Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001380583
Ethics application status
Approved
Date submitted
15/07/2015
Date registered
17/12/2015
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Brain Computer Interface (BCI) driven Paired Associative Stimulation (PAS) protocol: A rehabilitation intervention for people with stroke.
Scientific title
A Brain Computer Interface (BCI) driven Paired Associative Stimulation (PAS) protocol: An investigation of the effects of a 4-week BCI-PAS intervention on cortical excitability and walking performance in people with stroke.
Secondary ID [1] 286836 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295222 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296037 296037 0 0
Other physical medicine / rehabilitation
Stroke 296120 296120 0 0
Ischaemic
Stroke 296121 296121 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BCI-PAS intervention will be delivered three times per week for 4 weeks.

In the first session of each week, 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 for that week.

The BCI-PAS is delivered three times each week for 4 weeks, by a trained Research Assistant. During each intervention session, the subject completes 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) is delivered to the deep branch of the common peroneal nerve at the intensity required to produce a palpable twitch in the tibialis anterior tendon. Each pulse of electrical stimulation is 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] 291997 0
Rehabilitation
Intervention code [2] 292463 0
Treatment: Devices
Comparator / control treatment
BCI-PAS will be delivered three times per week for four weeks, with a lower intensity of electrical stimulation than that used in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 295195 0
Corticomotor excitability using Transcranial Magnetic Stimulation (TMS).
Timepoint [1] 295195 0
3 days post completion of the 4-week intervention.
Primary outcome [2] 295197 0
3D gait analysis.
Timepoint [2] 295197 0
5 days post completion of the 4-week intervention.
Primary outcome [3] 295707 0
Walking speed (6m walk test)
Timepoint [3] 295707 0
5 days post completion of the 4-week intervention.
12 days post completion of the 4-week intervention.
Secondary outcome [1] 315022 0
Dynamic balance assessed using the Step test.
Timepoint [1] 315022 0
5 days post completion of the 4-week intervention.
12 days post completion of the 4-week intervention.
Secondary outcome [2] 316280 0
Maximum voluntary contraction of the ankle dorsiflexors. Measured with force plate.
Timepoint [2] 316280 0
3 days post completion of the 4-week intervention.
Secondary outcome [3] 316281 0
Interviews to determine acceptability of the intervention to people with stroke.
Timepoint [3] 316281 0
Post intervention.
Secondary outcome [4] 316538 0
Safety monitored by recording any medical/physical changes at the beginning of each session, and any changes during the session. Unrelated events such as illness will be recorded and may result in a session being missed. Possible related events include superficial skin irritation related to electrode placement, or transient effects associated with transcranial magnetic stimulation such as headache, discomfort, hearing changes, or syncope. Risk of seizure related to transcranial magnetic stimulation is considered very low, and subjects at increased risk of seizure are excluded from the study during screening processes. Any adverse events requiring the participant to seek medical attention from a health professional will be recorded on an adverse events form.
Timepoint [4] 316538 0
At the beginning and during each session, throughout the duration of the study.
Secondary outcome [5] 319399 0
Adherence monitored by register of attendance at sessions.
Timepoint [5] 319399 0
Throughout the duration of the study.

Eligibility
Key inclusion criteria
Stroke with hemiparesis affecting ability to walk.
>6 months post stroke.
Gait speed 0.05-1.2m/s.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive, perceptual or communication deficits.
Presence of another medical condition that may impact the results.
Contra-indications to Transcranial Magnetic Stimulation.

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)
Each subject is screened for inclusion in the study. After providing informed written consent at their first session, subjects are randomly allocated via a computer-generated randomisation plan which is held by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated using https://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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Unbiased variance estimates for all outcomes will be produced under identity and log transformation. The sample size should enable reasonably precise estimates of variance in functional outcomes that will be primary outcome candidates for a future trial.

An ANCOVA model will be used to estimate the effect of BCI-PAS on cortical excitability and functional outcomes, adjusting for baseline values. If necessary, logarithmic transformations will be applied to improve the normality of the data. As a pilot, this study will not be powered to detect statistically significant differences between intervention and control groups with high power at a low significance level.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
15/04/2015
Date of last participant enrolment
Anticipated
29/07/2016
Actual
20/01/2016
Date of last data collection
Anticipated
Actual
7/04/2016
Sample size
Target
20
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 6920 0
New Zealand
State/province [1] 6920 0
Auckland

Funding & Sponsors
Funding source category [1] 291383 0
Charities/Societies/Foundations
Name [1] 291383 0
Neurological Foundation of New Zealand
Country [1] 291383 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Physiotherapy New Zealand
Address
PO Box 27 386, Wellington 6141, New Zealand
Country
New Zealand
Secondary sponsor category [1] 290058 0
University
Name [1] 290058 0
Auckland University of Technology
Address [1] 290058 0
Private Bag 92006
Auckland 1142
Country [1] 290058 0
New Zealand
Other collaborator category [1] 278490 0
University
Name [1] 278490 0
Aalborg University
Address [1] 278490 0
P.O. Box 159
DK - 9100 Aalborg
Denmark
Country [1] 278490 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292939 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [1] 292939 0
55 Wellesley Street East, Auckland 1010.
Ethics committee country [1] 292939 0
New Zealand
Date submitted for ethics approval [1] 292939 0
Approval date [1] 292939 0
14/11/2014
Ethics approval number [1] 292939 0

Summary
Brief summary
The aim of this research is to explore the feasibility of the BCI-PAS protocol as an intervention to improve walking performance in people with stroke. This pilot randomised controlled trial will investigate the effect of a 4-week BCI-PAS intervention on cortical excitability and walking performance. The study will provide estimates of variance and effect size for measures of physical function, which will be used to inform a large randomised controlled trial powered for changes in clinical outcomes. Other issues of feasibility will be addressed including safety, adherence and acceptability of the intervention to people with stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57730 0
Prof Denise Taylor
Address 57730 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University, Private Bag 92006,
Auckland 1142.
Country 57730 0
New Zealand
Phone 57730 0
+64 9 921 9680
Fax 57730 0
Email 57730 0
[email protected]
Contact person for public queries
Name 57731 0
Nada Signal
Address 57731 0
Health & Rehabilitation Research Institute, School of Rehabilitation and Occupation Studies, AUT University, Private Bag 92006, Auckland 1142.
Country 57731 0
New Zealand
Phone 57731 0
+64 9 921 9999 x7062
Fax 57731 0
Email 57731 0
[email protected]
Contact person for scientific queries
Name 57732 0
Denise Taylor
Address 57732 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University, Private Bag 92006,
Auckland 1142.
Country 57732 0
New Zealand
Phone 57732 0
+64 9 921 9680
Fax 57732 0
Email 57732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.