Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer
Bron, Lyon, 69500, France
Location status: Recruiting
NCT Number: NCT06245434
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.
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Request Info17 year and older
All sexes
Interventional
Not applicable
Bron, Lyon, 69500, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group 1
Group 2
Group 3
Exclusion criteria
Group 1
Group 2
Group 3
One CRS-R per visit
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.
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):
Time frame: GOS: 2, 3, 4,6 months post injury GOSE: 6 months post injury
Glasgow Outcome Scale (GOS) Glasgow Outcome Scale Extended (GOSE)
Minimum score 1 and maximum score 5. The lowest score is 5.
Time frame: 6 months post injury
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
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)
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Acronym: COMARHYTHM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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Acute Brain Injury Coma, Brain Diseases
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