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Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients (AWAKE)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Traumatic Brain Injury With Prolonged Loss of Consciousness Stroke Brain Hypoxia | Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R) | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Brain-computer Interface in the Diagnosis of Disorders of Consciousness |
| Actual Study Start Date : | March 6, 2018 |
| Actual Primary Completion Date : | August 21, 2018 |
| Actual Study Completion Date : | August 21, 2018 |
| Arm | Intervention/treatment |
|---|---|
Experimental: brain injuried patients
|
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 Name: other
|
- 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)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
| France | |
| CHU de Montpellier | |
| Montpellier, France, 34000 | |
| Clinique Fontfroide | |
| Montpellier, France, 34097 | |
| CHU de Nîmes | |
| Nîmes, France, 30129 | |
| Hôpital d'Uzès | |
| Uzès, France, 30701 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||
| First Posted Date ICMJE | June 26, 2019 | ||||
| Last Update Posted Date | July 19, 2019 | ||||
| Actual Study Start Date ICMJE | March 6, 2018 | ||||
| Actual Primary Completion Date | August 21, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients | ||||
| Official Title ICMJE | Brain-computer Interface in the Diagnosis of Disorders of Consciousness | ||||
| 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 :
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
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| Intervention ICMJE | 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 Name: other
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| Study Arms ICMJE | Experimental: brain injuried patients
Intervention: Other: Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
9 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | August 21, 2018 | ||||
| Actual Primary Completion Date | August 21, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03998930 | ||||
| Other Study ID Numbers ICMJE | Local/2017/FF-02 2017-A02539-44 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nīmes | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| PRS Account | Centre Hospitalier Universitaire de Nīmes | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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