[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100349236":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":276,"collaborators":278,"id":305,"slug":306,"hasResults":307,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":19,"eligibilityCriteria":311,"healthyVolunteers":307,"sex":312,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":19,"studyType":318,"phases":319,"briefSummary":321,"conditions":322,"keywords":19,"overallStatus":53,"whyStopped":19,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},{"fullName":5,"class":6},"University of Ulster","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Motor imagery based Brain computer interfacing","EXPERIMENTAL","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.",[13],"Other: Motor imagery based EEG-BCI",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"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\u002Fletters questions.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Damien Coyle, PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+44 28 7167 5170","dh.coyle@ulster.ac.uk",{"name":30,"role":26,"phone":31,"phoneExt":19,"email":32},"Naomi du Bois, PhD","+44 28 7167 5321","n.du-bois@ulster.ac.uk",[34,51,72,85,98,111,124,137,150,166,179,189,199,212,225,238,251,261],{"facility":35,"status":36,"city":37,"state":19,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"National Rehabilitation Hospital of Ireland","NOT_YET_RECRUITING","Dublin","A96 E2H2","Ireland","IE",{"type":42,"coordinates":43},"Point",[44,45],-6.24889,53.33306,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":19,"phoneExt":19,"email":50},"Dr Valerie Twomey","Valerie.Twomey@nrh.ie",{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Castel Froma Neuro Care","RECRUITING","Warwick","Warwickshire","CV32 6LL","United Kingdom","UK",{"type":42,"coordinates":60},[61,62],-1.58333,52.28333,{"lat":62,"lon":61},[65,68,71],{"name":66,"role":26,"phone":19,"phoneExt":19,"email":67},"Elizabeth Jackson","elizabeth.jackson@castelfroma.org.uk",{"name":69,"role":26,"phone":19,"phoneExt":19,"email":70},"Damon Hoad","Damon.Hoad@warwick.ac.uk",{"name":69,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":73,"status":53,"city":74,"state":19,"zip":75,"country":57,"countryCode":58,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Northern Health and Social Care Trust","Antrim","BT41 2RL",{"type":42,"coordinates":77},[78,79],-6.211,54.7175,{"lat":79,"lon":78},[82],{"name":83,"role":26,"phone":19,"phoneExt":19,"email":84},"Jacqueline Pogue","jacqueline.pogue@northerntrust.hscni.net",{"facility":86,"status":53,"city":87,"state":19,"zip":88,"country":57,"countryCode":58,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Barnsley Hospital NHS Foundation Trust","Barnsley","S75 2EP",{"type":42,"coordinates":90},[91,92],-1.48333,53.55,{"lat":92,"lon":91},[95],{"name":96,"role":26,"phone":19,"phoneExt":19,"email":97},"Simon Judge, MEng","simon.judge@nhs.net",{"facility":99,"status":53,"city":100,"state":19,"zip":101,"country":57,"countryCode":58,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Belfast Health and Social Care Trust","Belfast","BT9 7AB",{"type":42,"coordinates":103},[104,105],-5.92541,54.59682,{"lat":105,"lon":104},[108],{"name":109,"role":26,"phone":19,"phoneExt":19,"email":110},"Sheena Caldwell, MB BCh FRCP(UK)","sheena.caldwell@belfasttrust.hscni.net",{"facility":112,"status":53,"city":113,"state":19,"zip":114,"country":57,"countryCode":58,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Frenchay Brain Injury Rehabilitation Centre","Bristol","BS16 2UU",{"type":42,"coordinates":116},[117,118],-2.59665,51.45523,{"lat":118,"lon":117},[121],{"name":122,"role":26,"phone":19,"phoneExt":19,"email":123},"Suzanne Moss","Suzanne.Moss@huntercombe.com",{"facility":125,"status":53,"city":126,"state":19,"zip":127,"country":57,"countryCode":58,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"NHS Lothian","Edinburgh","EH9 2HL",{"type":42,"coordinates":129},[130,131],-3.19648,55.95206,{"lat":131,"lon":130},[134],{"name":135,"role":26,"phone":19,"phoneExt":19,"email":136},"Dr Alasdair Fitzgerald","alasdair.fitzgerald@nhslothian.scot.nhs.uk",{"facility":138,"status":53,"city":139,"state":19,"zip":140,"country":57,"countryCode":58,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hull University Teaching Hospitals NHS Trust","Hull","HU3 2JZ",{"type":42,"coordinates":142},[143,144],-0.33525,53.7446,{"lat":144,"lon":143},[147],{"name":148,"role":26,"phone":19,"phoneExt":19,"email":149},"Abayomi Salawu, MBBS, FWACS, FRCSI, PGCME, MSc","abayomi.salawu@nhs.net",{"facility":151,"status":53,"city":152,"state":19,"zip":153,"country":57,"countryCode":58,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"The Walton Centre NHS Foundation Trust","Liverpool","L9 7LJ",{"type":42,"coordinates":155},[156,157],-2.97794,53.41058,{"lat":157,"lon":156},[160,165],{"name":161,"role":26,"phone":162,"phoneExt":163,"email":164},"Ganesh Bavikatte, MBBS, MD, FRCP(London), FEBPRM","07816 078 294","+44","ganesh.bavikatte@thewaltoncentre.nhs.uk",{"name":161,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":167,"status":53,"city":168,"state":19,"zip":169,"country":57,"countryCode":58,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"The Huntercombe Group","London","SE10 8AD",{"type":42,"coordinates":171},[172,173],-0.12574,51.50853,{"lat":173,"lon":172},[176],{"name":177,"role":26,"phone":19,"phoneExt":19,"email":178},"Samantha Mcantagart","samantha.mcantagart@huntercombe.com",{"facility":180,"status":53,"city":168,"state":19,"zip":181,"country":57,"countryCode":58,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Royal Hospital for Neuro-Disability","SW15 3SW",{"type":42,"coordinates":183},[172,173],{"lat":173,"lon":172},[186],{"name":187,"role":26,"phone":19,"phoneExt":19,"email":188},"Lloyd Bradley, MD","lbradley@rhn.org.uk",{"facility":190,"status":53,"city":168,"state":19,"zip":191,"country":57,"countryCode":58,"cosmosGeoPoint":192,"geoPoint":194,"contacts":195},"Imperial College Healthcare NHS Trust","W6 8RF",{"type":42,"coordinates":193},[172,173],{"lat":173,"lon":172},[196],{"name":197,"role":26,"phone":19,"phoneExt":19,"email":198},"Dr Paul Bentley","p.bentley@imperial.ac.uk",{"facility":200,"status":53,"city":201,"state":19,"zip":202,"country":57,"countryCode":58,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Western Health and Social Care Trust","Londonderry","BT47 6SB",{"type":42,"coordinates":204},[205,206],-7.30934,54.9981,{"lat":206,"lon":205},[209],{"name":210,"role":26,"phone":19,"phoneExt":19,"email":211},"Dr Paul Johnson","paul.johnson@westerntrust.hscni.net",{"facility":213,"status":53,"city":214,"state":19,"zip":215,"country":57,"countryCode":58,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Oxford University Hospitals NHS Foundation Trust","Oxford","OX3 7HE",{"type":42,"coordinates":217},[218,219],-1.25596,51.75222,{"lat":219,"lon":218},[222],{"name":223,"role":26,"phone":19,"phoneExt":19,"email":224},"Emma Dodds","Emma.Dodds@ouh.nhs.uk",{"facility":226,"status":53,"city":227,"state":19,"zip":228,"country":57,"countryCode":58,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Southern Health and Social Care Trust","Portadown","BT63 5QQ",{"type":42,"coordinates":230},[231,232],-6.44434,54.42302,{"lat":232,"lon":231},[235],{"name":236,"role":26,"phone":19,"phoneExt":19,"email":237},"Dr Bernadette Salisbury","Bernadette.Salisbury@southerntrust.hscni.ne",{"facility":239,"status":53,"city":240,"state":19,"zip":241,"country":57,"countryCode":58,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield","S10 2JF",{"type":42,"coordinates":243},[244,245],-1.4659,53.38297,{"lat":245,"lon":244},[248],{"name":249,"role":26,"phone":19,"phoneExt":19,"email":250},"Sivaraman Nair, DM, FRCP","siva.nair@nhs.net",{"facility":252,"status":53,"city":54,"state":19,"zip":253,"country":57,"countryCode":58,"cosmosGeoPoint":254,"geoPoint":256,"contacts":257},"South Warwickshire NHS Foundation Trust","CV34 5BW",{"type":42,"coordinates":255},[61,62],{"lat":62,"lon":61},[258],{"name":259,"role":26,"phone":19,"phoneExt":19,"email":260},"Dr Damon Hoad","Damon.Hoad@swft.nhs.uk",{"facility":262,"status":53,"city":263,"state":19,"zip":264,"country":57,"countryCode":58,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Inspire Neurocare Worcester","Worcester","WR2 6AS",{"type":42,"coordinates":266},[267,268],-2.22001,52.18935,{"lat":268,"lon":267},[271,274,275],{"name":272,"role":26,"phone":19,"phoneExt":19,"email":273},"Harriet Miller","Worcester.CL@inspireneurocare.co.uk",{"name":69,"role":26,"phone":19,"phoneExt":19,"email":70},{"name":69,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":277,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[279,282,283,284,286,287,288,289,291,292,293,295,296,297,299,300,302,303],{"name":280,"class":281},"National Rehabilitation Hospital, Dublin, Ireland (NRH)","UNKNOWN",{"name":99,"class":6},{"name":200,"class":6},{"name":226,"class":285},"OTHER_GOV",{"name":73,"class":285},{"name":86,"class":6},{"name":125,"class":285},{"name":290,"class":6},"Walton Centre NHS Foundation Trust",{"name":138,"class":285},{"name":190,"class":6},{"name":294,"class":6},"Royal Hospital for Neuro-disability",{"name":252,"class":6},{"name":239,"class":6},{"name":298,"class":6},"Oxford University Hospitals NHS Trust",{"name":52,"class":281},{"name":301,"class":281},"Inspire Neurocare",{"name":167,"class":281},{"name":304,"class":281},"Active Care Group","100349236","awareness-detection-and-communication-in-disorders-of-consciousness-100349236",false,"NCT03827187","Awareness Detection and Communication in Disorders of Consciousness","EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability","Study 1 - Initial assessment\u002Fscreening\n\nInclusion Criteria:\n\n* 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 \u002F 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.\n* acute, post-acute patients where appropriate\n\nExclusion Criteria:\n\n* 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.\n* Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning\n* Where English is not the individual's first language\n* Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.\n\nStudy 2 - BCI training\n\nInclusion Criteria:\n\n\\- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and\u002For those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.\n\nExclusion Criteria:\n\n\\- Participants who have shown no active brain responses in study 1 where the difference between baseline","ALL","10 Years","80 Years",{"count":316,"type":317},30,"ESTIMATED","INTERVENTIONAL",[320],"NA","STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are \"awake\" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.",[323,324,325,326,327],"Disorder of Consciousness","Paralysis","Motor Neuron Disease","Stroke","Physical Disability","2024-12-09",{"date":330,"type":331},"2024-12-13","ACTUAL",{"date":333,"type":331},"2022-02-08",{"date":335,"type":317},"2026-08",{"name":5,"class":6},18]