Detecting awareness in patients with disorders of consciousness
EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability
This study tests if a special brain-monitoring technology can help doctors see if patients with severe consciousness disorders are aware and then teach those who are aware how to communicate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Sponsor | University of Ulster Academic / other |
| Locations | 18 sites (Dublin and 17 other locations) |
| Trial ID | NCT03827187 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of EEG-based brain-computer interface (BCI) technology to assess and enhance awareness in patients diagnosed with disorders of consciousness, such as unresponsive wakefulness syndrome and minimally conscious state. It consists of two phases: the first phase evaluates the percentage of patients showing signs of awareness through EEG, while the second phase focuses on training those identified as aware to communicate using BCI technology. The study aims to determine if EEG data can complement clinical assessments and if BCI can serve as a communication tool for these patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with disorders of consciousness, such as unresponsive wakefulness syndrome or minimally conscious state, as well as those with locked-in syndrome.
Not a fit: Patients with progressive neurological conditions or uncontrolled epilepsy, as well as those experiencing significant pain or cognitive impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a means for patients with disorders of consciousness to communicate and interact with their environment, significantly improving their quality of life.
How similar studies have performed: While the use of EEG-based BCI technology in this context is relatively novel, there have been other studies exploring similar approaches with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dublin and 17 other locations
- National Rehabilitation Hospital of Ireland — Dublin, Ireland (Not_yet_recruiting)
- Castel Froma Neuro Care — Warwick, Warwickshire, United Kingdom (Recruiting)
- Northern Health and Social Care Trust — Antrim, United Kingdom (Recruiting)
- Barnsley Hospital NHS Foundation Trust — Barnsley, United Kingdom (Recruiting)
- Belfast Health and Social Care Trust — Belfast, United Kingdom (Recruiting)
- Frenchay Brain Injury Rehabilitation Centre — Bristol, United Kingdom (Recruiting)
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
- Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom (Recruiting)
- The Walton Centre NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
- The Huntercombe Group — London, United Kingdom (Recruiting)
- Royal Hospital for Neuro-Disability — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- Western Health and Social Care Trust — Londonderry, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Southern Health and Social Care Trust — Portadown, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
- South Warwickshire NHS Foundation Trust — Warwick, United Kingdom (Recruiting)
- Inspire Neurocare Worcester — Worcester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Damien Coyle, PhD — University of Ulster
- Study coordinator: Damien Coyle, PhD
- Email: dh.coyle@ulster.ac.uk
- Phone: +44 28 7167 5170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.