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Awareness Detection and Communication in Disorders of Consciousness

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ClinicalTrials.gov Identifier: NCT03827187
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
National Rehabilitation Hospital, Ireland
St Conal’s Campus Rehabilitation Unit, Letterkenny, Ireland
Belfast Health and Social Care Trust
Western Health and Social Care Trust
South Eastern Health and Social Care Trust
Southern Health and Social Care Trust
Northern Health and Social Care Trust
Barnsley Hospital NHS Foundation Trust
NHS Lothian
Walton Centre NHS Foundation Trust
Hull University Teaching Hospitals NHS Trust
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Woodland Neuro rehab Center, York (Christchurch Group)
Glenside care, Salisbury
Frenchay Brain Injury Rehabilitation Centre, Bristol
Royal Hospital for Neuro-disability
Information provided by (Responsible Party):
University of Ulster

Brief Summary:

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

Detailed Description:

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


  2. 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.

    Yes Questions:

    Your name is David. You are 25 years old.



Secondary Outcome Measures :
  1. 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?


  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study 1 - Initial assessment/screening

Inclusion 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


Information from the National Library of Medicine

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


Contacts
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Contact: Damien Coyle, PhD +44 28 7167 5170 dh.coyle@ulster.ac.uk
Contact: Natalie Dayan, MRes 07739544751 n.dayan@ulster.ac.uk

Sponsors and Collaborators
University of Ulster
National Rehabilitation Hospital, Ireland
St Conal’s Campus Rehabilitation Unit, Letterkenny, Ireland
Belfast Health and Social Care Trust
Western Health and Social Care Trust
South Eastern Health and Social Care Trust
Southern Health and Social Care Trust
Northern Health and Social Care Trust
Barnsley Hospital NHS Foundation Trust
NHS Lothian
Walton Centre NHS Foundation Trust
Hull University Teaching Hospitals NHS Trust
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Woodland Neuro rehab Center, York (Christchurch Group)
Glenside care, Salisbury
Frenchay Brain Injury Rehabilitation Centre, Bristol
Royal Hospital for Neuro-disability
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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT03827187    
Other Study ID Numbers: 136640
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paralysis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Consciousness Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Neurobehavioral Manifestations
Neurocognitive Disorders
Mental Disorders