ComaFR2NCT04444648
Fluctuation of Rhymicity to Predict Recovery
An observational study of Coma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comatose patient in ICU under intermittent behavioural evaluation and continuous EEG recording.
Who may be able to join
- Adult patient
- Admitted in ICU
- Altered level of consciousness not explained by a continuous sedation
- EEG during more than 48h consecutively
Who cannot join
- Prolonged epileptic discharges leading to uninterpretable EEG rhythms
- Prolonged artifacts leading to uninterpretable EEG trace
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lyon teaching hospital, Hospices Civils de Lyon
Lyon
Florent GOBERT, 0472681296, florent.gobert01@chu-lyon.fr
About this study
Official title: Longitudinal Evaluation of Circadian and Ultradian Rhythmic Fluctuations Measured by Continuous EEG During Coma to Predict the Recovery of Consciousness
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.
Read more
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.
- Conditions
- Coma
- Being tested
- No intervention
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionCombination product
No intervention
| Study group | Role | What they receive |
|---|---|---|
| One groupe without distinction of age, sexe, and pathology. | Patients with strok in coma, with or without wake up, and with disorder of consciousness. No limit in age (maybe give the younger age).
We obtain this data from medical record. Every assessment was made of clinical purposes.
We use the Glasgow coma recovery scale for assessment of behavior to check the variation of wakefulness. The scale was performed by the nursing staff every 2 to 8 hours depending on the severity of the medical condition.
The continuous analysis of neurophysiologic data was based on EEG with a bipolar montage composed of the less noisy electrodes per recording period.
The EEG features will include: spectral analysis (relative and absolute power in 4 canonical bands: Delta/Theta/Alpha/Beta) and complexity analysis (DFA, determinism, SVD entropy and permutation entropy).
The patient outcome at the ICU and hospital discharges were collected from the medical files. Receives: Combination Product: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of awakening at the end of the period in the hospital
The final outcome to assess the respective predictive value of behavioural assessment in ICU and EEG assessment of circadian and ultradian rhythms will be obtained by the medical record when the patient leave the hospital using a unique functional scale, namely the GOSE (Glasgow Outcome Scale - Extended).
We use the Glasgow coma recovery scale for assessment of behavior to check the variation of wakefulness. The scale was performed by the nursing staff every 2 to 8 hours depending on the severity of the medical condition.
The continuous analysis of neurophysiologic data was based on EEG with a bipolar montage composed of the less noisy electrodes per recording period.
The patient outcome at the ICU and hospital discharges were collected from the medical files.
Measured: We analyze data obtained in a period between 2014 to 2017. The analysis is made since January 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start24 Jan 2020
- Primary completion24 Jan 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444648
- Sponsor's protocol ID
- FR2
- Acronym
- FR2
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Circadian and Ultradian Rhythmic Fluctuations Measured by Continuous EEG During Coma to Predict the Recovery of Consciousness
- ClinicalTrials.gov ID
- NCT04444648
- Acronym / sponsor ID
- FR2 / FR2
- Conditions
- Coma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One groupe without distinction of age, sexe, and pathology. | – | Combination Product: No interventionPatients with strok in coma, with or without wake up, and with disorder of consciousness. No limit in age (maybe give the younger age). We obtain this data from medical record. Every assessment was made of clinical purposes. We use the Glasgow coma recovery scale for assessment of behavior to check the variation of wakefulness. The scale was performed by the nursing staff every 2 to 8 hours depending on the severity of the medical condition. The continuous analysis of neurophysiologic data was based on EEG with a bipolar montage composed of the less noisy electrodes per recording period. The EEG features will include: spectral analysis (relative and absolute power in 4 canonical bands: Delta/Theta/Alpha/Beta) and complexity analysis (DFA, determinism, SVD entropy and permutation entropy). The patient outcome at the ICU and hospital discharges were collected from the medical files. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comatose patient in ICU under intermittent behavioural evaluation and continuous EEG recording.
Key inclusion criteria (4 listed)
- Adult patient
- Admitted in ICU
- Altered level of consciousness not explained by a continuous sedation
- EEG during more than 48h consecutively
Key exclusion criteria (2 listed)
- Prolonged epileptic discharges leading to uninterpretable EEG rhythms
- Prolonged artifacts leading to uninterpretable EEG trace
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Combination product | One groupe without distinction of age, sexe, and pathology. |
Primary outcome
Status of awakening at the end of the period in the hospital
Time frame: We analyze data obtained in a period between 2014 to 2017. The analysis is made since January 2020.
The final outcome to assess the respective predictive value of behavioural assessment in ICU and EEG assessment of circadian and ultradian rhythms will be obtained by the medical record when the patient leave the hospital using a unique functional scale, namely the GOSE (Glasgow Outcome Scale - Extended). We use the Glasgow coma recovery scale for assessment of behavior to check the variation of wakefulness. The scale was performed by the nursing staff every 2 to 8 hours depending on the severity of the medical condition. The continuous analysis of neurophysiologic data was based on EEG with a bipolar montage composed of the less noisy electrodes per recording period. The patient outcome at the ICU and hospital discharges were collected from the medical files.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florent GOBERT (0472681296, florent.gobert01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of awakening at the end of the period in the hospital (time frame: We analyze data obtained in a period between 2014 to 2017. The analysis is made since January 2020.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.