Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001333202
Ethics application status
Approved
Date submitted
28/02/2018
Date registered
8/08/2018
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of afferent feedback in a brain-computer interface (BCI) system in a healthy population
Scientific title
The effects of afferent feedback in a brain-computer interface (BCI) system in a healthy population using transcranial magnetic stimulation (TMS) and coherence measures
Secondary ID [1] 294167 0
NIL
Universal Trial Number (UTN)
U1111-1209-9274
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 306798 0
Condition category
Condition code
Neurological 305905 305905 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A summary of two subprojects
Both subprojects have a different number of sessions. In the first subproject, there are three sessions. For subproject 2, there are two sessions.
a)In Subproject 1, we will Investigate the effect of the type of sensory feedback that a patient receives from assistive technologies (functional electrical stimulation and mechanical robot stimulation) on the communication between the brain and muscles. In this subproject, functional electrical stimulation, mechanical stimulation and joint electrical and mechanical stimulations will be triggered in three separate experimental sessions with at least 24 hours gap. The neuroplastic changes in the nervous system (communication between the brain and muscles) will be quantified by taking the difference between the cerebral and muscular activation before and after each experimental session using TMS. Although this subproject will be evaluated with healthy volunteers, the prospect is to apply the optimal (regarding induction of plasticity) type of sensory feedback in stroke patients with motor impairments.
b)In Subproject 2, we will compare techniques for assessing the communication between the brain and muscles and how they relate to each other. This will be performed in two experimental sessions where coherence measures are recorded pre- and post-intervention in one session and TMS is used pre- and post-intervention in the other session to quantify potential changes with at least 24 hours gap. This project will thus compare the outcome of coherence measures with TMS (gold standard). We hypothesize that coherence will effectively assess neuroplastic changes after BCI intervention. In this scenario, it would be possible to assess the effect of rehabilitation without any risk or discomfort for the patient, and the evaluation could potentially be performed to give the clinicians and patients an indication of the progress/effect of the training. Moreover, this could also improve further research within the area of rehabilitation of stroke patients.
BCI intervention: a single electrical/mechanical stimulation of the common peroneal nerve or tibial nerve will be delivered in conjunction with a variety of motor tasks (they will be asked to imagine or execute the feeling of a lower limb muscle contracting) or a movement task.

Following measures will be used to investigate the hypotheses that are the focus of this project
a). Transcranial Magnetic Stimulation (TMS):
TMS involves magnetic stimulation of areas of the brain that control motor activity and pathways. This allows us to gauge the state of the excitability of the pathways involved. It has been routinely used in neurophysiological research studies for the past 20 years and is also used in clinical practice. A TMS assessment involves applying consistent magnetic stimuli to the brain and recording EMG activity from the targeted muscle. The level of activity in the muscle will change based on the level of excitability in the nervous system. We will assess whether the level of excitability changes pre and post the different interventions that we will be applying based on the EMG recordings of the target muscle. TMS is considered to be safe when proper guidelines and safety checklists are adhered to. We will be following standard best practice procedures when making TMS recordings and will be using the safety checklist.
For quantification of cortical excitability, 15 stimuli with 120% of the motor threshold will be delivered to participants pre, post and post30 minutes for three sessions of subproject 1 and session 1 of Subproject2. TMS will be administered by pacing the TMS coil over the motor cortex to deliver the TMS magnetic pulse by trained staff. PI of the application has experience of using TMS for around ten years. Other team members have varying length of experience of administering the TMS in research setup ranging from 1- 5 years.

b)Evoked potentials (EP)/EEG:
Evoked potentials (EPs) rely on recording brain activity (using EEG) in combination with a task, in this case, dorsiflexion of the foot. In particular, different electrical potentials occur at different times in the brain depending on what tasks, pathways and recording sites are involved. The electrical strength of these peaks can vary based on brain activity. All evoked potential recording electrodes will be placed according to the International Federation of Clinical Neurophysiologists (IFCN) recommendations and our own experience or others in the literature.
c)surface EMG :
Surface EMG will be used to record muscle activity in the lower limb tibialis anterior (TA) when the participant is performing motor tasks (holding a small contraction). Surface EMG will be recorded by placing an electrode over the TA muscle using standard EMG placement and recording techniques. There are no safety issues associated with recording surface EMG.

Participant Involvement: For all the sessions in subproject 1 and 2, we need time commitment from participants. They will be asked to perform ankle movements while EEG and EMG activity being recorded. EEG activity during ankle movement intention will be utilized to activate one of the three methods,1) electrical stimulation of the common peroneal nerve,2) mechanical stimulation and 3) combination of 1 and 2 for subproject ones three sessions. TMS at 120 % of the resting threshold will be used to assess the corticomotor excitability at pre, post and post 30 minutes after the intervention in 3 sessions of subproject 1. During two sessions of the subproject 2 (which will start once subproject one is finished) best feedback mode decided in subproject one will be used, but for assessment in TMS and EMG-EEG coherence in separate sessions at pre, post and post 30 minutes after the intervention.

Throughout the project, the random sample of subjects will be interviewed to see what happened in the session to monitor the adherence and fidelity to the intervention.
Intervention code [1] 300463 0
Treatment: Other
Comparator / control treatment
For subproject One, Effect of using electrical stimulation in the BCI system will be compared to using a mechanical stimulation only of ankle and the combined effect of electrical plus mechanical stimulation. Mechanical stimulation will be provided for passive dorsiflexion ankle movement was delivered through a custom-made motorized orthotic device based on the design of an ergometer.
For subproject two, there is no control.
Control group
Active

Outcomes
Primary outcome [1] 304947 0
The primary outcome will be motor evoked potential elicited by TMS.
Timepoint [1] 304947 0
The primary outcome will be measured Immediately pre-session, immediately post-session, and 30 minutes post-session
Secondary outcome [1] 343682 0
We are going to assess any change in the different frequency bands in different brain parts that are recorded using EEG amplifier having 64 channel.
Timepoint [1] 343682 0
The secondary outcome will also be measured Immediately pre-session, immediately post-session, and 30 minutes post-session.
Secondary outcome [2] 350407 0
As a secondary outcome, from recorded brain signals (EEG) we will also analyse how different parts of the brain are communicating with each other.
Timepoint [2] 350407 0
The secondary outcome will also be measured Immediately pre-session, immediately post-session, and 30 minutes post-session.
Secondary outcome [3] 350444 0
As a secondary outcome, from recorded brain signals (EEG) we will also analyse how the communication strength. of different parts of the brain is effected.
Timepoint [3] 350444 0
The secondary outcome will also be measured Immediately pre-session, immediately post-session, and 30 minutes post-session.

Eligibility
Key inclusion criteria
Up to 45 participants will be recruited from the New Zealand College of Chiropractic community to participate in this study. In case, some participants cannot finish the experiments for some unforeseeable circumstances. At the end, we need 30 participants to finish the experiments.
Participants may include students, staff, faculty, and previous patients of the College’s chiropractic centre. Subjects will be eligible for inclusion if they are English speaking, aged 18-50,
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded from this study, if they have any family history of epilepsy as it is a contraindication for the use of TMS.

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



The people analysing the results/data
Intervention assignment
Crossover
Other design features
To address our hypotheses we will use a single group, quasi-experimental study design. Each group will attend three study sessions and act as their own controls in a cross-over experimental design. The groups’ data will be compared to each other. The order of which intervention they receive will be randomized.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the effects of Brain computer interfaces on the dependent variables a multifactorial repeated measures ANOVA will be used for each of the dependent measures (TMS/Coherence), with “TIME” (pre, post and post 30 intervention measures) and INTERVENTION (BCI with electrical stim/BCI with Mechanical stim/BCI with Electrical and Mechanical stim together) as factors. A priori pairwise comparisons of the pre and post intervention data will be carried out when an interactive effect is significant. All statistical analysis will be carried out using IBM SPSS Statistics Version 21.0.0.0 software (IBM Corp, Armonk, NY). Significance will be set at P = .05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
45
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 9631 0
New Zealand
State/province [1] 9631 0

Funding & Sponsors
Funding source category [1] 298802 0
Other
Name [1] 298802 0
New Zealand College of Chiropractic
Country [1] 298802 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mt. Wellington
Auckland
1060
Country
New Zealand
Secondary sponsor category [1] 297993 0
None
Name [1] 297993 0
None
Address [1] 297993 0
None
Country [1] 297993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299748 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 299748 0
Ethics committee country [1] 299748 0
New Zealand
Date submitted for ethics approval [1] 299748 0
13/12/2017
Approval date [1] 299748 0
21/02/2018
Ethics approval number [1] 299748 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2897 2897 0 0
/AnzctrAttachments/374597(v18-07-2018-13-52-19)-Flowchart v2.pdf (Protocol)

Contacts
Principal investigator
Name 81446 0
Dr Imran Niazi
Address 81446 0
New Zealand College of Chiropractic
PO Box 113­044
Newmarket
1149
Country 81446 0
New Zealand
Phone 81446 0
+64 9 5266789
Fax 81446 0
Email 81446 0
[email protected]
Contact person for public queries
Name 81447 0
Melanie Freiwald
Address 81447 0
New Zealand College of Chiropractic
PO Box 113­044
Newmarket
1149
Country 81447 0
New Zealand
Phone 81447 0
+64 9 5266789
Fax 81447 0
Email 81447 0
[email protected]
Contact person for scientific queries
Name 81448 0
Imran Niazi
Address 81448 0
New Zealand College of Chiropractic
PO Box 113­044
Newmarket
1149
Country 81448 0
New Zealand
Phone 81448 0
+64 9 5266789
Fax 81448 0
Email 81448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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