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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult.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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)

NCT04687397

Consciousness Disorder Brain Injuries

COMPLETED

Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness

NCT05802524

Consciousness Disorder Cognitive Impairment

COMPLETED

Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient

NCT03023657

Consciousness Disorder

TERMINATED NA

Spontaneous Eye Blinking in Disorders of Consciousness

NCT06323031

Disorders of Consciousness

RECRUITING

Cognitive Function Assessment in Patients With Focal Brain Injury

NCT04182087

Focal Brain Injury Cognition

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Intracranial Hemorrhages Subarachnoid Hemorrhage Meningitis Encephalitis Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:

1. Severe brain injury (GCS ≤ 8) as a result of:

1. Traumatic brain injury
2. Ischemic cerebrovascular accident
3. Intracranial hemorrhage
4. Meningo-encephalitis
5. Subarachnoid hemorrhage
2. Age ≥ 18 years old
3. Written informed consent from legal representatives

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No