Circadian Rhythmicity During Coma Awakening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Repeated behavioural assessment
  • Act-Pass paradigm
  • Biological measures of circadian and monoamines biomarkers
  • Transcriptomic and genomic analysis
  • Polysomnography with concomitant environment recording
  • Actimetry
  • Morphological MRI
  • Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators