Actively Recruiting

Phase Not Applicable
Age: 10Years - 80Years
All Genders
ID03827187

EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability

Led by University of Ulster · Updated on 2024-12-13

30

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Ulster

Lead Sponsor

N

National Rehabilitation Hospital, Dublin, Ireland (NRH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Awareness Detection and Communication in Disorders of Consciousness

Who Can Participate

Age: 10Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 10 and 80 years
  • Diagnosis of disorder of consciousness or low awareness state including vegetative state, minimally conscious state, or locked-in syndrome
  • Acute or post-acute patients when appropriate
  • Identified signs of awareness based on brain activation for BCI training phase
Not Eligible

You will not qualify if you...

  • Brain diseases or illnesses like progressive neurological conditions or uncontrolled epilepsy
  • Current use of medications causing excessive fatigue or affecting cognitive function
  • Non-English speakers
  • Excessive uncontrollable arm or head movements or teeth grinding that degrade EEG quality
  • No active brain responses during initial assessment for BCI training phase

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Training and Communication

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

Observation and Analysis

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

Trial Site Locations

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

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Research Team

D

Damien Coyle, PhD

N

Naomi du Bois, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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