An interventional study of Intracranial electrodes in Acute Brain Injury, Traumatic Brain Injury and Consciousness Disorders, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic
The CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness.
Individuals with severe brain injury often require extensive treatment in intensive care units (ICU) and hospitalization wards while uncertainty prevails about the recovery of consciousness and cognitive abilities. Especially in the acute phase after injury, treatment decisions have a tremendous impact on outcome, but rely on assessments of behavioral responsiveness which are known to be unreliable and subject to many confounders. Objective, quantifiable diagnostic and prognostic measures that can be deployed at the bedside during the ICU stay are lacking. Development of new metrics are hampered by our lack of a fundamental understanding of (i) thalamocortical network mechanisms underlying consciousness and (ii) brain-injury induced neural dynamics impacting both consciousness and outcome. Continuous EEG monitoring has been used to aid in this respect to (i) predict recovery of consciousness and outcome, and (ii) diagnose nonconvulsive seizures in unresponsive patients. Although promising, it lacks sensitivity, spatial resolution, and causal power. There is an urgent need for techniques allowing high-precision detection of pathological dynamics, patient stratification and prediction of a capacity for consciousness recovery in acute unresponsive patients with brain injury. Intracranial electrodes as part of multimodal monitoring in subjects with impaired consciousness and severe brain injury allow continuous bedside recordings of high spatiotemporal resolution in different network nodes and allows inducing brain perturbations, transcending correlational evidence of network analysis. This technique could increase the detection and treatment of nonconvulsive seizures contributing to brain injury and unresponsiveness and simultaneously allows to study networks supporting consciousness. This can lead to new diagnostic and prognostic biomarkers for recovery based on thalamocortical profiles of activity, reactivity (complexity) and connectivity, ultimately paving to way for the development of biomarker-driven treatments to support early recovery such as deep brain stimulation. Eventually this can contribute to clinical decision making: abstaining from aggressive treatment in patients with no potential for recovery, and more importantly, continuing treatment in subjects with a responsive brain but without clear behavioural correlate.
2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's planned enrollment of 20 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients with acute brain injury with reduced consciousness that undergo multimodal intracranial monitoring, or with suspected seizures
Device: Intracranial electrodes
Placement of intracranial electrodes in the cortico-subcortical system
Also known as: Depth electrodes
Incidence of electrographic epileptiform activity (ictal and ictal-interictal continuum activity) on intracranial versus scalp electroencephalography (EEG).
The primary aim is to compare the incidence of ictal and ictal-interictal continuum epileptiform activity on intracranial versus scalp EEG.
Time frame: A maximum of 4 weeks after electrode implantation.
Correlating neural activity patterns (local field potentials and complexity) with behavioral responsiveness (measured using the Coma Recovery Scale-Revised).
Correlation of profiles of neural activity and reactivity with the behavioral state using the Coma Recovery Scale-Revised (CRS-R).
Time frame: A maximum of 4 weeks after electrode implantation.
Acute effects of electrical stimulation on behavioral responsiveness (measured using the Coma Recovery Scale-Revised).
Effects of electrical stimulation on behavioral responsiveness will be measured using the Coma Recovery Scale Revised (CRS-R).
Time frame: During electrical stimulation trials, performed in the first 4 weeks after electrode implantation.
Correlation of neural activity profiles with long-term outcome (Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended)
Profiles of activity and reactivity identified during the acute stage of the disease will be correlated with long-term outcome measures mainly at 6m and 1y, using Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended.
Time frame: At 6 months and 1 year follow-up.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 566 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 47 months is above that.
Counting every sponsor, half of 599 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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