An interventional study of Repeated behavioural assessment and Act-Pass paradigm in Acute Brain Injury Coma, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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.
Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Group 1
Group 2
Absence of severe disorder of consciousness but possibility of minimal alteration of the initial Glasgow score (GCS between 9 and 15) with no time limit, with a stratification of three consecutive patient populations distinguished by the initial neurological alteration:
Group 3
Disturbance of consciousness defined by an absence of communication or an absence of functional use of objects (for patients with aphasia), i.e. the two signs that could indicate emergence from the pauci-relational state, which includes patients presenting :
Persistent within the following timeframe
Exclusion Criteria:
Group 1
Group 2
Epileptic seizures on admission or during the stay
Group 3
Epileptic seizures during the week preceding inclusion:
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
Behavioral: Repeated behavioural assessment · Behavioral: Act-Pass paradigm · Behavioral: Biological measures of circadian and monoamines biomarkers · Behavioral: Transcriptomic and genomic analysis · Behavioral: Polysomnography with concomitant environment recording · Behavioral: Actimetry · Behavioral: Morphological MRI · Behavioral: Assessment of correlation between patients' behaviour and neurophysiological markers 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.
Behavioral: Repeated behavioural assessment · Behavioral: Act-Pass paradigm · Behavioral: Biological measures of circadian and monoamines biomarkers · Behavioral: Transcriptomic and genomic analysis · Behavioral: Polysomnography with concomitant environment recording · Behavioral: Actimetry · Behavioral: Morphological MRI · Behavioral: Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.
20 patients in the sub-acute or chronic phase of a consciousness disorder and admitted to the Post-Resuscitation Rehabilitation Service.
Behavioral: Repeated behavioural assessment · Behavioral: Act-Pass paradigm · Behavioral: Biological measures of circadian and monoamines biomarkers · Behavioral: Transcriptomic and genomic analysis · Behavioral: Polysomnography with concomitant environment recording · Behavioral: Actimetry · Behavioral: Morphological MRI · Behavioral: Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.
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.
Consciousness 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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Hospices Civils de Lyon