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.
Disorder of Consciousness , Paralysis , Motor Neuron Disease , Stroke , Physical Disability
Type of Intervention:
Motor imagery based EEG-BCI
Study Chair(s)/Principal Investigator(s):
Damien Coyle, PhD, University of Ulster
Coordinating Center Contact Information
Full Study Summary:
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?
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?
University of Ulster
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
80 YearsStudy 1 - Initial assessment/screening
- 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
- 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
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