Investigating brain activity and consciousness in patients with severe brain injuries
Official title: Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness
Run by Universitaire Ziekenhuizen KU Leuven · NCT06426615 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 23, 2024 |
| Trial ID | NCT06426615 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies utilizing intracranial monitoring techniques have shown promise in understanding consciousness and seizure dynamics, suggesting a potential for success in this approach.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.