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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

Post administration of active or sham cTBS during each of the three session described previously.

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3125 - Burwood

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

221 Burwood Hwy, Burwood, Victoria, Australia, 3125

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Hwy, Burwood, Victoria, Australia, 3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

221 Burwood Hwy, Burwood, Victoria, Australia, 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/03/2017

Approval date [1]

25/05/2017

Ethics approval number [1]

2017-059

Summary

Brief summary

Motor imagery (MI) refers to the mental simulation of movement in the absence of overt movement. A strong body of evidence suggests that MI activates the human motor system in similar ways to actual movement. For example, the time taken to mentally simulate movement correlates with actual movement time, while there is considerable overlap in the neural systems activated during real and imagined movement. Interestingly, MI based interventions have shown moderate effect at improving motor ability in healthy adults (e.g. athletes) and patient groups (e.g. stroke). In some cases MI appears to be an effective adjunct to actual movement therapies for improving action efficiency. However, evidence as to the efficacy of MI therapies nonetheless remains mixed. Research, in large part, has attributed this to a poor understanding of the neural basis of MI. To this end, the putative role of important ‘motor’ structures such as the primary motor cortex (PMC) and the Supplementary motor cortices (SMA) remain debated. Clarifying the role of the PMC and SMA in MI is critical to developing a unified account of motor control, and the development of effective interventions for those with motor difficulties.

Aim: The proposed study will aim to clarify the role of the PMC and SMA in MI in samples of young adults (18 to 35 years) with and without movement problems.

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

N/A

Contacts

Principal investigator

Name

Dr Christian Hyde

Address

Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125

Country

Australia

Phone

+61 39244 6505

Fax

c.hyde@deakin.edu.au

Contact person for public queries

Name

Christian Hyde

Address

Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125.

Country

Australia

Phone

+61 39244 6505

Fax

c.hyde@deakin.edu.au

Contact person for scientific queries

Name

Christian Hyde

Address

Deakin University, 221 Burwood Hwy, Burwood, Victoria, Australia, 3125.

Country

Australia

Phone

+61 39244 6505

Fax

c.hyde@deakin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Barhoun, P., Fuelscher, I., Do, M., He, J. L., Cer... [More Details]

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No additional documents have been identified.

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