279 0
Aron Hill
Address 48279 0
MAPrc,
Level 4, 607 St Kilda Rd,
Melbourne, VIC 3004
Country 48279 0
Australia
Phone 48279 0
+61 (0)3 9076 6564
Fax 48279 0
Email 48279 0
[email protected]
Contact person for scientific queries
Name 48280 0
Aron Hill
Address 48280 0
MAPrc,
Level 4, 607 St Kilda Rd,
Melbourne, VIC 3004
Country 48280 0
Australia
Phone 48280 0
+61 (0)3 9076 6564
Fax 48280 0
Email 48280 0
[email protected]

No information has been provided regarding IPD availability


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.