Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001318178
Ethics application status
Approved
Date submitted
10/09/2019
Date registered
26/09/2019
Date last updated
14/01/2021
Date data sharing statement initially provided
26/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Variability in Response to Theta Burst Stimulation
Scientific title
Investigating Variability in Response to Theta Burst Stimulation: The Predictive Validity of MEP Latency and SICI
Secondary ID [1] 299243 0
Nil
Universal Trial Number (UTN)
U1111-1240-0053
Trial acronym
IVRT
Linked study record
None applicable

Health condition
Health condition(s) or problem(s) studied:
Motor function 314379 0
Condition category
Condition code
Mental Health 312709 312709 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 312842 312842 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be invited to attend two two-hour assessment sessions separated by at least one week. Participants will give written informed consent at the commencement of the first session. Prior to the commencement of TMS in both sessions, participants will be given a safety questionnaire to assess their eligibility for TMS.

Those who meet project eligibility will then proceed by being administered a common battery of single and paired-pulse TMS procedures, administered via a MagStim BiStim2. Then the participants will receive either continuous or intermittent Theta Burst Stimulation (cTBS / iTBS) to the hand node of the primary motor cortex administered via a MagStim Rapid- these sessions will be counter balanced. cTBS will be administered at 50 Hz repeating at 5 Hz giving a total of 600 pulses over 40 seconds. iTBS will be consist of bursts of three pulses delivered at 50 Hz delivered in a two second train repeated every 10 seconds for 20 repetitions giving a total of 600 pulses. TMS will be administered by a trained TMS researcher with 3 years experience.

Five minutes after TBS the participants will receive a group of single TMS pulses applied with two different coil orientations, to assess their response to TBS. These groups will be repeated at five-minute intervals until 30 minutes after TBS. This marks the end of the stimulation and at this point participants will be given a post stimulation safety screening questionnaire to monitor the unlikely occurrence of any negative effects experienced. The second session will be the same as the first session save for the different TBS protocol used (i.e. if session 1 involves cTBS then session 2 will involve iTBS and vice versa).
Intervention code [1] 315538 0
Behaviour
Intervention code [2] 315617 0
Diagnosis / Prognosis
Comparator / control treatment
The alternative TBS approach will act as a control- that is, the cTBS session will act as a comparator to the iTBS session and vice versa since each session is identical aside from the TBS method.
Control group
Active

Outcomes
Primary outcome [1] 321349 0
Change in MEP magnitude from pre and post TBS. That is, MEP amplitude will be measured pre and post TBS using the MagStim BiStim2 (operationalized based on resting motor threshold). This measure will be taken pre and post TBS and compared.
Timepoint [1] 321349 0
Post administration of TBS in each session: 5 minutes post TBS, repeated until 30 mins post TBS in 5 minute intervals.
Secondary outcome [1] 374713 0
N/A
Timepoint [1] 374713 0
N/A

Eligibility
Key inclusion criteria
To be included in the study participants must be healthy adults aged 18 to 45, be proficient in English in order to be able to provide informed consent, and meet the screening criteria outlined below.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone who demonstrates a contra-indication for TMS. This includes (but is not limited to):
• History of seizure
• Previous clinical EEG where presence of seizure activity has not been excluded
• Professional driver or machine operator
• Previous brain surgery or brain injury
• Ferromagnetic metal in the head outside of the mouth
• Implanted medical device
• Serious or unstable illness or medical condition
• Current or suspected pregnancy or current lactation
• Any illicit drug use within past 7 days
• Any alcohol use in past 12 hours, or more than 3 standard drinks in past 24 hours
Recent insomnia or another form of sleep deprivation

Further, children will not be asked to participate in this project since their inclusion is not required (or necessary) for the study aims to be achieved.

People with intellectual or mental impairment and those highly dependent on medical care will be excluded since some health conditions are contraindicators of the TMS procedure that we propose to adopt in this project. These are appropriately (as per Deakin University procedures) screened for as part of the proposed screening protocol described later.

People whose primary language is not English will be disadvantaged on some of the assessment tasks which were developed, and where appropriately normed, for English speaking individuals. Accordingly, these assessments are unlikely to provide a true representation of a non-English speaking individuals' abilities and hence they will be excluded from participation.

In the case of the exclusion of pregnant women, pregnancy is a contraindication of the TMS procedures that we propose to adopt in this project.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will complete all two sessions/conditions, the order of which will be pseudo-randomly allocated according to a blocked design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Session type will be administered at pseudo-random within each participant (i.e. cTBS or iTBS). The sequence will be generated using a blocking method. That is, a set number of participants will receive assessment in one order (cTBS followed by iTBS) and a set number of participants will then receive assessment in the alternative order (e.g. iTBS followed by cTBS).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of regression analyses will be conducted to predict TBS outcome based on MEP latency and SICI respectively

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2019
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
13/04/2021
Actual
Sample size
Target
76
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27993 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 303780 0
University
Name [1] 303780 0
Deakin University
Country [1] 303780 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood, Deakin University, Vic, 3125
Country
Australia
Secondary sponsor category [1] 303904 0
None
Name [1] 303904 0
NA
Address [1] 303904 0
NA
Country [1] 303904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304301 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 304301 0
Ethics committee country [1] 304301 0
Australia
Date submitted for ethics approval [1] 304301 0
01/02/2019
Approval date [1] 304301 0
15/03/2019
Ethics approval number [1] 304301 0
2019-011

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

Contacts
Principal investigator
Name 96450 0
Dr Christian Hyde
Address 96450 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 96450 0
Australia
Phone 96450 0
+61 392446505
Fax 96450 0
Email 96450 0
[email protected]
Contact person for public queries
Name 96451 0
Christian Hyde
Address 96451 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 96451 0
Australia
Phone 96451 0
+61 392446505
Fax 96451 0
Email 96451 0
[email protected]
Contact person for scientific queries
Name 96452 0
Christian Hyde
Address 96452 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 96452 0
Australia
Phone 96452 0
+61 392446505
Fax 96452 0
Email 96452 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
Ethical approval was not given to make individual participant data available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4700Ethical approval    378348-(Uploaded-10-09-2019-19-04-54)-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
4775Study results articleYes Cerins, A., Corp, D., Opie, G., Do, M., Speranza, ... [More Details]

Documents added automatically
No additional documents have been identified.