Investigating brain activity and consciousness in patients with severe brain injuries
Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness
This study is testing a new way to monitor brain activity in patients with severe brain injuries to see if it can help doctors understand their level of consciousness and improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06426615 on ClinicalTrials.gov |
What this trial studies
The CONSCIUS study is an interventional study focusing on patients with acute brain injuries who have impaired consciousness. It involves the implantation of intracranial electrodes to monitor and analyze neural dynamics and seizures in these patients. The goal is to develop objective measures that can predict recovery of consciousness and improve treatment decisions in intensive care settings. By utilizing continuous EEG monitoring with high spatial and temporal resolution, the study aims to enhance our understanding of the thalamocortical mechanisms underlying consciousness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have sustained any type of brain injury and exhibit impaired consciousness or suspected seizures.
Not a fit: Patients under 18 years old, pregnant individuals, or those with conditions deemed unsafe for participation by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for assessing consciousness recovery in patients with severe brain injuries.
How similar studies have performed: Other studies utilizing intracranial monitoring techniques have shown promise in understanding consciousness and seizure dynamics, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old or older * Brain injury of any kind, with impaired consciousness or suspected seizures Exclusion Criteria: * \< 18 years old * Known pregnancy * Any condition that, in the judgement of the investigator, makes participation in the study unsafe or unfeasible (e.g., irreversible coagulopathy, large intracranial tumors, surgical technical problems…)
Where this trial is running
Leuven, Vlaams-Brabant
- UZLeuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Tom Theys, MD PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Steven Smeijers, MD
- Email: steven.smeijers@uzleuven.be
- Phone: +32 16 34 48 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.