Detecting awareness in patients with disorders of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.