Awareness Detection and Communication in Disorders of Consciousness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03827187|
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Consciousness Paralysis Motor Neuron Disease Stroke Physical Disability||Other: Motor imagery based EEG-BCI||Not Applicable|
PRINCIPLE RESEARCH QUESTIONS The project will address a number key principal research questions largely based on two phases to the study.
- What percentage of disorder of consciousness patients assessed provide evidence of awareness using EEG-based BCI technology?
- How does this differ from their clinical diagnosis/prognosis?
- Does the EEG-based information complement or augment the clinical assessment and diagnosis process?
- 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?
- 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?
- 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?
- 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
- Does the technology aid feedback/interpretation on assessment outcomes from consultants?
- How might the experiment provide an opportunity for training others in the deployment of the technology in a clinical setting?
- What types of BCI methods of feedback are best auditory/visual or both, musical or broadband noise, games or applications etc?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability|
|Estimated Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||April 15, 2024|
|Estimated Study Completion Date :||April 15, 2024|
Experimental: 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.
Other: 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.
- Change in performance accuracy of BCI use pre- and post- training [ Time Frame: 10 sessions of ~1.5 hours ]
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).
- 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 [ Time Frame: 3-4 sessions of ~1.5 hours ]
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.
Your name is David. You are 25 years old.
- Diagnostic utility of BCI data provided through study completion to clinicians [ Time Frame: 2 - 7 weeks. Duration of study which lasts 10 sessions of ~1.5 hours in addition to some time for analysis/reporting of results ]
The performance accuracy of the participant in producing consistent cue- induced imagined movements appropriately in timed paradigms will be assessed across sessions, to determine variability and consistency in performance accuracy. The affects of real-time feedback will be looked at, alongside differences in performance accuracy across question subcategories. Performance accuracy per question subcategory will be assessed to evaluate awareness of self versus awareness of environment and understanding of numbers and letters, and logic.
Whether this information is in line with the patient's current diagnosis/CRS-R and WHIM scores will be assessed in order to further understand whether the technology can aid feedback/interpretation on assessment outcomes from consultants?
- Changes in Wessex Head Injury Matrix and Coma Recovery Scale Scores due to potential therapeutic benefit of engaging in motor imagery [ Time Frame: 10 sessions of ~1.5 hours ]Is there a benefit to intentionally modulating motor cortex regions in response to a command in a timed paradigm over multiple sessions. In participants with a Prolonged Disorder of Consciousness the scores for The Wessex Head Injury Matrix and Coma-Recovery Scale Revised taken at each session will be looked at to seek out therapeutic benefit. Here therapeutic benefit is defined in terms of changes in state of arousal and awareness of self/environment. Therapeutic benefit may also be assessed via performance given as an accuracy percentage of motor imagery trials successfully completed, and how this changes over time.
- Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise, [ Time Frame: 10 sessions of ~1.5hours ]Is there a significant difference in performance as a function of type of feedback participant was receiving - music clips or broadband noise.
- Changes in performance accuracy as a results of time of day of research experimentation [ Time Frame: 10 sessions of ~1.5hours ]Arousability varies with time of day - is this reflected in BCI use performance or do some patients perform more optimally at a particular time? The aim is to perform 5 sessions in the morning and 5 in the afternoon to look at the affects of time of day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827187
|Contact: Damien Coyle, PhD||+44 28 7167 firstname.lastname@example.org|
|Contact: Natalie Dayan, MResemail@example.com|