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

Study ID: 53001
Short Title: Awareness Detection and Communication inDisorders of Consciousness
Organisation: University Hospital Southampton NHS Foundation Trust
Location: Southampton General Hospital
Condition: Other
Main Specialty: Neurological disorders
Expected End Date: 31/08/2026
Postcode: SO16 6YD
Contact Name: R&D department
Contact Email: R&
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Study 1 – initial assessment/screeningThose with a disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in lowawareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome / completedlocked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems thatwould preclude them from participating may be assessed but considered as a separate cohort to those with lowawareness states. The majority of participants will be referred by consultants involved in diagnosis and prescribingcare requirements. In a minority of cases family members may request participation and in such cases inclusion inthe study will be discussed with carers and medical teams where possible. acute, post-acute patients where appropriateAge 10​-80 yearsThe lower bound on the age limit is to ensure participant are mature enough to follow instructions. The upper bound isminimise the risk of normal cognitive decline having an impact on results. Study 2 – BCI training Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and or thosewho have known awareness but are target groups for movement independent assistive devices and technologiescontrolled using a brain-computer interface.

Study 1 - Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolledepilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable forthe 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 Age < 10 years or > 80 yearsParticipant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will bedegraded significantly.Study 2Participants who have shown no active brain responses in study 1 where the difference between baseline activity andevent related activity is statistically insignificant after two initial assessment sessions. Participants who are unable to commit to partaking in a minimum of 10 sessions with each session lasting aminimum duration of one hour but no longer than 1.5 hours (training is required over multiple sessions).

Severely altered consciousness most often occurs as a result of brain injury. Some injuries are mild and may causerelatively minor changes in consciousness however a condition may arise where a person is considered to be in avegetative state, where they are "awake" but unaware. Up to 43% of patients with vegetative state diagnosis arereclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimallyconscious state (MCS) and all in vegetative state (VS) are incapable of providing any overt motor responses andtherefore, in some cases, existing consciousness scales are not wholly sufficient for assessment. There is evidencethat a subset of patients with these prolonged disorders of consciousness (DoC) can, modulate their brain activity inresponse to instructions to perform, voluntarily, mental imagery or when attending to stimuli, presented either auditorilyor visually. With these findings we have gathered evidence that electroencephalogram (EEG)-based bedside detectionof awareness is possible using Brain-Computer Interface (BCI) technology. BCI technology can provide an alternativecommunication channel to the physically impaired (PI) which does not depend on neuromuscular control or overtmotor control.Study 1 of the project aims to validate the use of EEG-based BCI technology in assessing patients who are in lowawareness/unresponsive states and assessing the possibility of using the technology to support diagnosis in clinicalpractice. Study 2 of the project aims to apply EEG-based BCI technology with participants who have shown significant brainactivation in study 1 with the aim of determining if some patients might be capable of using a BCI as an alternativecommunication device. Normally BCI technology requires training and feedback over 10+ sessions, each sessionlasting up to 1.5 hours. Study 2 will involve conducting at least 10 sessions with selected participants.

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