EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 (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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
National Rehabilitation Hospital of Ireland
NOT_YET_RECRUITING
Dublin
United Kingdom
Northern Health and Social Care Trust
RECRUITING
Antrim
Barnsley Hospital NHS Foundation Trust
RECRUITING
Barnsley
Belfast Health and Social Care Trust
RECRUITING
Belfast
Frenchay Brain Injury Rehabilitation Centre
RECRUITING
Bristol
NHS Lothian
RECRUITING
Edinburgh
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
The Walton Centre NHS Foundation Trust
RECRUITING
Liverpool
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Hospital for Neuro-Disability
RECRUITING
London
The Huntercombe Group
RECRUITING
London
Western Health and Social Care Trust
RECRUITING
Londonderry
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Southern Health and Social Care Trust
RECRUITING
Portadown
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Castel Froma Neuro Care
RECRUITING
Warwick
South Warwickshire NHS Foundation Trust
RECRUITING
Warwick
Inspire Neurocare Worcester
RECRUITING
Worcester
Contact Information
Primary
Damien Coyle, PhD
dh.coyle@ulster.ac.uk
+44 28 7167 5170
Backup
Naomi du Bois, PhD
n.du-bois@ulster.ac.uk
+44 28 7167 5321
Time Frame
Start Date: 2022-02-08
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
Experimental: Motor imagery based Brain computer interfacing
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.
Related Therapeutic Areas
Sponsors
Collaborators: Active Care Group, Inspire Neurocare, Sheffield Teaching Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Oxford University Hospitals NHS Trust, National Rehabilitation Hospital, Ireland, Barnsley Hospital NHS Foundation Trust, The Huntercombe Group, Northern Health and Social Care Trust, Hull University Teaching Hospitals NHS Trust, South Warwickshire NHS Foundation Trust, Imperial College Healthcare NHS Trust, Southern Health and Social Care Trust, Walton Centre NHS Foundation Trust, NHS Lothian, Western Health and Social Care Trust, Castel Froma Neuro Care, Royal Hospital for Neuro-disability
Leads: University of Ulster

This content was sourced from clinicaltrials.gov