Advancing EEG-based assessment of consciousness and cognition in prolonged disorders of consciousness.
Naomi du Bois, Attila Korik, Stephanie Hodge...
https://pubmed.ncbi.nlm.nih.gov/41998183Actively Recruiting
Led by University of Ulster · Updated on 2024-12-13
30
Participants Needed
18
Research Sites
N/A
Total Duration
U
University of Ulster
Lead Sponsor
N
National Rehabilitation Hospital, Dublin, Ireland (NRH)
Collaborating Sponsor
Researchers are evaluating the use of EEG-based Brain-Computer Interface (BCI) technology to detect awareness and enable communication in people with prolonged disorders of consciousness (DoC), such as unresponsive wakefulness syndrome (UWS), minimally conscious state (MCS), and locked-in syndrome (LIS). The study aims to improve diagnosis accuracy where traditional methods relying on motor responses may fail, and to explore if BCI can provide movement-independent communication. The trial also investigates whether training with BCI can enhance brain response consistency and communication ability. Participants undergo three phases: Phase I assesses if patients can imagine movements and produce detectable brain activity using EEG. Phase II involves training with motor imagery BCI and real-time auditory feedback to help participants modulate brain signals. Phase III tests participants' ability to answer yes-no questions using imagined movement patterns. The study uses specific imagined movement combinations to represent 'yes' or 'no' responses, tailored individually and applied throughout sessions lasting about 1.5 hours each. During the study, participants complete up to 10 sessions including assessments, training, and communication tasks. Researchers monitor changes in BCI performance accuracy, ability to communicate consistently, and clinical scale scores related to consciousness and recovery. The study evaluates how feedback types and timing affect performance and collects data to support clinical diagnosis and potential therapeutic benefits. Participation involves EEG recordings, neurofeedback, and answering structured questions over several weeks.
CONDITIONS
Awareness Detection and Communication in Disorders of Consciousness
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo a brief assessment of motor imagery ability in response to commands using EEG-based brain-computer interfacing to detect signs of awareness.
1 to 2 visits depending on participant response
Duration - Approximately 3 to 4 weeks with around 10 sessions
Participants who show signs of awareness participate in multiple sessions of auditory feedback training using imagined movements to improve performance and communicate yes-no responses to questions.
Approximately 10 sessions of about 1.5 hours each
Duration - Up to 1 week following training
Participants' performance and communication ability is monitored, and data is analyzed to evaluate diagnostic utility and potential therapeutic benefits.
1 to 2 follow-up visits
Total: 18 locations
1
National Rehabilitation Hospital of Ireland
Dublin, Ireland, A96 E2H2
Not Yet Recruiting
2
Castel Froma Neuro Care
Warwick, Warwickshire, United Kingdom, CV32 6LL
Actively Recruiting
3
Northern Health and Social Care Trust
Antrim, United Kingdom, BT41 2RL
Actively Recruiting
4
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom, S75 2EP
Actively Recruiting
5
Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
6
Frenchay Brain Injury Rehabilitation Centre
Bristol, United Kingdom, BS16 2UU
Actively Recruiting
7
NHS Lothian
Edinburgh, United Kingdom, EH9 2HL
Actively Recruiting
8
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
9
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom, L9 7LJ
Actively Recruiting
10
The Huntercombe Group
London, United Kingdom, SE10 8AD
Actively Recruiting
11
Royal Hospital for Neuro-Disability
London, United Kingdom, SW15 3SW
Actively Recruiting
12
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Actively Recruiting
13
Western Health and Social Care Trust
Londonderry, United Kingdom, BT47 6SB
Actively Recruiting
14
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7HE
Actively Recruiting
15
Southern Health and Social Care Trust
Portadown, United Kingdom, BT63 5QQ
Actively Recruiting
16
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
17
South Warwickshire NHS Foundation Trust
Warwick, United Kingdom, CV34 5BW
Actively Recruiting
18
Inspire Neurocare Worcester
Worcester, United Kingdom, WR2 6AS
Actively Recruiting
D
Damien Coyle, PhD
N
Naomi du Bois, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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Naomi du Bois, Attila Korik, Stephanie Hodge...
https://pubmed.ncbi.nlm.nih.gov/41998183