Actively Recruiting
Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-05-23
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
R
Research Foundation Flanders
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating brain activity patterns and seizure dynamics in patients with acute brain injury who have impaired consciousness. The study aims to better understand the neural networks involved in consciousness and improve diagnostic and prognostic tools during intensive care. It focuses on overcoming limitations of current EEG monitoring by using advanced intracranial electrodes for more precise brain activity measurement. Participants undergo placement of intracranial electrodes in the cortico-subcortical system to continuously monitor brain signals with high spatial and temporal resolution. This setup enables detection of seizures and study of thalamocortical network behavior in unresponsive patients. The study observes effects of brain stimulation and tracks neural profiles over time, including during the first 4 weeks after electrode implantation. During the study, participants receive continuous brain monitoring and behavioral assessments using the Coma Recovery Scale-Revised. Researchers measure seizure activity through intracranial and scalp EEG, analyze neural complexity, and evaluate responses to electrical stimulation. Long-term outcomes are assessed at 6 months and 1 year. The study supports improved patient stratification and may inform future treatments to aid recovery of consciousness.
CONDITIONS
Brief Title
Connectivity and Neural Signatures of Consciousness in Unresponsive States
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Brain injury of any kind, with impaired consciousness or suspected seizures
You will not qualify if you...
- Under 18 years old
- Known pregnancy
- Any condition that makes participation unsafe or unfeasible, such as irreversible coagulopathy, large intracranial tumors, or surgical technical problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks after electrode implantation
Participants with acute brain injury and reduced consciousness undergo placement of intracranial electrodes for multimodal monitoring.
Continuous monitoring during hospital stay with intracranial electrodes
Duration - 6 months to 1 year
Participants are followed up to assess neural activity profiles correlated with behavioral responsiveness and long-term outcomes.
Follow-up visits at 6 months and 1 year
Trial Site Locations
Total: 1 location
1
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
S
Steven Smeijers, MD
T
Tom Theys, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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