Awareness Detection and Communication in Disorders of Consciousness

Launched by UNIVERSITY OF ULSTER · Jan 30, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how to detect awareness in patients with disorders of consciousness, such as those who are in a vegetative state or minimally conscious state. The goal is to find better ways to understand if these patients have any conscious awareness, which is often difficult to assess because they may not be able to respond physically. Researchers are using a technique called electroencephalography (EEG) to measure brain activity while patients try to imagine different movements. By analyzing these patterns, they want to see if patients can communicate "yes" or "no" answers to questions based on their brain activity.

To participate in the trial, individuals should have a diagnosis of a disorder of consciousness or locked-in syndrome and be able to follow instructions. Those who have severe brain conditions or certain medical issues that could interfere with the study will not be eligible. Participants will go through three phases, starting with assessments to see if they can imagine movements, followed by training to help them learn how to use their brain signals to communicate, and finally, they will answer questions to assess their awareness. This research aims to improve how we evaluate and assist patients who are unable to move or speak but may still have some level of consciousness.

Gender

ALL

Eligibility 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