Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001313123
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
26/09/2019
Date last updated
26/09/2019
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The optimal delivery of a Brain Computer Interface intervention for people with stroke.
Scientific title
An investigation of the optimal method for delivering a Brain Computer Interface intervention to improve the brain-muscle connection following stroke.
Secondary ID [1] 299195 0
Nil known
Universal Trial Number (UTN)
U1111-1237-8423
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 314295 0
Condition category
Condition code
Stroke 312644 312644 0 0
Ischaemic
Stroke 312645 312645 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 312647 312647 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive three different conditions, two interventions, and one control, on three different days, 7 days apart (in a randomised order). Participants will be blinded to this order.

At the start of each session, electroencephalography (EEG) will be recorded using an EEG cap, while participants perform 50 repetitions of active ankle dorsiflexion of their affected leg, in time with a visual cue. The visual cue is a moving cursor on a computer screen which prompts the participant to prepare and then move their ankle. The EEG is then analysed and the peak negativity of the movement related cortical potential (MRCP) is determined. This timing is then used to inform the timing of one of the interventions.

For the two interventions, the participant will complete 50 repetitions of cued active ankle dorsiflexion of the affected leg. During each repetition of ankle dorsiflexion, a single pulse of electrical stimulation (pulse width 1ms) will be delivered to the deep branch of the common peroneal nerve (via two surface electrodes placed approximately 2-5cm anterior and inferior to the head of the fibula). The intensity of the electrical stimulation will be set to the level required to produce a palpable twitch in the tibialis anterior tendon (device intensity range 0-100mA).

For the first intervention, each pulse of electrical stimulation will be timed to arrive in the motor cortex at the point of peak negativity of the MRCP. This timing is set from the pre-recorded MRCP, and therefore is an 'off-line' version of a Brain Computer Interface (comprised of an EEG recording, a computer analysing the EEG and triggering the stimulator, and an electrical stimulation unit).

For the second intervention, each pulse of electrical stimulation will be timed to arrive in the motor cortex at the time the visual cue is given (to move the affected leg).

The intervention takes approximately 15 minutes, with additional time required for setting up the electrical stimulation. Sessions will be delivered by a trained research assistant. The parameters of intervention delivery and any clinical observations concerning the participants engagement and adherence to the intervention will be recorded on data collections sheets.
Intervention code [1] 315489 0
Rehabilitation
Intervention code [2] 315490 0
Treatment: Other
Intervention code [3] 315491 0
Treatment: Devices
Comparator / control treatment
The third intervention is the control and is carried out in the same way as the Brain Computer Interface interventions, except that the participant will not receive the electrical stimulation (a light on the electrical stimulation unit will flash on and off but no stimulation will be given). Although the control intervention uses sham electrical stimulation, the participant will still be performing active ankle movements in time with a visual cue. Thus the control is active.
Control group
Active

Outcomes
Primary outcome [1] 321295 0
Maximal voluntary contraction of the ankle dorsiflexors. Measured with force gauge.
Timepoint [1] 321295 0
Immediately pre- and immediately post-intervention.
Secondary outcome [1] 374557 0
Corticomuscular coherence of the tibialis anterior muscle. Recorded with simultaneous electroencephalography and electromyography.
Timepoint [1] 374557 0
Immediately pre- and immediately post-intervention.
Secondary outcome [2] 374558 0
Force steadiness of the ankle dorsiflexors. Measured with force gauge.
Timepoint [2] 374558 0
Immediately pre- and immediately post-intervention.
Secondary outcome [3] 374559 0
Electromyography of the tibialis anterior during maximal contraction
Timepoint [3] 374559 0
Immediately pre- and immediately post-intervention.
Secondary outcome [4] 374926 0
Electromyography of the tibialis anterior during submaximal contraction
Timepoint [4] 374926 0
Immediately pre- and immediately post-intervention.

Eligibility
Key inclusion criteria
- Single stroke causing hemiparesis and neuromuscular weakness of the ankle dorsiflexor muscles.
- More than 6 months post stroke.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Complete paralysis of the ankle
- Being unable to engage in the testing due to significant cognitive, perceptual or communication deficits
- Cerebellar stroke
- Another medical condition that may impact safety of the testing or the reliability of the results.

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)
Prior to the study a randomisation schedule will be generated to determine the order in which each of the 25 participants will receive the two interventions and control. This will be held by a third party. Following consent, each participant will be allocated a number between 1 and 25, and then the randomisation schedule will determine the order for that participants number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated using www.random.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data from each outcome measure will be analysed using univariate and multivariate linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
29/06/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 21836 0
New Zealand
State/province [1] 21836 0
Auckland

Funding & Sponsors
Funding source category [1] 303735 0
University
Name [1] 303735 0
Auckland University of Technology
Country [1] 303735 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 303851 0
None
Name [1] 303851 0
Address [1] 303851 0
Country [1] 303851 0
Other collaborator category [1] 280941 0
Other
Name [1] 280941 0
New Zealand College of Chiropractic
Address [1] 280941 0
6 Harrison Road
Mt Wellington
Auckland 1060
Country [1] 280941 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304259 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 304259 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304259 0
New Zealand
Date submitted for ethics approval [1] 304259 0
19/08/2019
Approval date [1] 304259 0
02/09/2019
Ethics approval number [1] 304259 0
19/CEN/149

Summary
Brief summary
This study will investigate the optimal method for delivering a Brain Computer Interface intervention to improve brain activity and the ability to move the affected leg, in people with chronic stroke (>6 months). The aim of this research is to investigate the immediate effects of three different interventions: 1) Brain Computer Interface Intervention using the persons brain activity to time the intervention, 2) Brain Computer Interface Intervention using a visual cue to time the intervention, and 3) Control intervention. The study will use a repeated measures cross-over design, where each participant will receive each of the three interventions on three different days, 7 days apart, in a randomised order. Participants will undergo a number of tests before and after each intervention, to determine the effects of each intervention on brain and muscle activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96318 0
Mrs Sharon Olsen
Address 96318 0
Health and Rehabilitation Research Institute
School of Clinical Sciences
Faculty of Health and Environmental Sciences
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 96318 0
New Zealand
Phone 96318 0
+64 9 921 9999
Fax 96318 0
Email 96318 0
[email protected]
Contact person for public queries
Name 96319 0
Mrs Sharon Olsen
Address 96319 0
Health and Rehabilitation Research Institute
School of Clinical Sciences
Faculty of Health and Environmental Sciences
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 96319 0
New Zealand
Phone 96319 0
+64 9 921 9999
Fax 96319 0
Email 96319 0
[email protected]
Contact person for scientific queries
Name 96320 0
Mrs Sharon Olsen
Address 96320 0
Health and Rehabilitation Research Institute
School of Clinical Sciences
Faculty of Health and Environmental Sciences
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 96320 0
New Zealand
Phone 96320 0
+64 9 921 9999
Fax 96320 0
Email 96320 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
Not included in ethical approval


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.