Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000661178
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
2/05/2019
Date last updated
2/05/2019
Date data sharing statement initially provided
2/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does brain connectivity in healthy adults influence the induction of spatial neglect by non-invasive brain stimulation?
Scientific title
Does parietal cortex connectivity in healthy adults influence the induction of spatial neglect by non-invasive brain stimulation?
Secondary ID [1] 296846 0
'None'
Universal Trial Number (UTN)
U1111-1225-3616
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spatial neglect 310755 0
Condition category
Condition code
Neurological 309446 309446 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial Magnetic Stimulation (TMS)
Prior to the continuous theta burst stimulation (cTBS) intervention, the participant’s resting motor threshold (RMT) will be found by using a TMS stimulator (Magstim Super Rapid stimulator (Magstim Company, Dyfed, UK)) with RMT settings, placed perpendicular to the scalp over the right motor cortex at C4 on the 10/10 EEG cap. Electrodes will be placed over the participant’s left first dorsal interosseous muscle, so that motor evoked potentials can be monitored to devise the individual’s resting motor threshold. 70% of this threshold will then used as the intensity for the cTBS intervention.
The same TMS stimulator will then be used to generate a continuous theta burst stimulation (cTBS). The continuous train (bi-phasic wave form) will be delivered using an air-cooled,
figure-of-eight coil, which will be held perpendicular to the scalp, by the trained, primary examiner over the right parietal cortex, located at P4 according to the 10/10 EEG system. The cTBS will last for 40 seconds, 600 pulses will be applied in three bursts at 50Hz, repeated at 5 H. The intervention will be delivered once to each participant, face to face at the University of South Australia Clinical Trials Facility.
Intervention code [1] 313128 0
Behaviour
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308397 0
Proportion of healthy participants with spatial neglect, measured by the Landmark Task.
Timepoint [1] 308397 0
Measured at four minutes post continuous theta burst stimulation intervention, and compared to a pre-intervention Landmark Task measure.
Secondary outcome [1] 354863 0
Change in brain activity levels, measured with electroencephalography (EEG).
Timepoint [1] 354863 0
Electroencephalography measures taken at 1 minute and 15 minutes post intervention. Will be compared to pre-intervention electroencephalography measures.

Eligibility
Key inclusion criteria
Ages 18-30 years
Right hand dominant
male and female sex
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking neuroactive medications
Do not pass safety screen for contraindications to non-invasive brain stimulation
no consent given
under the influence of alcohol at the time of the experiment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation was performed and it will require the recruitment of 39 healthy adult participants. This power calculation was based on a previous study which used NIBS to induce neglect symptoms in healthy adults (Nyffeler et al. 2009) (effect size d=0.4, 80% power, a = 0.05).
Statistical analysis will be undertaken using SPSS software (IBM Cort., 2016, IBM SPSS Statistics for Windows, Version 24.0, Armonk, NY, USA) and MATLAB 8.1.0 (MathWorks, inc., Natick, MA). The statistical significance level will be set to P < 0.05, and the Shapiro-Wilk test will be used to check the normality of the data. Effects of response bias on the LMT will be compared before and after stimulation with a paired t-test. We will then investigate whether connectivity of the stimulated parietal cortex with the rest of the scalp can predict behavioural change on the LMT following cTBS. This will be achieved using a partial least squares regression analysis (PLS) which will identify a model of connectivity between P4 (seed electrode) and all others to maximally predict variance in the behavioural response to cTBS. PLS regression will be performed using the N-way Toolbox for MATLAB. The dependent variable will be the response bias on the LMT. The independent variable will be connectivity between P4 and all other electrodes. Separate PLS analyses will be performed for different frequency bands (delta, theta, alpha, and beta). Co-variates of age, gender, physical activity (IPAQ), will be added as co-variates to the model. Once the connectivity model predictive of response on the LMT is identified, we will perform a repeated measures ANOVA to determine how connectivity of this model is influenced by cTBS (time points: baseline, post 1, post 2).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
10/05/2019
Actual
Date of last data collection
Anticipated
10/05/2019
Actual
Sample size
Target
39
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 25120 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301420 0
University
Name [1] 301420 0
University of South Australia
Country [1] 301420 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 301098 0
None
Name [1] 301098 0
Address [1] 301098 0
Country [1] 301098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302153 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 302153 0
Ethics committee country [1] 302153 0
Australia
Date submitted for ethics approval [1] 302153 0
22/08/2018
Approval date [1] 302153 0
09/10/2018
Ethics approval number [1] 302153 0
201539

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

Contacts
Principal investigator
Name 89306 0
Miss Jessica Mariner
Address 89306 0
University of South Australia, 108 North Terrace Adelaide, SA 5001
Country 89306 0
Australia
Phone 89306 0
+61 883022097
Fax 89306 0
Email 89306 0
[email protected]
Contact person for public queries
Name 89307 0
Jessica Mariner
Address 89307 0
University of South Australia, 108 North Terrace Adelaide, SA 5001
Country 89307 0
Australia
Phone 89307 0
+61 1300301703
Fax 89307 0
Email 89307 0
[email protected]
Contact person for scientific queries
Name 89308 0
Jessica Mariner
Address 89308 0
University of South Australia, 108 North Terrace Adelaide, SA 5001
Country 89308 0
Australia
Phone 89308 0
+61 1300301703
Fax 89308 0
Email 89308 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
For participant privacy


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.