Disorder of ConsciousnessNCT03827187
Awareness Detection and Communication in Disorders of Consciousness
A study testing Motor imagery based EEG-BCI in people with Disorder of Consciousness and Paralysis, run by University of Ulster at 18 sites in 2 countries.
Trial summary
STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Disorder of Consciousness, Paralysis, Motor Neuron Disease
- What is being tested?
- Motor imagery based EEG-BCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 8 Feb 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome / completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.
- acute, post-acute patients where appropriate
- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and/or those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.
Who cannot join
- Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.
- Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning
- Where English is not the individual's first language
- Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.
- Study 2 - BCI training
- Participants who have shown no active brain responses in study 1 where the difference between baseline
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United Kingdom17 sites, 17 recruiting
- Recruiting
Northern Health and Social Care Trust
Antrim, BT41 2RL
Jacqueline Pogue, jacqueline.pogue@northerntrust.hscni.net
- Recruiting
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
Simon Judge, MEng, simon.judge@nhs.net
- Recruiting
Belfast Health and Social Care Trust
Belfast, BT9 7AB
Sheena Caldwell, MB BCh FRCP(UK), sheena.caldwell@belfasttrust.hscni.net
- Recruiting
Frenchay Brain Injury Rehabilitation Centre
Bristol, BS16 2UU
Suzanne Moss, Suzanne.Moss@huntercombe.com
- Recruiting
NHS Lothian
Edinburgh, EH9 2HL
Dr Alasdair Fitzgerald, alasdair.fitzgerald@nhslothian.scot.nhs.uk
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Abayomi Salawu, MBBS, FWACS, FRCSI, PGCME, MSc, abayomi.salawu@nhs.net
- Recruiting
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM, 07816 078 294 ext. +44, ganesh.bavikatte@thewaltoncentre.nhs.uk
Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM
- Recruiting
The Huntercombe Group
London, SE10 8AD
Samantha Mcantagart, samantha.mcantagart@huntercombe.com
- Recruiting
Royal Hospital for Neuro-Disability
London, SW15 3SW
Lloyd Bradley, MD, lbradley@rhn.org.uk
- Recruiting
Imperial College Healthcare NHS Trust
London, W6 8RF
Dr Paul Bentley, p.bentley@imperial.ac.uk
- Recruiting
Western Health and Social Care Trust
Londonderry, BT47 6SB
Dr Paul Johnson, paul.johnson@westerntrust.hscni.net
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7HE
Emma Dodds, Emma.Dodds@ouh.nhs.uk
- Recruiting
Southern Health and Social Care Trust
Portadown, BT63 5QQ
Dr Bernadette Salisbury, Bernadette.Salisbury@southerntrust.hscni.ne
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Sivaraman Nair, DM, FRCP, siva.nair@nhs.net
- Recruiting
Castel Froma Neuro Care
Warwick, Warwickshire, CV32 6LL
Elizabeth Jackson, elizabeth.jackson@castelfroma.org.uk
Damon Hoad, Damon.Hoad@warwick.ac.uk
- Recruiting
South Warwickshire NHS Foundation Trust
Warwick, CV34 5BW
Dr Damon Hoad, Damon.Hoad@swft.nhs.uk
- Recruiting
Inspire Neurocare Worcester
Worcester, WR2 6AS
Harriet Miller, Worcester.CL@inspireneurocare.co.uk
Damon Hoad, Damon.Hoad@warwick.ac.uk
Ireland1 site, 1 recruiting
- Not yet recruiting
National Rehabilitation Hospital of Ireland
Dublin, A96 E2H2
Dr Valerie Twomey, Valerie.Twomey@nrh.ie
About this study
Official title: EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability
STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.
Read the detailed description
PRINCIPLE RESEARCH QUESTIONS The project will address a number key principal research questions largely based on two phases to the study.
Phase/study 1
- What percentage of disorder of consciousness patients assessed provide evidence of awareness using EEG-based BCI technology?
- How does this differ from their clinical diagnosis/prognosis?
- Does the EEG-based information complement or augment the clinical assessment and diagnosis process?
- Do any of those participants who are diagnosed as being in a vegetative state (or MCS) show signs of awareness beyond the vegetative state based on the EEG-based detection of awareness protocol?
Phase/study 2
- Is it possible to train those participants who show clear signs of awareness, as indicated by significant brain activation during the initial assessment in study 1, to produce a more prominent and/or consistent response over a number of training sessions using BCI based training and feedback protocols?
- Can a subset of the participants use BCI technology to communicate simple responses to questions at the end of the study or is there enough evidence to suggest that with further training over a longer period that the participant may use BCI technology as an alternative or an exclusive communication channel?
- Does neurotechnology offer any other therapeutic benefits to patients, for example, a means of technology interaction that is movement independent and engaging brain areas otherwise not engaged?
SECONDARY RESEARCH Q UESTIONS
- Does the technology aid feedback/interpretation on assessment outcomes from consultants?
- How might the experiment provide an opportunity for training others in the deployment of the technology in a clinical setting?
- What types of BCI methods of feedback are best auditory/visual or both, musical or broadband noise, games or applications etc?
- Being tested
- Motor imagery based EEG-BCI
- Medical subject headings
- Consciousness Disorders, Paralysis, Motor Neuron Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery based EEG-BCIOther
Information gathered in this study may be useful when considering diagnosis of prolonged disorder of consciousness and successful adoption of device could lead to assistive communication intervention with therapeutic benefits. Participants undergo quick assessment to test ability to engage in task, if successful this implies they are minimally conscious, have some awareness of self and memory intact to remember commands. During training participant undergoes multiple sessions whereby they are conducting two different imagined movements to move a sound across the azimuthal plane in a direction dictated by an auditory cue. Participant will receive auditory feedback on the position of the sound which acts as a reflection of how well the participant is engaged in the task in terms of performance and consistency across trials. The participant will move on to use the imagined movements to answer a series of biographical, situational, basic logic and numbers/letters questions.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery based Brain computer interfacing | Experimental | Brief assessment of motor imagery in response to command, auditory feedback training and responding to binary yes-no closed questions through Electroencephalography based Brain-computer interfacing. Receives: Other: Motor imagery based EEG-BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance accuracy of BCI use pre- and post- training
The main primary outcome measure is BCI performance (e.g., accuracy in % for repeated binary choice selections using the BCI e.g., movement free control of cursor towards one of two targets using EEG-based BCI or accuracy in discriminating different brain responses associated with imagined movement of different limbs.
Multiple cross validation will be performed to assess the significance of the difference between a baseline accuracy (pre cue- where accuracy in the response is expected to be around 50% (chance level)) and the peak accuracy (where the accuracy of discriminating event related brain response peaks following the cue).
Measured: ~10 sessions of ~1.5 hours
Change in ability to use imagined movements to consistently communicate yes-no responses to closed questions over multiple sessions by participant with Prolonged Disorder of Consciousness
Accuracy rate when using the BCI system to provide known responses to statements will be used to build evidence to establish that participants could use the technology as an aided communication method. Examples of questions are given below.
Yes Questions:
Your name is David. You are 25 years old.
Measured: 3-4 sessions of ~1.5 hours
Secondary outcomes (4)
Diagnostic utility of BCI data provided through study completion to clinicians
The performance accuracy of the participant in producing consistent cue- induced imagined movements appropriately in timed paradigms will be assessed across sessions, to determine variability and consistency in performance accuracy. The affects of real-time feedback will be looked at, alongside differences in performance accuracy across question subcategories. Performance accuracy per question subcategory will be assessed to evaluate awareness of self versus awareness of environment and understanding of numbers and letters, and logic.
Whether this information is in line with the patient's current diagnosis/CRS-R and WHIM scores will be assessed in order to further understand whether the technology can aid feedback/interpretation on assessment outcomes from consultants?
Measured: 2 - 7 weeks. Duration of study which lasts 10 sessions of ~1.5 hours in addition to some time for analysis/reporting of results
Changes in Wessex Head Injury Matrix and Coma Recovery Scale Scores due to potential therapeutic benefit of engaging in motor imagery
Is there a benefit to intentionally modulating motor cortex regions in response to a command in a timed paradigm over multiple sessions. In participants with a Prolonged Disorder of Consciousness the scores for The Wessex Head Injury Matrix and Coma-Recovery Scale Revised taken at each session will be looked at to seek out therapeutic benefit. Here therapeutic benefit is defined in terms of changes in state of arousal and awareness of self/environment. Therapeutic benefit may also be assessed via performance given as an accuracy percentage of motor imagery trials successfully completed, and how this changes over time.
Measured: ~10 sessions of ~1.5 hours
Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise,
Is there a significant difference in performance as a function of type of feedback participant was receiving - music clips or broadband noise.
Measured: ~10 sessions of ~1.5hours
Changes in performance accuracy as a results of time of day of research experimentation
Arousability varies with time of day - is this reflected in BCI use performance or do some patients perform more optimally at a particular time? The aim is to perform 5 sessions in the morning and 5 in the afternoon to look at the affects of time of day.
Measured: ~10 sessions of ~1.5hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start8 Feb 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- National Rehabilitation Hospital, Dublin, Ireland (NRH), Belfast Health and Social Care Trust, Western Health and Social Care Trust, Southern Health and Social Care Trust, Northern Health and Social Care Trust, Barnsley Hospital NHS Foundation Trust, NHS Lothian, Walton Centre NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, Imperial College Healthcare NHS Trust, Royal Hospital for Neuro-disability, South Warwickshire NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, Castel Froma Neuro Care, Inspire Neurocare, The Huntercombe Group, Active Care Group
- Responsible party
- Sponsor
- Investigators
- Damien Coyle, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827187
- Sponsor's protocol ID
- 136640
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2018
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
du Bois N, Korik A, Hodge S, Hudson L, Elahi AS, Bigirimana A, Dayan N, Sanchez-Bornot JM, McCann A, Yelden K, Bradley L, Nair KPS, Judge S, Hoad D, Vines E, Harilal V, Parke S, Johnson P, Pogue J, Dodds E, Salawu A, Carson R, McCreadie K, Stow J, McElligott J, Carroll A, Coyle D. Advancing EEG-based assessment of consciousness and cognition in prolonged disorders of consciousness. Commun Med (Lond). 2026 Apr 17;6(1):344. doi: 10.1038/s43856-026-01574-x.
PubMed 41998183
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability
- ClinicalTrials.gov ID
- NCT03827187
- Acronym / sponsor ID
- 136640
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- National Rehabilitation Hospital, Dublin, Ireland (NRH), Belfast Health and Social Care Trust, Western Health and Social Care Trust, Southern Health and Social Care Trust, Northern Health and Social Care Trust, Barnsley Hospital NHS Foundation Trust, NHS Lothian, Walton Centre NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, Imperial College Healthcare NHS Trust, Royal Hospital for Neuro-disability, South Warwickshire NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, Castel Froma Neuro Care, Inspire Neurocare, The Huntercombe Group, Active Care Group
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.
Detailed description
PRINCIPLE RESEARCH QUESTIONS The project will address a number key principal research questions largely based on two phases to the study.
Phase/study 1
- What percentage of disorder of consciousness patients assessed provide evidence of awareness using EEG-based BCI technology?
- How does this differ from their clinical diagnosis/prognosis?
- Does the EEG-based information complement or augment the clinical assessment and diagnosis process?
- Do any of those participants who are diagnosed as being in a vegetative state (or MCS) show signs of awareness beyond the vegetative state based on the EEG-based detection of awareness protocol?
Phase/study 2
- Is it possible to train those participants who show clear signs of awareness, as indicated by significant brain activation during the initial assessment in study 1, to produce a more prominent and/or consistent response over a number of training sessions using BCI based training and feedback protocols?
- Can a subset of the participants use BCI technology to communicate simple responses to questions at the end of the study or is there enough evidence to suggest that with further training over a longer period that the participant may use BCI technology as an alternative or an exclusive communication channel?
- Does neurotechnology offer any other therapeutic benefits to patients, for example, a means of technology interaction that is movement independent and engaging brain areas otherwise not engaged?
SECONDARY RESEARCH Q UESTIONS
- Does the technology aid feedback/interpretation on assessment outcomes from consultants?
- How might the experiment provide an opportunity for training others in the deployment of the technology in a clinical setting?
- What types of BCI methods of feedback are best auditory/visual or both, musical or broadband noise, games or applications etc?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor imagery based Brain computer interfacing | Experimental | Other: Motor imagery based EEG-BCIBrief assessment of motor imagery in response to command, auditory feedback training and responding to binary yes-no closed questions through Electroencephalography based Brain-computer interfacing. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome / completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.
- acute, post-acute patients where appropriate
- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and/or those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.
Key exclusion criteria (6 listed)
- Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.
- Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning
- Where English is not the individual's first language
- Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.
- Study 2 - BCI training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imagery based EEG-BCIInformation gathered in this study may be useful when considering diagnosis of prolonged disorder of consciousness and successful adoption of device could lead to assistive communication intervention with therapeutic benefits. Participants undergo quick assessment to test ability to engage in task, if successful this implies they are minimally conscious, have some awareness of self and memory intact to remember commands. During training participant undergoes multiple sessions whereby they are conducting two different imagined movements to move a sound across the azimuthal plane in a direction dictated by an auditory cue. Participant will receive auditory feedback on the position of the sound which acts as a reflection of how well the participant is engaged in the task in terms of performance and consistency across trials. The participant will move on to use the imagined movements to answer a series of biographical, situational, basic logic and numbers/letters questions. | Other | Motor imagery based Brain computer interfacing |
Primary outcome
Change in performance accuracy of BCI use pre- and post- training
Time frame: ~10 sessions of ~1.5 hours
The main primary outcome measure is BCI performance (e.g., accuracy in % for repeated binary choice selections using the BCI e.g., movement free control of cursor towards one of two targets using EEG-based BCI or accuracy in discriminating different brain responses associated with imagined movement of different limbs. Multiple cross validation will be performed to assess the significance of the difference between a baseline accuracy (pre cue- where accuracy in the response is expected to be around 50% (chance level)) and the peak accuracy (where the accuracy of discriminating event related brain response peaks following the cue).
Change in ability to use imagined movements to consistently communicate yes-no responses to closed questions over multiple sessions by participant with Prolonged Disorder of Consciousness
Time frame: 3-4 sessions of ~1.5 hours
Accuracy rate when using the BCI system to provide known responses to statements will be used to build evidence to establish that participants could use the technology as an aided communication method. Examples of questions are given below. Yes Questions: Your name is David. You are 25 years old.
4 secondary outcomes
Diagnostic utility of BCI data provided through study completion to clinicians
Time frame: 2 - 7 weeks. Duration of study which lasts 10 sessions of ~1.5 hours in addition to some time for analysis/reporting of results
Changes in Wessex Head Injury Matrix and Coma Recovery Scale Scores due to potential therapeutic benefit of engaging in motor imagery
Time frame: ~10 sessions of ~1.5 hours
Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise,
Time frame: ~10 sessions of ~1.5hours
Changes in performance accuracy as a results of time of day of research experimentation
Time frame: ~10 sessions of ~1.5hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 41998183du Bois N, Korik A, Hodge S, Hudson L, Elahi AS, Bigirimana A, Dayan N, Sanchez-Bornot JM, McCann A, Yelden K, Bradley L, Nair KPS, Judge S, Hoad D, Vines E, Harilal V, Parke S, Johnson P, Pogue J, Dodds E, Salawu A, Carson R, McCreadie K, Stow J, McElligott J, Carroll A, Coyle D. Advancing EEG-based assessment of consciousness and cognition in prolonged disorders of consciousness. Commun Med (Lond). 2026 Apr 17;6(1):344. doi: 10.1038/s43856-026-01574-x.
- Individual participant dataSharing planned: Undecided
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien Coyle, PhD principal investigator
University of Ulster
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery based EEG-BCI in people with Disorder of Consciousness and Paralysis, run by University of Ulster at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien Coyle, PhD (+44 28 7167 5170, dh.coyle@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance accuracy of BCI use pre- and post- training (time frame: ~10 sessions of ~1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.