- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827187
Awareness Detection and Communication in Disorders of Consciousness
EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability
Study Overview
Status
Intervention / Treatment
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
- 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?
Phase/study 2
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Damien Coyle, PhD
- Phone Number: +44 28 7167 5170
- Email: dh.coyle@ulster.ac.uk
Study Contact Backup
- Name: Naomi du Bois, PhD
- Phone Number: +44 28 7167 5321
- Email: n.du-bois@ulster.ac.uk
Study Locations
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Dublin, Ireland, A96 E2H2
- Not yet recruiting
- National Rehabilitation Hospital of Ireland
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Contact:
- Dr Valerie Twomey
- Email: Valerie.Twomey@nrh.ie
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Antrim, United Kingdom, BT41 2RL
- Recruiting
- Northern Health and Social Care Trust
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Contact:
- Jacqueline Pogue
- Email: jacqueline.pogue@northerntrust.hscni.net
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Barnsley, United Kingdom, S75 2EP
- Recruiting
- Barnsley Hospital NHS Foundation Trust
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Contact:
- Simon Judge, MEng
- Email: simon.judge@nhs.net
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Belfast, United Kingdom, BT9 7AB
- Recruiting
- Belfast Health and Social Care Trust
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Contact:
- Sheena Caldwell, MB BCh FRCP(UK)
- Email: sheena.caldwell@belfasttrust.hscni.net
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Bristol, United Kingdom, BS16 2UU
- Recruiting
- Frenchay Brain Injury Rehabilitation Centre
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Contact:
- Suzanne Moss
- Email: Suzanne.Moss@huntercombe.com
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Edinburgh, United Kingdom, EH9 2HL
- Recruiting
- NHS Lothian
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Contact:
- Dr Alasdair Fitzgerald
- Email: alasdair.fitzgerald@nhslothian.scot.nhs.uk
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Hull, United Kingdom, HU3 2JZ
- Recruiting
- Hull University Teaching Hospitals NHS Trust
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Contact:
- Abayomi Salawu, MBBS, FWACS, FRCSI, PGCME, MSc
- Email: abayomi.salawu@nhs.net
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Liverpool, United Kingdom, L9 7LJ
- Recruiting
- The Walton Centre NHS Foundation Trust
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Contact:
- Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM
- Phone Number: +44 07816 078 294
- Email: ganesh.bavikatte@thewaltoncentre.nhs.uk
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Principal Investigator:
- Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM
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London, United Kingdom, W6 8RF
- Recruiting
- Imperial College Healthcare NHS Trust
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Contact:
- Dr Paul Bentley
- Email: p.bentley@imperial.ac.uk
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London, United Kingdom, SE10 8AD
- Recruiting
- The Huntercombe Group
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Contact:
- Samantha Mcantagart
- Email: samantha.mcantagart@huntercombe.com
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London, United Kingdom, SW15 3SW
- Recruiting
- Royal Hospital for Neuro-disability
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Contact:
- Lloyd Bradley, MD
- Email: lbradley@rhn.org.uk
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Londonderry, United Kingdom, BT47 6SB
- Recruiting
- Western Health and Social Care Trust
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Contact:
- Dr Paul Johnson
- Email: paul.johnson@westerntrust.hscni.net
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Oxford, United Kingdom, OX3 7HE
- Recruiting
- Oxford University Hospitals NHS Foundation Trust
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Contact:
- Emma Dodds
- Email: Emma.Dodds@ouh.nhs.uk
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Portadown, United Kingdom, BT63 5QQ
- Recruiting
- Southern Health and Social Care Trust
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Contact:
- Dr Bernadette Salisbury
- Email: Bernadette.Salisbury@southerntrust.hscni.ne
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Sheffield, United Kingdom, S10 2JF
- Recruiting
- Sheffield Teaching Hospitals NHS Foundation Trust
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Contact:
- Sivaraman Nair, DM, FRCP
- Email: siva.nair@nhs.net
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Warwick, United Kingdom, CV34 5BW
- Recruiting
- South Warwickshire NHS Foundation Trust
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Contact:
- Dr Damon Hoad
- Email: Damon.Hoad@swft.nhs.uk
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Worcester, United Kingdom, WR2 6AS
- Recruiting
- Inspire Neurocare Worcester
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Contact:
- Damon Hoad
- Email: Damon.Hoad@warwick.ac.uk
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Principal Investigator:
- Damon Hoad
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Contact:
- Harriet Miller
- Email: Worcester.CL@inspireneurocare.co.uk
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Warwickshire
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Warwick, Warwickshire, United Kingdom, CV32 6LL
- Recruiting
- Castel Froma Neuro Care
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Contact:
- Elizabeth Jackson
- Email: elizabeth.jackson@castelfroma.org.uk
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Contact:
- Damon Hoad
- Email: Damon.Hoad@warwick.ac.uk
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Principal Investigator:
- Damon Hoad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in performance accuracy of BCI use pre- and post- training
Time Frame: ~10 sessions of ~1.5 hours
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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). |
~10 sessions of ~1.5 hours
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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
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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. |
3-4 sessions of ~1.5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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 - 7 weeks. Duration of study which lasts 10 sessions of ~1.5 hours in addition to some time for analysis/reporting of results
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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
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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.
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~10 sessions of ~1.5 hours
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Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise,
Time Frame: ~10 sessions of ~1.5hours
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Is there a significant difference in performance as a function of type of feedback participant was receiving - music clips or broadband noise.
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~10 sessions of ~1.5hours
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Changes in performance accuracy as a results of time of day of research experimentation
Time Frame: ~10 sessions of ~1.5hours
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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.
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~10 sessions of ~1.5hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Damien Coyle, PhD, University of Ulster
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Paralysis
- Consciousness Disorders
Other Study ID Numbers
- 136640
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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