Post-stroke hand rehabilitation with MEG-based brain-robot interface
| ISRCTN | ISRCTN88026375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88026375 |
| IRAS number | 266827 |
| Secondary identifying numbers | Protocol number 19/0103, IRAS 266827 |
- Submission date
- 20/11/2020
- Registration date
- 24/11/2020
- Last edited
- 13/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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 armchair 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 softball 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?
Benefits include the validation of a novel post-stroke rehabilitation therapy capable of motor recovery from chronic upper limb impairments. There are no expected risks.
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 December 2026
Who is funding the study?
UK-India Education and Research Initiative
Ulster University (UK)
Who is the main contact?
Prof. Girijesh Prasad, g.prasad@ulster.ac.uk
Contact information
Scientific
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
 ORCID ID |
0000-0003-3284-9589 |
|---|---|
| Phone | +44 (0)28 71 675645 |
| g.prasad@ulster.ac.uk |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | ISRCTN88026375_PIS_v2.0_19May2020.pdf |
| Scientific title | M/EEG based Post-stroke Neurorehabilitation with Brain-Robot Interface |
| Study acronym | MEPSeN-BRI |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 levels will be continuously monitored during sessions using appropriate methods including visual analog scales 2. Mood will be assessed weekly, using the Centre for Epidemiologic Studies-Depression Scale |
| Overall study start date | 01/04/2017 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/10/2020 |
| Date of final enrolment | 31/10/2026 |
Locations
Countries of recruitment
- Ireland
- Northern Ireland
- United Kingdom
Study participating centre
MS229
Intelligent Systems Research Centre
Magee Campus
Derry-Londonderry
BT48 7JL
United Kingdom
Sponsor information
University/education
Jordanstown campus
Belfast
BT37 0QB
Northern Ireland
United Kingdom
| Phone | +44 (0)2890366629 |
|---|---|
| n.curry@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/ |
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- UKIERI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.0 | 19/05/2020 | 02/12/2020 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN88026375_PIS_v2.0_19May2020.pdf
- Uploaded 02/12/2020
Editorial Notes
13/12/2024: The following changes have been made:
1. Healthy volunteer was added as a participant type.
2. The recruitment end date was changed from 31/10/2021 to 31/10/2026.
3. The overall study end date was changed from 31/12/2024 to 31/12/2026.
4. A benefits and risks statement was added to the plain English summary.
5. The intention to publish date was changed from 31/12/2025 to 31/12/2027.
05/10/2023: The following changes have been made:
1. The overall study end date has been changed from 31/10/2023 to 31/12/2024 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/12/2023 to 31/12/2025.
07/04/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/10/2022 to 31/10/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/10/2021 to 31/12/2023.
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.
