Study Purpose:
STUDY OVERVIEW Severely altered consciousness most often occurs as a result of brain injury. Some injuries are mild and may cause relatively minor changes in consciousness however a condition may arise where a person is considered to be in a vegetative state, where they are "awake" but unaware. Up to 43% of patients with vegetative state diagnosis are reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all in vegetative state (VS) are incapable of providing any overt motor responses and therefore, in some cases, existing consciousness scales are not wholly sufficient for assessment. There is evidence that a subset of patients with these prolonged disorders of consciousness (DoC) can, modulate their brain activity in response to instructions to perform, voluntarily, mental imagery or when attending to stimuli, presented either auditorily or visually. With these findings the investigators have gathered evidence that electroencephalogram (EEG)-based bedside detection of awareness is possible using Brain- Computer Interface (BCI) technology. BCI technology can provide an alternative communication channel to the physically impaired (PI) which does not depend on neuromuscular control or overt motor control.Study 1 of the project aims to validate the use of EEG-based BCI technology in assessing patients who are in low awareness/unresponsive states and assessing the possibility of using the technology to support diagnosis in clinical practice.
Study 2 of the project aims to apply EEG-based BCI technology with participants who have shown significant brain activation in study 1 with the aim of determining if some patients might be capable of using a BCI as an alternative communication device. Normally BCI technology requires training and feedback over 10+ sessions, each session lasting up to 1.5 hours. Study 2 will involve conducting at least 10 sessions with selected participants.
Study Status:
Recruiting
Disease:
Disorder of Consciousness , Paralysis , Motor Neuron Disease , Stroke , Physical Disability
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Motor imagery based EEG-BCI
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Damien Coyle, PhD, University of Ulster
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Damien Coyle, PhD / email hidden; JavaScript is required / +44 28 7167 5170
Full Study Summary:
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?
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?
Study Sponsor:
University of Ulster
Estimated Enrollment:
30
Estimated Study Start Date:
02 / 08 / 2022
Estimated Study Completion Date:
08 / 01 / 2026
Posting Last Modified Date:
09 / 21 / 2022
Date Study Added to neals.org:
02 / 01 / 2019
Minimum Age:
10 Years
Maximum Age:
80 Years
Study 1 - Initial assessment/screeningInclusion 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
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
Inclusion Criteria:
- 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 who have shown no active brain responses in study 1 where the difference between baseline
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Inspire Neurocare Worcester | Recruiting
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Castel Froma Neuro Care | Recruiting
Elizabeth Jackson / email hidden; JavaScript is required
Damon Hoad / email hidden; JavaScript is required
Principal Investigator : Damon Hoad
Warwick, Warwickshire
CV32 6LL
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The Walton Centre NHS Foundation Trust | Recruiting
Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM / 07816 078 294 Ext. +44 / email hidden; JavaScript is required
Principal Investigator : Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM
Liverpool L9 7LJ
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Abayomi Salawu, MBBS, FWACS, FRCSI, PGCME, MSc / email hidden; JavaScript is required
Hull HU3 2JZ
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NHS Lothian | Recruiting
Dr Alasdair Fitzgerald / email hidden; JavaScript is required
Edinburgh EH9 2HL
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South Eastern Health and Social Care Trust | Not yet recruiting
Dr Josephine Hillan / email hidden; JavaScript is required
Dundonald BT16 1RH
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Frenchay Brain Injury Rehabilitation Centre | Recruiting
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Bristol BS16 2UU
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Sheena Caldwell, MB BCh FRCP(UK) / email hidden; JavaScript is required
Belfast BT9 7AB
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Simon Judge, MEng / email hidden; JavaScript is required
Barnsley S75 2EP
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Northern Health and Social Care Trust | Recruiting
Jacqueline Pogue / email hidden; JavaScript is required
Antrim BT41 2RL
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Woodland Neurological Rehabilitation Centre, York (Christchurch Group) | Recruiting
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York YO10 3HU
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