Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients (AWAKE)

Brain-computer Interface in the Diagnosis of Disorders of Consciousness

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

Study Overview

• Status: Completed
• Conditions: Stroke; Brain Hypoxia; Traumatic Brain Injury With Prolonged Loss of Consciousness
• Intervention / Treatment: Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)

Detailed Description

this is a pilot study on information obtained using a medical device marketed in accordance with CE standards, multicentric and prospective.

The study participation consists of five assessments of the subjects' level of awareness. Each evaluation lasts a total of two hours.

Patients will be assessed in their rooms as follows:

• Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R), a clinical scale considered as the "gold-standard". Duration 45 minutes (standard care in routine care)
• 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). Duration 60 minutes.

Instructions are given to the subject via headphones, in French. For the analysis of the evoked potentials, vibrotactile stimuli are delivered to the wrists and ankle of the subject. For auditory evoked potentials, auditory stimuli are delivered by headphones. The volume can be changed.

These assessments that we will perform with the brain-machine interface are similar to the assessments and stimulation of awakening and awareness sessions performed by speech-language pathologists in the departments concerned (presentation of visual and auditory stimuli). CRS-R is used in routine care to assess patients' level of consciousness. There is no recommendation on the type of additional examination to be performed (neuroimaging, EEG, evoked potentials) or on their frequency for the evaluation of patients' consciousness at a distance from their initial brain injury.

Evaluation by the brain-machine interface in the room makes it possible to avoid transport to the complementary examination services (Medical Imaging Services, Neurological Functional Explorations) which cause fatigue (patient whose vigilance is fluctuating) which can make the complementary examination non-contributory. Patients are also not assessed at a date and time set by a complementary examination service and room assessment allows the patient to be assessed in the best conditions for him/her when he/she appears to be at his/her highest level of consciousness and rested (after consultation with the family and/or healthcare team).

Total duration of each session of a maximum of 2 hours, including the installation and uninstallation of the brain-machine interface.

Patients receive their usual treatment and continue to participate in rehabilitation.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • CHU de Montpellier
  • Montpellier, France, 34097
    • Clinique Fontfroide
  • Nîmes, France, 30129
    • CHU de NIMES
  • Uzès, France, 30701
    • Hôpital d'Uzès

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Subject is participating in another intervention study
• The subject is in an exclusion period determined by a previous 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brain injuried patients; 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).	Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R); 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; Other Names: other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: University Hospital, Montpellier; M2H laboratory, Montpellier University; IMT Mines Alès, Alès, France; Hôpital d'Uzès, Uzès, France; Clinique Fontfroide, Montpellier, France

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): August 21, 2018

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Motor imagery; P300; Brain Computer Interface; Disorders of consciousness,
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms, Respiratory; Consciousness Disorders; Brain Injuries; Brain Injuries, Traumatic; Hypoxia; Unconsciousness; Hypoxia, Brain
• Other Study ID Numbers: Local/2017/FF-02; 2017-A02539-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No