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

Cognitive Dysfunction Clinical Trial

— B-EEG  

Official title:

Electrophysiological Signatures of Cognitive Disorders Related to ICU Delirium : a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089538
• Other study ID #: RC31/22/0526
• Secondary ID: 2023-A00935-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: June 20, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: William BUFFIERES, MD
• Phone: 561779435
• Email: buffieres.w[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Delirium

Intervention

Diagnostic Test:
• mEEG battery
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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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)	Baseline
Primary	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)	Baseline
Primary	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	6 months
Primary	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)	6 months
Primary	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)	6 months