Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients
AWAKE
Brain-computer Interface in the Diagnosis of Disorders of Consciousness
2 other identifiers
interventional
9
1 country
4
Brief Summary
The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury. Assumptions :
- Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)
- Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedFirst Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedJuly 19, 2019
July 1, 2019
6 months
June 25, 2019
July 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
correlation between the response of patients obtained with the brain-machine interface (detection of auditory and vibrotactile P300 and modifications of EEG signal during a motor imagery task) and their clinical consciousness score
correlation coefficient (units: -1; 1)
Inclusion
correlation between the response of patients obtained with the brain-machine interface (detection of auditory and vibrotactile P300 and modifications of EEG signal during a motor imagery task) and their clinical consciousness score
correlation coefficient (units: -1; 1)
Day 2
correlation between the response of patients obtained with the brain-machine interface (detection of auditory and vibrotactile P300 and modifications of EEG signal during a motor imagery task) and their clinical consciousness score
correlation coefficient (units: -1; 1)
Day 4
correlation between the response of patients obtained with the brain-machine interface (detection of auditory and vibrotactile P300 and modifications of EEG signal during a motor imagery task) and their clinical consciousness score
correlation coefficient (units: -1; 1)
Day 6
correlation between the response of patients obtained with the brain-machine interface (detection of auditory and vibrotactile P300 and modifications of EEG signal during a motor imagery task) and their clinical consciousness score
correlation coefficient (units: -1; 1)
Day 10
Study Arms (1)
brain injuried patients
EXPERIMENTAL* Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R), * 15-minute break between the two evaluations. * Paraclinical evaluation of consciousness by the brain-machine interface by measuring evoked potentials P300 auditory and vibrotactile and recording the EEG signal during a motor imaging task (imagine moving the right or left wrist).
Interventions
Paraclinical evaluation of consciousness by the brain-machine interface by measuring evoked potentials P300 auditory and vibrotactile and recording the EEG signal during a motor imaging task
Eligibility Criteria
You may qualify if:
- The patient and/or his/her trusted person, relative or legal representative must have given free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- The patient is available for a 10-day follow-up
- Women and men are included
- The patient is at least 18 years old
- Subjects with conscious disorder, non-respondents after traumatic brain injury (head injury) or non-traumatic brain injury (hemorrhagic and/or ischemic stroke, cerebral anoxia, encephalitis).
You may not qualify if:
- Subject is participating in another intervention study
- The subject or his or her trusted person, relative or legal representative refuses to sign the consent
- The patient is pregnant or breastfeeding
- The subject has hemodynamic, respiratory and/or neurological instability
- The subject has an ENT infection in the ears (wearing headphones)
- History of auditory and/or sensory sensory impairment
- Psychiatric history (other than anxiety-depressive syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Nīmeslead
- M2H laboratory, Montpellier Universitycollaborator
- IMT Mines Alès, Alès, Francecollaborator
- University Hospital, Montpelliercollaborator
- Hôpital d'Uzès, Uzès, Francecollaborator
- Clinique Fontfroide, Montpellier, Francecollaborator
Study Sites (4)
CHU de Montpellier
Montpellier, 34000, France
Clinique Fontfroide
Montpellier, 34097, France
CHU de Nîmes
Nîmes, 30129, France
Hôpital d'Uzès
Uzès, 30701, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2019
First Posted
June 26, 2019
Study Start
March 6, 2018
Primary Completion
August 21, 2018
Study Completion
August 21, 2018
Last Updated
July 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share