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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
90
One CRS-R per visit * 4 SECONDs * Eye tracking during every clinical assessment * Recording every 2-4h of the Glasgow Coma Score * Recording every 2h of the temperature and pupillometer reactivity to light
Before and after sedation withdrawal Assessment of infra-clinical response to an active paradigm (attention focalisation or diversion).
Systematic urinary sampling every 2 hours for melatonin, cortisol and monoamines metabolites
Definition of the peripheral cellular clock by 2 transcriptomic measures Constitution of a genomic biobank to analyse the cofounding factors for circadian disruption and differential clinical recovery
One 48h polysomnography for the first visit \+ 3\* 24h polysomnography for each visit Synchronised recordings of light, sound, activity in patients' rooms
Continuous recording of movements at the wrist during 7 days after sedation withdrawal
Precise description of brain lesion by a 3T MRI within the 1st week after sedation withdrawal
Video recording of spontaneous patients' movements in the bed and synchronized during 2h with high-density EEG.
Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer
Bron, Lyon, France
RECRUITINGConsciousness outcome
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)
Time frame: 2, 3, 4,6 months post injury
Functional outcome
Glasgow Outcome Scale (GOS) Glasgow Outcome Scale Extended (GOSE) Minimum score 1 and maximum score 5. The lowest score is 5.
Time frame: GOS: 2, 3, 4,6 months post injury GOSE: 6 months post injury
Cognitive outcome
MOCA scale The MOCA is a short 30-question test that assesses several cognitive domains and allows for early detection of cognitive disorders. The MOCA test takes about 10-15 minutes to administer and consists of several sections, the first of which is an assessment of orientation in time and space. Then there are tasks that assess memory, concentration and reasoning ability, as well as language and visuospatial ability tasks. The MOCA score can range from 0 to 30 points, with a score of 26 points or more considered normal.
Time frame: 6 months post injury
Quality of life outcome SF-36 scale
At the end, a score for each dimension of the SF-36 was calculated, ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, absence of functional deficit, and pain (3,6,7)
Time frame: 6 months post injury
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