Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001338257
Ethics application status
Approved
Date submitted
16/07/2018
Date registered
9/08/2018
Date last updated
19/11/2020
Date data sharing statement initially provided
10/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of motor cortices in motor imagery
Scientific title
Clarifying the role of the primary motor cortex (PMC) and supplementary motor area (SMA) using continuous theta-burst stimulation (cTBS) and motor imagery (MI) in samples of young adults with and without movement problems
Secondary ID [1] 294586 0
Nil known
Universal Trial Number (UTN)
U1111-1212-3007
Trial acronym
MIMC
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Motor function 307383 0
Condition category
Condition code
Mental Health 306483 306483 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be invited to attend 3 x 1 hour assessment sessions which will each be separated by at least one week.

At the commencement of each session, participants will be given a safety questionnaire to assess their eligibility for Transcranial magnetic stimulation (TMS). Those who meet project eligibility will then proceed with the session. During each session, they will first undergo single-pulse TMS to determine their resting motor threshold, administered by a member of the research team (which includes postgraduate research students). They will then be administered one of the following three continuous theta burst stimulation (cTBS) procedures: active cTBS to either the left primary motor cortex (PMC) or left supplementary motor area (SMA), or sham cTBS to the PMC or SMA. With respect to the latter sham cTBS session, half of participants will have the PMC stimulated during the 'sham' session, and the other half the SMA- this process will be randomized.

During 'active' sessions, cTBS will be delivered at 70% of an individual’s “motor threshold” and involve delivery of 3 pulses within .06 seconds, repeated every .2 seconds (5 times per second) for 40 seconds.

Following administration of the respective cTBS protocol, participants will then complete two computer tasks: one requiring them to determine the laterality of hand stimuli; and the second requiring them to determine whether alphanumeric stimuli presented are the correct or incorrect orientation. Finally, at the end of each session, single-pulse TMS will be re-administered to determine whether resting motor threshold has altered during the session.
Intervention code [1] 301861 0
Behaviour
Comparator / control treatment
The design provides a placebo control condition. That is, the sham cTBS session requires participants to engage in the same protocol as that which they engage in during the active cTBS sessions, but no active stimulation is applied. This is a double-blind process.
Control group
Placebo

Outcomes
Primary outcome [1] 306748 0
Change in performance (efficiency) on a computerized measure of motor imagery (MI), the hand laterality task (HLT). The HLT involved the mental simulation of movement and is a well validated experimental measure of MI.
Timepoint [1] 306748 0
Post administration of active or sham cTBS during each of the three session described previously.
Secondary outcome [1] 349434 0
Change in performance (efficiency) on a computerized measure of visual imagery (VI), the letter rotation task (LRT). The LRT involves the mental movement of an object and is a well-validated experimental measure of VI.
Timepoint [1] 349434 0
Post administration of active or sham cTBS in each of the three sessions.

Eligibility
Key inclusion criteria
Young adults will have age-appropriate motor skill and will not present with a prior diagnosis of a motor related medical disorder, neurodevelopmental disorder or intellectual impairment.

OR

Adults with motor skill significantly below that expected of their age. This atypical motor skill will not be otherwise explained by a relevant diagnosed medical condition, neuro developmental disorder or intellectual disability.
Minimum age
18 Years
Maximum age
40 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
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will complete all three sessions/conditions, the order of which will be randomly allocated according to computerized random generation. As noted below, the participant and researcher administering the treatment (cTBS) will be blinded to the condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Session type will be administered at random within each participant (i.e. active cTBS to the PMC; active cTBS to the SMA; sham cTBS). The sequence will be generated using statistical methods. As noted below, the participant and the researcher administering the cTBS will be blinded to the condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed methods factorial design will be used to determine whether cTBS to the PMC and/or SMA influences performance on a measure of MI and whether this effect differs depending on motor ability.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/06/2017
Date of last participant enrolment
Anticipated
3/12/2020
Actual
Date of last data collection
Anticipated
17/12/2020
Actual
Sample size
Target
30
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23455 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 299202 0
University
Name [1] 299202 0
Deakin University
Country [1] 299202 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood, Victoria, Australia, 3125
Country
Australia
Secondary sponsor category [1] 298465 0
None
Name [1] 298465 0
Address [1] 298465 0
Country [1] 298465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300127 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300127 0
Ethics committee country [1] 300127 0
Australia
Date submitted for ethics approval [1] 300127 0
20/03/2017
Approval date [1] 300127 0
25/05/2017
Ethics approval number [1] 300127 0
2017-059

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

Contacts
Principal investigator
Name 82650 0
Dr Christian Hyde
Address 82650 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125
Country 82650 0
Australia
Phone 82650 0
+61 39244 6505
Fax 82650 0
Email 82650 0
[email protected]
Contact person for public queries
Name 82651 0
Christian Hyde
Address 82651 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125.
Country 82651 0
Australia
Phone 82651 0
+61 39244 6505
Fax 82651 0
Email 82651 0
[email protected]
Contact person for scientific queries
Name 82652 0
Christian Hyde
Address 82652 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125.
Country 82652 0
Australia
Phone 82652 0
+61 39244 6505
Fax 82652 0
Email 82652 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
This was not included in our initial ethics agreement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Barhoun, P., Fuelscher, I., Do, M., He, J. L., Cer... [More Details]

Documents added automatically
No additional documents have been identified.