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Trial registered on ANZCTR


Registration number
ACTRN12617000838314
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
7/06/2017
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results information initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The usefulness of a Brain Computer Interface for rehabilitation after stroke.
Scientific title
The effects of Brain Computer Interface-based Paired Associative Stimulation (BCI-PAS) on lower limb strength and fatigue resistance in people with stroke.

Secondary ID [1] 292128 0
Nil known
Universal Trial Number (UTN)
U111111953714
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303534 0
Condition category
Condition code
Stroke 302943 302943 0 0
Ischaemic
Stroke 302944 302944 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 302964 302964 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive a single session of the BCI-PAS intervention, and a single session of a Control intervention, on different days, 7 days apart (in a randomised order). Participants will be blinded to this order.

During a baseline testing session, electroencephalography (EEG) will be recorded using an electrode cap, while subjects perform active ankle dorsiflexion of their affected leg, in time with a visual cue. 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 the BCI-PAS intervention.

The BCI-PAS intervention will be delivered by a trained Research Assistant. During the BCI-PAS intervention, the subject 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. Each pulse of electrical stimulation will be timed to arrive in the motor cortex at the point of peak negativity of the MRCP. The BCI-PAS intervention takes approximately 15 minutes, with additional time required for setting up the electrical stimulation.
Intervention code [1] 298257 0
Rehabilitation
Intervention code [2] 298258 0
Treatment: Other
Intervention code [3] 298290 0
Treatment: Devices
Comparator / control treatment
The control intervention will be carried out in the same way as the BCI-PAS intervention, 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] 302341 0
Maximum voluntary contraction of the ankle dorsiflexors. Measured with force plate.
Timepoint [1] 302341 0
Immediately pre- and immediately post-intervention.
Primary outcome [2] 302342 0
Fatigue resistance of the ankle dorsiflexors. Measured with force plate.
Timepoint [2] 302342 0
Immediately pre- and immediately post-intervention.
Secondary outcome [1] 335598 0
Corticomotor excitability using Transcranial Magnetic Stimulation (TMS).
Timepoint [1] 335598 0
Immediately pre- and immediately post-intervention
Secondary outcome [2] 335599 0
Electromyography of the tibialis anterior muscle during maximum voluntary contraction.
Timepoint [2] 335599 0
Immediately pre- and immediately post-intervention
Secondary outcome [3] 335600 0
Voluntary activation, measured using twitch interpolation applied during voluntary contraction of the dorsiflexor muscles.
Timepoint [3] 335600 0
Immediately pre- and immediately post-intervention
Secondary outcome [4] 370348 0
Rate of force development during the first 200ms of maximum voluntary contraction of the dorsiflexors. Calculated from force data.
Timepoint [4] 370348 0
Immediately pre- and immediately post-intervention
Secondary outcome [5] 370349 0
Time to 90% of maximum voluntary contraction of the dorsiflexors. Calculated from force data.
Timepoint [5] 370349 0
Immediately pre- and immediately post-intervention
Secondary outcome [6] 370350 0
Central fatigue calculated from the change in voluntary activation of tibialis anterior during a fatiguing contraction.
Timepoint [6] 370350 0
Immediately pre- and immediately post-intervention
Secondary outcome [7] 370351 0
Peripheral fatigue calculated from resting muscle twitch before and after fatiguing contraction of tibialis anterior
Timepoint [7] 370351 0
Immediately pre- and immediately post-intervention

Eligibility
Key inclusion criteria
- Single stroke causing hemiparesis, and affecting the ability to move the ankle.
- > 6 months post stroke
Minimum age
18 Years
Maximum age
No limit
Gender
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 the study a randomisation schedule will be generated to determine the order in which each of the 15 participants will receive the intervention and control. This will be held by a third party.
Following consent, each participant will be allocated a number between 1 and 15, 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 a 2-way repeated measures ANOVA, and post hoc t-tests to explore main effects and interactions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8950 0
New Zealand
State/province [1] 8950 0
Auckland

Funding & Sponsors
Funding source category [1] 296647 0
University
Name [1] 296647 0
Auckland University of Technology
Address [1] 296647 0
Private Bag 92006
Auckland 1142
Country [1] 296647 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] 295607 0
None
Name [1] 295607 0
Address [1] 295607 0
Country [1] 295607 0
Other collaborator category [1] 279594 0
University
Name [1] 279594 0
Aalborg University
Address [1] 279594 0
P.O. Box 159
DK - 9100 Aalborg
Country [1] 279594 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297874 0
Health and Disability Ethics Committees
Ethics committee address [1] 297874 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 297874 0
New Zealand
Date submitted for ethics approval [1] 297874 0
28/04/2017
Approval date [1] 297874 0
31/05/2017
Ethics approval number [1] 297874 0
17/NTB/80

Summary
Brief summary
The aim of this research is to investigate whether one session of the Brain Computer Interface-based Paired Associative Stimulation protocol can improve measures of muscle and brain function, more than an attention- and dose-matched control, in people with chronic stroke. The study will use a repeated measures cross-over design, where each participant will receive the treatment and control, 7 days apart, in a randomised order.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75334 0
Prof Denise Taylor
Address 75334 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University, Private Bag 92006, Auckland 1142.
Country 75334 0
New Zealand
Phone 75334 0
+64 9 921 9680
Fax 75334 0
Email 75334 0
denise.taylor@aut.ac.nz
Contact person for public queries
Name 75335 0
Mrs Sharon Olsen
Address 75335 0
Health & Rehabilitation Research Institute, School of Rehabilitation and Occupation Studies, AUT University, Private Bag 92006, Auckland 1142.
Country 75335 0
New Zealand
Phone 75335 0
+64 9 921 9999 x9494
Fax 75335 0
Email 75335 0
solsen@aut.ac.nz
Contact person for scientific queries
Name 75336 0
Mrs Sharon Olsen
Address 75336 0
Health & Rehabilitation Research Institute, School of Rehabilitation and Occupation Studies, AUT University, Private Bag 92006, Auckland 1142.
Country 75336 0
New Zealand
Phone 75336 0
+64 9 921 9999 x9494
Fax 75336 0
Email 75336 0
solsen@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval does not cover sharing of data
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary