- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06089538
Electrophysiological Signatures of Cognitive Disorders Related to Intensive Care Unit (ICU) delirium_ BRAINSTORM-EEG (B-EEG)
October 12, 2023 updated by: University Hospital, Toulouse
Electrophysiological Signatures of Cognitive Disorders Related to ICU Delirium : a Pilot Study
Early cognitive assessment of critically-ill acute respiratory distress syndrome (ARDS) patients with delirium using a multidimensional electrophysiological evaluation battery (mEEG) to identify and characterize the neural correlates of cognitive dysfunctions associated with delirium (vigilance, attention, semantic and lexical processing, self-processing), and to develop a prognostic evaluation of neurocognitive and psychological disorders using an innovative non-behavioral approach.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Delirium is an altered mental status associated with specific manifestations such as reduced ability to direct, focus, maintain and shift attention Diagnostic Medical Systems V criteria (DSM).
The vulnerability of critically-ill acute respiratory distress syndrome (ARDS) patients explains the high incidence of delirium (up to 80%) in this setting.
Delirium is an independent predictor of post-traumatic stress disorder, long term cognitive decline and mortality.
To reduce this medical and social burden, a more complete description of delirium is needed both in terms of cognitive impairments and long term neurological and neuropsychological impact.
Actually, it could be argued that the current exclusive behavioral assessment of these patients is insufficient in terms of diagnosis and prognostic assessment.
In recent years, the study of consciousness has made major progress thanks to the use of innovative electrophysiological exploration methods.
This work has notably allowed the development of new non-behavioral tools for the exploration of brain function in brain damaged patients in response to complex auditory stimulations (multidimensional electrophysiological battery, mEEG).
In this context, the investigators have recently demonstrated alterations in cognitive functions related to language- and self-processing in acute respiratory distress syndrome (ARDS) patients with severe acute respiratory syndrome (SARS) - COVID-19 infection.
These electrophysiological cognitive alterations were particularly marked in COVID-19 patients with delirium.
Further studies are needed to disentangle the cognitive impact specifically related to delirium from that related to a severe form of COVID-19.
The primary objective of this study is to identify diagnostic electrophysiological signatures of cognitive dysfunctions associated with the acute phase of delirium in critically-ill acute respiratory distress syndrome (ARDS) patients using a multidimensional electrophysiological assessment (mEEG) recording at rest and during auditory stimulation (first visit).
Secondary objectives are to characterize the impact of intensive care unit (ICU)-related delirium on neurocognitive and psychological dysfunctions observed at 6 months (second visit), in order to explore the prognostic predictive value of electrophysiological data acquired during the acute phase of delirium.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William BUFFIERES, MD
- Phone Number: +33 561779435
- Email: buffieres.w@chu-toulouse.fr
Study Locations
-
-
-
Toulouse, France, 31000
- University Hospital of Toulouse
-
Contact:
- William BUFFIERES, MD
- Phone Number: +33 561779435
- Email: buffieres.w@chu-toulouse.fr
-
Principal Investigator:
- William BUFFIERES, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients admitted to the intensive care unit with ARDS (according to Berlin criteria)
- Membership of a social security scheme
- Signed consent of the patient (group without delirium) or referring person (group with delirium)
- Discontinuation of any sedative agent for ≥ 72 hours
Exclusion Criteria:
- Pre-existing psychotic disorders
- Pre-existing cognitive deficits
- Patients with chronic ethylism
- Previous neurological history
- Recent ICU admission (> 5 days of ICU hospitalization within 6 months prior to current ICU admission)
- Patients whose delirium cannot be reliably assessed due to blindness, deafness or inability to speak French
- Patients whose life expectancy is unlikely to exceed 24 hours
- Pregnant women
- Patients under court protection
- Patients who have already participated in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Delirium patients group
Patients admitted for acute respiratory distress syndrome (ARDS) who developed delirium
|
The 2 groups will be assessed twice : in the acute phase of acute respiratory distress syndrome (ARDS) at patient's bedside in the intensive care unit (ICU) using an mEEG battery (electrophysiological acquisition at rest and during complex cognitive stimulation), and a simple clinical neuropsychological assessment ; 6 months ± 2 weeks later using the same mEEG battery and a multi-domain clinical neurocognitive and psychological assessment battery
|
Active Comparator: Patients without delirium
Patients admitted for acute respiratory distress syndrome (ARDS) who did not developed delirium
|
The 2 groups will be assessed twice : in the acute phase of acute respiratory distress syndrome (ARDS) at patient's bedside in the intensive care unit (ICU) using an mEEG battery (electrophysiological acquisition at rest and during complex cognitive stimulation), and a simple clinical neuropsychological assessment ; 6 months ± 2 weeks later using the same mEEG battery and a multi-domain clinical neurocognitive and psychological assessment battery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by presence or absence of the signal
|
Baseline
|
Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)
|
Baseline
|
Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)
|
Baseline
|
Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) six months after phase of delirium
Time Frame: 6 months
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by presence or absence of the signal
|
6 months
|
Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: 6 months
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)
|
6 months
|
Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: 6 months
|
Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William BUFFIERES, MD, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 30, 2023
Primary Completion (Estimated)
June 20, 2025
Study Completion (Estimated)
June 20, 2025
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
October 12, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/22/0526
- 2023-A00935-40 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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