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Electrophysiological Signatures of Cognitive Disorders Related to Intensive Care Unit (ICU) delirium_ BRAINSTORM-EEG

France60 participantsStarted 2023-10-30

Plain-language 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 and lexical processing, self-processing), and to develop a prognostic evaluation of neurocognitive and psychological disorders using an innovative non-behavioral approach.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) six months after phase of delirium

Timeframe: 6 months

Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: 6 months

Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: 6 months

Trial details

NCT IDNCT06089538

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-20

Contact for this trial

William BUFFIERES, MD

561779435 buffieres.w@chu-toulouse.fr

View on ClinicalTrials.gov More Cognitive Dysfunction trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) six months after phase of delirium

Timeframe: 6 months

Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: 6 months

Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: 6 months