Circadian Rhythmicity During Coma Awakening
Overview
- Phase
- Not Applicable
- Intervention
- Repeated behavioural assessment
- Conditions
- Acute Brain Injury Coma
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Consciousness outcome
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
Acute brain injury is a major cause of admission to intensive care units, as well as of mortality and morbidity, worldwide and for all age groups. With most patients surviving these injuries thanks to recent medical advances, society is facing not only the growing burden of disability, but above all the ethical issues involved in withdrawal of life-sustaining therapies (WSLT). To resolve this dilemma, effective treatment would be necessary, but this is hampered by our limited knowledge of the pathophysiological mechanisms of the natural history of coma, from onset to recovery. A more systematic description of coma awakening using a multimodal battery in intensive care unit patients would enable us to refine the awakening and re-emergence of consciousness and define appropriate biomarkers for selecting candidates in interventional studies.
The investigators hypothesize that the current postulate of successive stages (i.e. from one clinical class to the next) of coma recovery is incomplete, as it does not take into account the rhythmic nature of wakefulness. The investigators propose that the best correlate of the natural history of coma recovery is a gradual shift from the loss of physiological cycles to a circadian rhythmicity of arousal indices (behavioural and neurophysiological) and a wide amplitude of metric fluctuations in assessing content richness.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Admission to the Neurological Intensive Care Unit
- •Initial disorder of consciousness (GCS \< 8) or initial brain lesion (on CT or MRI) requiring intubation and sedation during management (for upper airway protection or due to coma)
- •Intubated patient under mechanical ventilation wwith no response to simple commands
- •Weaning from sedation : acquired / possible within 7 days of inclusion in the absence of new complications
- •Severity of clinical or morphological impairment leading to risk of persistent disturbance of consciousness
- •Sedation discontinued or able to be discontinued within 3 month of initial management of the disorder of consciousness or brain injury
- •Effective treatment of the cause of admission without risk of short-term recurrence
- •Patient aged 17 or over
- •Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1
- •Presence of relatives able to sign consent or of the minor's legal representative
Exclusion Criteria
- •Subjects with a contraindication to MRI scans
- •Admission for status epilepticus
- •Existence of status epilepticus during the stay and persisting for \> 24h or presenting an electrical remission for less than 48h prior to inclusion
- •Post-anoxic coma with bilateral abolition of N20 PES cortical responses
- •Coma related to a potentially recurrent cause of coma (tumours, infectious diseases with risk of relapse and inflammatory diseases)
- •Moribund patient (life expectancy \< 24h) or in WLST (no assessment possible of the dynamics of ongoing awakening)
- •Haemodynamic or respiratory instability incompatible with a prolonged attempt to stop sedation (except in the case of scheduled surgery outside the visit dates)
- •Patients under guardianship, curatorship or safeguard of justice
- •Patients not affiliated to the French health insurance system
- •Pregnant women or women of childbearing age without proof of the absence of a current pregnancy
Arms & Interventions
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Repeated behavioural assessment
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Act-Pass paradigm
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Biological measures of circadian and monoamines biomarkers
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Transcriptomic and genomic analysis
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Polysomnography with concomitant environment recording
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Actimetry
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Morphological MRI
Main group with acute brain injury and initial Disorders of consciousness
50 patients in the initial phase of acute brain injury with disturbed consciousness, hospitalized in the Neurological Intensive Care Unit and at risk of delayed awakening
Intervention: Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Repeated behavioural assessment
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Act-Pass paradigm
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Biological measures of circadian and monoamines biomarkers
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Transcriptomic and genomic analysis
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Polysomnography with concomitant environment recording
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Actimetry
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Morphological MRI
Comparative group with acute brain injury without Disorders of consciousness
20 patients in the initial phase of brain damage WITHOUT disturbance of consciousness, hospitalized in the Neurological Intensive Care Unit and presenting similar causes of brain damage.
Intervention: Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Repeated behavioural assessment
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Act-Pass paradigm
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Biological measures of circadian and monoamines biomarkers
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Transcriptomic and genomic analysis
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Polysomnography with concomitant environment recording
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Actimetry
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Morphological MRI
Comparative group with post-acute Disorders of consciousness
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Intervention: Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.
Outcomes
Primary Outcomes
Consciousness outcome
Time Frame: 2, 3, 4,6 months post injury
Coma Recovery Scale - revised used to define 4 possible consciousness outcomes (the best observed before death if the patient died at the date of assessment): * Coma * Unresponsive Wakefulness Syndrome * Minimally Conscious State * Exit-Minimally Conscious State (conscious patient)
Secondary Outcomes
- Quality of life outcome SF-36 scale(6 months post injury)
- Functional outcome(GOS: 2, 3, 4,6 months post injury GOSE: 6 months post injury)
- Cognitive outcome(6 months post injury)