Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426615
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-29
Brief Title:
Connectivity and Neural Signatures of Consciousness in Unresponsive States
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Connectivity and Neural Signatures of Consciousness In Unresponsive States CONSCIUS - a Study of Brain Activity in Disorders of Consciousness
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONSCIUS
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None