Circadian Rhythmicity During Coma Awakening

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 2, 2024

Primary Completion Date

February 15, 2028

Study Completion Date

February 15, 2028

Conditions
Acute Brain Injury Coma
Interventions
BEHAVIORAL

Repeated behavioural assessment

"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"

BEHAVIORAL

Act-Pass paradigm

Before and after sedation withdrawal Assessment of infra-clinical response to an active paradigm (attention focalisation or diversion).

BEHAVIORAL

Biological measures of circadian and monoamines biomarkers

Systematic urinary sampling every 2 hours for melatonin, cortisol and monoamines metabolites

BEHAVIORAL

Transcriptomic and genomic analysis

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

BEHAVIORAL

Polysomnography with concomitant environment recording

"One 48h polysomnography for the first visit~\+ 3\* 24h polysomnography for each visit Synchronised recordings of light, sound, activity in patients' rooms"

BEHAVIORAL

Actimetry

Continuous recording of movements at the wrist during 7 days after sedation withdrawal

BEHAVIORAL

Morphological MRI

Precise description of brain lesion by a 3T MRI within the 1st week after sedation withdrawal

BEHAVIORAL

Assessment of correlation between patients' behaviour and neurophysiological markers of consciousness.

Video recording of spontaneous patients' movements in the bed and synchronized during 2h with high-density EEG.

Trial Locations (1)

69500

RECRUITING

Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer, Bron

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER