Loading clinical trials...
Loading clinical trials...
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.
Age
17 - No limit years
Sex
ALL
Healthy Volunteers
No
Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer
Bron, Lyon, France
Start Date
December 2, 2024
Primary Completion Date
December 2, 2028
Completion Date
December 2, 2028
Last Updated
February 6, 2026
90
ESTIMATED participants
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.
BEHAVIORAL
Lead Sponsor
Hospices Civils de Lyon
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions