Awareness Detection and Communication in Disorders of Consciousness

NCT ID: NCT03827187

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2026-08-31

Brief 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.

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

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?

Conditions

Disorder of Consciousness; Paralysis; Motor Neuron Disease; Stroke; Physical Disability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Motor imagery based EEG-BCI

Intervention Type: 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. 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.

Interventions

Motor imagery based EEG-BCI

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Rehabilitation Hospital, Ireland

UNKNOWN

Sponsor Role: collaborator

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Western Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Southern Health and Social Care Trust

OTHER_GOV

Sponsor Role: collaborator

Northern Health and Social Care Trust

OTHER_GOV

Sponsor Role: collaborator

Barnsley Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

Walton Centre NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Royal Hospital for Neuro-disability

OTHER

Sponsor Role: collaborator

South Warwickshire NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Castel Froma Neuro Care

UNKNOWN

Sponsor Role: collaborator

Inspire Neurocare

UNKNOWN

Sponsor Role: collaborator

The Huntercombe Group

UNKNOWN

Sponsor Role: collaborator

Active Care Group

UNKNOWN

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien Coyle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulster

Locations

National Rehabilitation Hospital of Ireland

Dublin, , Ireland

Site Status: NOT_YET_RECRUITING

Castel Froma Neuro Care

Warwick, Warwickshire, United Kingdom

Site Status: RECRUITING

Northern Health and Social Care Trust

Antrim, , United Kingdom

Site Status: RECRUITING

Barnsley Hospital NHS Foundation Trust

Barnsley, , United Kingdom

Site Status: RECRUITING

Belfast Health and Social Care Trust

Belfast, , United Kingdom

Site Status: RECRUITING

Frenchay Brain Injury Rehabilitation Centre

Bristol, , United Kingdom

Site Status: RECRUITING

NHS Lothian

Edinburgh, , United Kingdom

Site Status: RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, , United Kingdom

Site Status: RECRUITING

The Walton Centre NHS Foundation Trust

Liverpool, , United Kingdom

Site Status: RECRUITING

The Huntercombe Group

London, , United Kingdom

Site Status: RECRUITING

Royal Hospital for Neuro-Disability

London, , United Kingdom

Site Status: RECRUITING

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Western Health and Social Care Trust

Londonderry, , United Kingdom

Site Status: RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status: RECRUITING

Southern Health and Social Care Trust

Portadown, , United Kingdom

Site Status: RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status: RECRUITING

South Warwickshire NHS Foundation Trust

Warwick, , United Kingdom

Site Status: RECRUITING

Inspire Neurocare Worcester

Worcester, , United Kingdom

Site Status: RECRUITING

Countries

Ireland; United Kingdom

Central Contacts

Damien Coyle, PhD

Role: CONTACT

Phone: +44 28 7167 5170

Email: dh.coyle@ulster.ac.uk

Naomi du Bois, PhD

Role: CONTACT

Phone: +44 28 7167 5321

Email: n.du-bois@ulster.ac.uk

Facility Contacts

Dr Valerie Twomey

Role: primary

Elizabeth Jackson

Role: primary

Damon Hoad

Role: backup

Jacqueline Pogue

Role: primary

Simon Judge, MEng

Role: primary

Sheena Caldwell, MB BCh FRCP(UK)

Role: primary

Suzanne Moss

Role: primary

Dr Alasdair Fitzgerald

Role: primary

Abayomi Salawu, MBBS, FWACS, FRCSI, PGCME, MSc

Role: primary

Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM

Role: primary

Samantha Mcantagart

Role: primary

Lloyd Bradley, MD

Role: primary

Dr Paul Bentley

Role: primary

Dr Paul Johnson

Role: primary

Emma Dodds

Role: primary

Dr Bernadette Salisbury

Role: primary

Sivaraman Nair, DM, FRCP

Role: primary

Dr Damon Hoad

Role: primary

Harriet Miller

Role: primary

Damon Hoad

Role: backup

Other Identifiers

136640

Identifier Type: -

Identifier Source: org_study_id