Disorders of Consciousness Due to Severe Brain Injury
Conditions
Brief summary
The goal of this observational study is to determine whether the clinical response to olfactory stimulation (known as the sniff response) can help predict 3-month neurological outcomes in ICU patients with persistent disorders of consciousness after sedation withdrawal, regardless of the reason for admission or the initial severity. The main questions this study aims to answer are: * Can the sniff response to olfactory stimulation predict neurological outcomes at 3 months? * Is this response a better prognostic indicator than commonly used neurophysiological tests? Researchers will compare the results obtained from olfactory stimulation with those from somatosensory and auditory stimulations to determine whether the olfactory method provides additional or superior prognostic value. Participants will receive additional olfactory stimuli as part of the neurophysiological evaluation for prognostic purposes and be followed up at 3 months for clinical, neurological, and functional evaluation
Interventions
DIAGNOSTIC_TESTOlfactory stimulation
Olfactory stimulation (sniff test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients.
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admission to neuro-intensive care unit (neuro-ICU) * Age ≥ 18 years * Patients with persistent disorders of consciousness defined by an abnormal CRS-R score (\<16) at 72 hours after sedation withdrawal and spontaneous ventilation * Consent obtained from legal representatives or activation of emergency waiver * Patient covered by or affiliated with a social security system
Exclusion criteria
* Pregnancy * Brain death * Pre-existing ENT or olfactory bulb pathologies that may affect olfactory functions * Acute or chronic peripheral neurological diseases that may alter evoked potentials * Known neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease) * Patients under legal guardianship or protective supervision (safeguard or protection measures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale-Extended (GOS-E) score at 3 months | 3 months after inclusion |
Countries
France
Contacts
Primary ContactEleonore BOUCHEREAU, MD, PhD
Outcome results
None listed