At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Motor imagery based EEG-BCI (other)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Motor imagery based EEG-BCI — other: 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the University of Ulster, looks at detecting awareness in people with disorders of consciousness or paralysis, including conditions such as motor neuron disease and stroke. Study 1 involves an initial assessment or screening. Study 2 involves training with a brain-computer interface (a device controlled by brain signals) for people found to have awareness in Study 1 or who need movement-independent assistive technology.
Who can take part
- Study 1: People with a disorder of consciousness or low awareness state diagnosis, including vegetative state, minimally conscious state, or locked-in syndrome (for example from motor neuron disease, stroke or other injury or disease)
- Study 1: Acute and post-acute patients where appropriate
- Study 2: People from Study 1 who show signs of awareness based on brain activity, or people already known to have awareness who could benefit from assistive devices controlled by a brain-computer interface
Who may not be able to
- Study 1: People with brain-related diseases or illnesses (such as progressive neurological conditions or uncontrolled epilepsy) or who suffer from pain, if clinical teams judge them unsuitable
- Study 1: People taking medicines that cause excessive tiredness or affect thinking
- Study 1: People whose first language is not English
- Study 1: People with excessive uncontrollable arm or head movement or teeth grinding, as this would spoil the EEG (brain signal) recording
- Study 2: People who showed no active brain responses in Study 1
What taking part involves
- • An initial assessment or screening (Study 1), including tests that record brain activity (EEG)
- • Training to use a brain-computer interface (Study 2)
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 10 Years to 80 Years
- Who
- All
- Number of participants
- 30
- Started
- 2022-02-08
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for disorder of consciousness
- • NA - 30 participants
- • STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees
Who can take part?
- • Ages 10 Years to 80 Years
- • Diagnosed with disorder of consciousness
Where?
- • Warwick - Castel Froma Neuro Care
- • Antrim - Northern Health and Social Care Trust
- • Barnsley - Barnsley Hospital NHS Foundation Trust
- • Belfast - Belfast Health and Social Care Trust
- • +13 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
PRINCIPLE RESEARCH QUESTIONS The project will address a number key principal research questions largely based on two phases to the study. Phase/study 1 1. What percentage of disorder of consciousness patients assessed provide evidence of awareness using EEG-based BCI technology? 2. How does this differ from their clinical diagnosis/prognosis? 3. Does the EEG-based information complement or augment the clinical assessment and diagnosis process? 4. 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 1. 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? 2. 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? 3. 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 1. Does the technology aid feedback/interpretation on assessment outcomes from consultants? 2. How might the experiment provide an opportunity for training others in the deployment of the technology in a clinical setting? 3. What types of BCI methods of feedback are best auditory/visual or both, musical or broadband noise, games or applications etc?
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 10 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓acute, post-acute patients where appropriate
Who cannot take part
- ✗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...
- ✗Study 2 - BCI training
- ✗Inclusion Criteria:
See the full criteria
Where Is This Study? (17 UK sites)
Castel Froma Neuro Care
Warwick CV32 6LL, United Kingdom
Northern Health and Social Care Trust
Antrim BT41 2RL, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley S75 2EP, United Kingdom
Belfast Health and Social Care Trust
Belfast BT9 7AB, United Kingdom
Frenchay Brain Injury Rehabilitation Centre
Bristol BS16 2UU, United Kingdom
NHS Lothian
Edinburgh EH9 2HL, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull HU3 2JZ, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool L9 7LJ, United Kingdom
The Huntercombe Group
London SE10 8AD, United Kingdom
Royal Hospital for Neuro-Disability
London SW15 3SW, United Kingdom
Imperial College Healthcare NHS Trust
London W6 8RF, United Kingdom
Western Health and Social Care Trust
Londonderry BT47 6SB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7HE, United Kingdom
Southern Health and Social Care Trust
Portadown BT63 5QQ, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2JF, United Kingdom
South Warwickshire NHS Foundation Trust
Warwick CV34 5BW, United Kingdom
Inspire Neurocare Worcester
Worcester WR2 6AS, United Kingdom
How to Get in Touch
Damien Coyle, PhD
Sponsor contactCONTACT
Naomi du Bois, PhD
Sponsor contactCONTACT