Awareness Detection and Communication in Disorders of Consciousness

NCT03827187 | Recruiting

• 1 other identifier: 136640
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  ~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.

  3-4 sessions of ~1.5 hours

Secondary Outcomes (4)

• Diagnostic utility of BCI data provided through study completion to clinicians

  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

  ~10 sessions of ~1.5 hours

• Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise,

  ~10 sessions of ~1.5hours

• Changes in performance accuracy as a results of time of day of research experimentation

  ~10 sessions of ~1.5hours

Study Arms (1)

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.

Other: Motor imagery based EEG-BCI

Interventions

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. 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.

Motor imagery based Brain computer interfacing

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \- 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.
• \- Participants who have shown no active brain responses in study 1 where the difference between baseline

Sponsors & Collaborators

• University of Ulster: lead
• National Rehabilitation Hospital, Dublin, Ireland (NRH): collaborator
• Belfast Health and Social Care Trust: collaborator
• Western Health and Social Care Trust: collaborator
• Southern Health and Social Care Trust: collaborator
• Northern Health and Social Care Trust: collaborator
• Barnsley Hospital NHS Foundation Trust: collaborator
• NHS Lothian: collaborator
• Walton Centre NHS Foundation Trust: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Royal Hospital for Neuro-disability: collaborator
• South Warwickshire NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Castel Froma Neuro Care: collaborator
• Inspire Neurocare: collaborator
• The Huntercombe Group: collaborator
• Active Care Group: collaborator

Study Sites (18)

National Rehabilitation Hospital of Ireland

Dublin, A96 E2H2, Ireland

NOT YET RECRUITING

Castel Froma Neuro Care

Warwick, Warwickshire, CV32 6LL, United Kingdom

RECRUITING

Northern Health and Social Care Trust

Antrim, BT41 2RL, United Kingdom

RECRUITING

Barnsley Hospital NHS Foundation Trust

Barnsley, S75 2EP, United Kingdom

RECRUITING

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

RECRUITING

Frenchay Brain Injury Rehabilitation Centre

Bristol, BS16 2UU, United Kingdom

RECRUITING

NHS Lothian

Edinburgh, EH9 2HL, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

RECRUITING

The Huntercombe Group

London, SE10 8AD, United Kingdom

RECRUITING

Royal Hospital for Neuro-Disability

London, SW15 3SW, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

RECRUITING

Western Health and Social Care Trust

Londonderry, BT47 6SB, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7HE, United Kingdom

RECRUITING

Southern Health and Social Care Trust

Portadown, BT63 5QQ, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

RECRUITING

South Warwickshire NHS Foundation Trust

Warwick, CV34 5BW, United Kingdom

RECRUITING

Inspire Neurocare Worcester

Worcester, WR2 6AS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Paralysis; Motor Neuron Disease; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neurodegenerative Diseases; Neuromuscular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Damien Coyle, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien Coyle, PhD

CONTACT

+44 28 7167 5170; dh.coyle@ulster.ac.uk

Naomi du Bois, PhD

CONTACT

+44 28 7167 5321; n.du-bois@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: February 1, 2019
• Study Start: February 8, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-11

Locations

IE (1); GB (17)