Traumatic Brain Injury With Prolonged Loss of ConsciousnessAWAKENCT03998930
Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients
A study testing Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R) in people with Traumatic Brain Injury With Prolonged Loss of Consciousness and Stroke, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury With Prolonged Loss of Consciousness, Stroke, Brain Hypoxia
- What is being tested?
- Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Mar 2018to 21 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Montpellier
Montpellier, 34000
Clinique Fontfroide
Montpellier, 34097
CHU de Nîmes
Nîmes, 30129
Hôpital d'Uzès
Uzès, 30701
About this study
Official title: 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
Read the 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.
- Being tested
- Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)
- Keywords
- Disorders of consciousness,, Brain Computer Interface, P300, Motor imagery
- Medical subject headings
- Stroke, Hypoxia, Brain, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)Other
Also called other
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start6 Mar 2018
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Prolonged Loss of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- M2H laboratory, Montpellier University, IMT Mines Alès, Alès, France, University Hospital, Montpellier, Hôpital d'Uzès, Uzès, France, Clinique Fontfroide, Montpellier, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998930
- Sponsor's protocol ID
- Local/2017/FF-02
- Other IDs
- 2017-A02539-44
- Acronym
- AWAKE
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-computer Interface in the Diagnosis of Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03998930
- Acronym / sponsor ID
- AWAKE / Local/2017/FF-02
- Keywords
- Disorders of consciousness,, Brain Computer Interface, P300, Motor imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- M2H laboratory, Montpellier University, IMT Mines Alès, Alès, France, University Hospital, Montpellier, Hôpital d'Uzès, Uzès, France, Clinique Fontfroide, Montpellier, France
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brain injuried patients | Experimental | Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)* 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)Also: otherParaclinical 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 | brain injuried patients |
Primary outcome
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
Time frame: Inclusion
correlation coefficient (units: -1; 1)
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
Time frame: Day 2
correlation coefficient (units: -1; 1)
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
Time frame: Day 4
correlation coefficient (units: -1; 1)
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
Time frame: Day 6
correlation coefficient (units: -1; 1)
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
Time frame: Day 10
correlation coefficient (units: -1; 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R) in people with Traumatic Brain Injury With Prolonged Loss of Consciousness and Stroke, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.