Informations générales (source: ClinicalTrials.gov)
Longitudinal Evaluation of Circadian and Ultradian Rhythmic Fluctuations Measured by Continuous EEG During Coma to Predict the Recovery of Consciousness (FR2)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2020
juin 2021
29 juin 2024
BRIEF SUMMARY :
In the most severe cases of brain injuries, intensive care may allow patients with
altered consciousness to survive despite a significant risk of heavy sequelae. Persistent
impairments of consciousness are currently categorized according to behavior in three
main neurological categories: comatose state, vegetative state (recently named
unresponsive wakefulness syndrome) and minimally conscious state. Refining the diagnosis
of internal state is a major goal to determine the abilities for an optimal recovery of
cognitive deficit. Circadian rhythms are implicated in the regulation of sleep-wake
cycles but also in cognitive functions. Their role is actually revaluated in the
mechanisms of consciousness impairment. First, it is well known that cognitive
performances partially depend on such rhythms as they are more elevated during the day
and correlated to the hormonal secretion. In a prognostic point of view, fewer rhythmic
perturbations during the initial resuscitation period (with reorganized sleep rhythms and
the presence of paradoxical sleep) could be associated to a higher functional outcome.
However, this internal state of alertness could be highly variable during the day as it
might be influenced by specific rhythms such as the circadian rhythm. Only a continuous
assessment could help defining them properly.
Thus, investigators hypothesize that the circadian restauration, assessed in a dynamic
perspective, is associated with the improvement of content and level of awareness. The
main challenge of our study is to capture the long-term changes in the evolution of
circadian and ultradian rhythms and to keep a part of the natural history of the clinical
recovery of these patients.
To achieve this goal, the investigators plan to analyze during more than 2 days both
neurophysiological rhythms (EEG) and behavioral rhythms of alertness ("Eyes" scale from
of the Glasgow coma scale) in a dataset collected retrospectively from the population of
patients continuously monitored by EEG for medical purposes (to identify seizures and
prevent status epilepticus) in an intensive care unit of teaching hospital as far as
acquisitions last more than 48h and present no prolonged epileptic discharges or
artifacts leading to uninterpretable EGG.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Lyon teaching hospital, Hospices Civils de Lyon - Lyon - France | Florent GOBERT | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patient
- Admitted in ICU
- Altered level of consciousness not explained by a continuous sedation
- EEG during more than 48h consecutively
- Adult patient
- Admitted in ICU
- Altered level of consciousness not explained by a continuous sedation
- EEG during more than 48h consecutively
- Prolonged epileptic discharges leading to uninterpretable EEG rhythms
- Prolonged artifacts leading to uninterpretable EEG trace