Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness

Phase

N/A

Condition

Traumatic Brain Injury

Meningitis

Stroke

Treatment

N/A

Clinical Study ID

NCT06283901

NL82013.018.22

Ages > 18
All Genders

Study Summary

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria: All patients that are admitted to the ICU with the following criteria will be eligible forinclusion:

Severe brain injury (GCS ≤ 8) as a result of:
Traumatic brain injury
Ischemic cerebrovascular accident
Intracranial hemorrhage
Meningo-encephalitis
Subarachnoid hemorrhage
Age ≥ 18 years old
Written informed consent from legal representatives

Exclusion

Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded fromparticipation in this study:

Absence of informed consent
Moribund at ICU admission
Progressive neurodegenerative disease
Pre-admission life expectancy ≤ 6 months based on comorbidity
GCS has been > 8 prior to inclusion
Impossible to include within 24 hours after brain injury

Study Design

January 02, 2023

September 01, 2025

Study Description

In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.

Clinical rating scales

Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score
Once a week

Blood biomarkers

Neuron specific enolase, neurofilament light, glial fibrillary acidic protein
Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury
Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C

EEG with reactivity testing

Standard 21-electrode montage
Stimuli protocol I: a set of 5 stimuli repeated 3 times
1. Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds
Stimuli protocol II: Cognitive-motor dissociation test

MRI-scan

Sequences considered essential for patient care i.e.T1, T2, FLAIR, DWI/SWI
Preferably, performed between 4-6 weeks after hospital admission

Connect with a study center

Radboud UMC
Nijmegen, Gelderland 6525 GA
Netherlands
Active - Recruiting
Amsterdam UMC
Amsterdam, Noord-Holland 1105 AZ
Netherlands
Active - Recruiting
Haaglanden MC, locatie Westeinde
Den Haag, Zuid-Holland 2512 VA
Netherlands
Active - Recruiting
Erasmus MC
Rotterdam, Zuid-Holland 3015 GD
Netherlands
Site Not Available
UMC Groningen
Groningen, 9713 GZ
Netherlands
Site Not Available

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