Cognitive DysfunctionB-EEGNCT06089538
Electrophysiological Signatures of Cognitive Disorders Related to Intensive Care Unit (ICU) delirium_ BRAINSTORM-EEG
A study testing mEEG battery in people with Cognitive Dysfunction, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- mEEG battery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2024to 25 Feb 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Patients whose life expectancy is unlikely to exceed 24 hours
- Pregnant women
- Patients under court protection
- Patients who have already participated in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- mEEG battery
- Keywords
- delirium, acute respiratory distress syndrome (ARDS), P300, N400, self-processing, semantic priming, functional connectivity
- Medical subject headings
- Cognitive Dysfunction, Delirium, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mEEG batteryDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Delirium patients group | Experimental | Patients admitted for acute respiratory distress syndrome (ARDS) who developed delirium Receives: Diagnostic Test: mEEG battery |
| Patients without delirium | Active comparator | Patients admitted for acute respiratory distress syndrome (ARDS) who did not developed delirium Receives: Diagnostic Test: mEEG battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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
Measured: Baseline
Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)
Measured: Baseline
Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)
Measured: Baseline
Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) six months after phase of delirium
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
Measured: 6 months
Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)
Measured: 6 months
Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start21 May 2024
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William BUFFIERES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089538
- Sponsor's protocol ID
- RC31/22/0526
- Other IDs
- 2023-A00935-40
- Acronym
- B-EEG
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Signatures of Cognitive Disorders Related to ICU Delirium : a Pilot Study
- ClinicalTrials.gov ID
- NCT06089538
- Acronym / sponsor ID
- B-EEG / RC31/22/0526
- Conditions
- Cognitive Dysfunction
- Keywords
- delirium, acute respiratory distress syndrome (ARDS), P300, N400, self-processing, semantic priming, functional connectivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 18 Oct 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium patients group | Experimental | Diagnostic Test: mEEG batteryPatients admitted for acute respiratory distress syndrome (ARDS) who developed delirium |
| Patients without delirium | Active comparator | Diagnostic Test: mEEG batteryPatients admitted for acute respiratory distress syndrome (ARDS) who did not developed delirium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| mEEG batteryThe 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 | Diagnostic test | Delirium patients group, Patients without delirium |
Primary outcome
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
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)
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)
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
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)
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)
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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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.
William BUFFIERES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mEEG battery in people with Cognitive Dysfunction, run by University Hospital, Toulouse 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 10 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: stopped early, as of the sponsor's last update on 29 Oct 2026. 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?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. 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 29 Oct 2026.