Condition category
Nervous System Diseases
Date applied
20/11/2020
Date assigned
24/11/2020
Last edited
02/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off.
Over 20M people suffer from stroke annually worldwide and up to 40% of stroke survivors may suffer from permanent upper limb paralysis. Unfortunately, despite undergoing a range of therapeutic treatments, many people with upper limb impairments (arising from a stroke & other nervous system disorders) fail to make full functional recovery adversely affecting their quality of life and employability.
It is possible to control an external robotic device using electrical signals generated from brain activity (known as a brain-robot interface [BRI]).
Magnetoencephalography (MEG) is a functional neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain, using very sensitive magnetometers.
The study aims to look into the connection between brain activity measured using MEG and muscle activity.

Who can participate?
Post-stroke volunteers aged 18 - 80 years, who had a stroke between 6 months and 2 years previously.

What does the study involve?
Experiments will take place in ISRC’s Northern Ireland Functional Brain Mapping (NIFBM) facility where EEG/MEG will be recorded while undertaking physical practice and/or mental practice of left or right-hand movements. This will involve some preparation consisting of attaching a few electrodes and head digitisation following a standard operating procedure. Once ready, participants will wear a robotic exoskeleton on their impaired hand and be seated in an arm-chair in front of a projector or computer screen. Arrows on the screen will guide participants about the hand (either left or right) to be used for performing or imagining the experimental task. A typical experimental task may consist of clenching a soft ball in one of the hands at a time. Thus, participants have to either perform the task or imagine to perform it. During and after the session participants will complete some brief questionnaires.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
Ulster University (UK)

When is the study starting and how long is it expected to run for?
April 2017 to October 2022.

Who is funding the study?
UK-India Education and Research Initiative.

Who is the main contact?
Prof. Girijesh Prasad, g.prasad@ulster.ac.uk

Trial website

https://www.ulster.ac.uk/research/topic/computer-science/intelligent-systems-research-centre/projects

Contact information

Type

Scientific

Primary contact

Prof Girijesh Prasad

ORCID ID

https://orcid.org/0000-0003-3284-9589

Contact details

Intelligent Systems Research Centre
School of Computing
Engineering and Intelligent Systems
Faculty of Computing
Engineering and the Built Environment
Ulster University
Magee campus
Derry-Londonderry
BT48 7JL
United Kingdom
+44 (0)28 71 675645
g.prasad@ulster.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Protocol number 19/0103, IRAS 266827

Study information

Scientific title

M/EEG based Post-stroke Neurorehabilitation with Brain-Robot Interface

Acronym

MEPSeN-BRI

Study hypothesis

1. Evaluate the effectiveness of the BCI algorithms developed in non-disabled adults for people with stroke. Evaluate whether MEG/EEG-EMG based BCI algorithm is able to function correctly under different levels of impairments and MEG/EEG signal variability is appropriately accounted for so that motor tasks detection accuracy does not deteriorate over time. MEG, EEG and EMG will be acquired concurrently
2. Conduct pilot trials over multiple sessions to monitor the effect of learning over time in terms of progression in BCI task detection accuracy as well as functional recovery. Also, analyze EEG and/or MEG data along with rehabilitation outcomes (or recovery measures) to estimate neuro-markers as a relationship between cortical connectivity measures and motor deficits
3. Compare the contributions of different interventions by creating control groups for post-stroke hand functional recovery such as i) Manual Physical Practice without robot, ii) Physical Practice with Robot without BCI, iii) Only BCI based Mental Practice without robot, iv) Combined BCI based Mental and Robot based Physical Practice

Ethics approval

Approved 09/06/2020, Office for Research Ethics Committees Northern Ireland (ORECNI) (Business Services Organisation, Lissue Industrial Estate West, 5 Rathdown Walk, Moira Road, Lisburn, BT28 2RF, UK; +44 (0)28 9536 1400; info.orecni@hscni.net), ref: 20/NI/0034

Study design

Interventional non-randomized

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

See additional file ISRCTN88026375_PIS_v2.0_19May2020 (added 02/12/2020)

Condition

Neurorehabilitation of chronic stroke patients

Intervention

A therapy session normally consists of approximately half an hour of physical (i.e. motor execution (ME)) practice followed by half an hour of motor imagery (MI) practice. This amounts to 4 runs of PP followed by 4 runs of MI practice, each run consisting of 40 trials of approximately 10 seconds duration. Thus each run lasts between 6 and 7 minutes. There will be a resting period of approximately 5 minutes between two consecutive runs. An additional time of up to 1 hour will be required in subject preparation and thus total time required for one session will be about 2.5 hours.

Background:
The project involves development of a robotic hand exoskeleton and MEG/EEG-EMG based BCI algorithms, experimentation over a maximum of twenty sessions for motor execution and/or imagery tasks related MEG/EEG-EMG data acquisition, and extensive performance evaluation with stroke participants on a state-of-the-art BCI system at Northern Ireland Functional Brain Mapping (NIFBM) at Intelligent Systems research Centre(ISRC), Ulster University, Magee campus. Experimental trials are being conducted in two phases. The ethical approval for phase-1 has already been obtained and trials on sixteen healthy and nine stroke participants have been completed and the data analysis is underway. All the three components MEG/EEG-EMG based BCI algorithm, visual neurofeedback, and robotic
exoskeleton have been found to work very satisfactorily on healthy individuals. An experimental session normally consists of approximately half an hour of physical (i.e. motor execution (ME)) practice followed by half an hour of motor imagery (MI) practice. This amounts to 4 runs of PP followed by 4 runs of MI practice, each run consisting of 40 trials of approximately 10 seconds duration. Thus each run lasts between 6 and 7 minutes. There will be a resting period of approximately 5 minutes between two consecutive runs. An additional time of up to 1 hour will be required in subject preparation and thus total time required for one session will be about 2.5 hours. In particular, this phase-2 trial will meet the above three aims in the following ways:
1. Some stroke survivors may have none or very weak EMG activation, while some may suffer from hand spasticity resulting from involuntary excitation of multiple muscles (i.e. EMG). It will be investigated whether the MEG/EEG-EMG based BCI algorithms can effectively account for these issues, while controlling hand exoskeleton motion and providing appropriate neurofeedback for enhancing post-stroke rehabilitation. Neurofeedback will be a visual representation of the task completed.

2. Functional recovery outcomes using Action Research Arm Test (ARAT) and grip strength will be measured on a weekly basis during the trial period. At the same time, functional connectivities among activated brain regions will be computed using activation related MEG/EEG-EMG data. Using these two sets of measures, a correlation between motor deficit and functional connectivity will be established.

3. As part of acceptability and usability study, participants’ mood, motivation, and fatigue level will be continuously monitored using appropriate visual analog scales. To monitor the sustained effect of using the system, mood will also be assessed on a weekly basis, using the Centre for Epidemiologic Studies-Depression Scale.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Functional recovery measured using the Action Research Arm Test (ARAT) and grip strength on a weekly basis during the trial period
2. Functional connectivity among activated brain regions will be computed using activation related MEG/EEG-EMG data on a weekly basis during the trial period

Secondary outcome measures

1. Participants’ mood, motivation, and fatigue level will be continuously monitored during sessions using appropriate visual analog scales
2. Mood will be assessed weekly, using the Centre for Epidemiologic Studies-Depression Scale

Overall trial start date

01/04/2017

Overall trial end date

31/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Post-stroke volunteers aged 18 - 80 years with normal or corrected to normal vision (e.g. normal vision by using glasses)
2. 6 months - 2 years post-stroke since first episode of stroke
3. Able to follow two-part spoken or written commands
4. Have movement disability in at least one of their hands due to stroke
5. Able to get in and out of a low seat unassisted
6. Prepared to remove all body piercings

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Known to have a progressive neurological condition
2. Have metal or active implants in their body (excluding dental fillings or crowns)
3. Known to suffer from claustrophobia
4. Pregnant or breast feeding
5. Gross cognitive impairment or disorientation, evidenced by a Hodgkinson mini-mental test score (HMMS) (Hodgkinson, 1972) of less than 21/30

Recruitment start date

07/10/2020

Recruitment end date

31/10/2021

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Ulster University
Northern Ireland Functional Brain Mapping Facility MS229 Intelligent Systems Research Centre Magee Campus
Derry-Londonderry
BT48 7JL
United Kingdom

Sponsor information

Organisation

University of Ulster

Sponsor details

Jordanstown campus
Belfast
BT37 0QB
United Kingdom
+44 (0)2890366629
n.curry@ulster.ac.uk

Sponsor type

University/education

Website

http://www.ulster.ac.uk/

Funders

Funder type

Government

Funder name

UK-India Education and Research Initiative

Alternative name(s)

UKIERI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The dissemination of the findings is done by publishing the outcomes of the study in various internationally reported scientific journals and conferences.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/10/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

New publications will be provided later.

Publication citations

Additional files

Editorial Notes

02/12/2020: The participant information sheet has been uploaded as an additional file. 23/11/2020: Trial’s existence confirmed by Office for Research Ethics Committees Northern Ireland.