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โ† Trials
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Awareness Detection and Communication in Disorders of Consciousness

RecruitingNAAges 10 Years - 80 YearsAllUniversity of Ulster
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In plain words

What the trial is, and whether it could suit you

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 disord

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Motor imagery based EEG-BCI
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Where

18 sites
National Rehabilitation Hospital of Ireland
Dublin, Ireland
Castel Froma Neuro Care
Warwick, United Kingdom
Northern Health and Social Care Trust
Antrim, United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Belfast Health and Social Care Trust
Belfast, United Kingdom
Frenchay Brain Injury Rehabilitation Centre
Bristol, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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