Monitoring brain activity and drug effects in patients with severe brain injuries
Multimodal Neuromonitoring: an Explorative Study in Neurocritical Care Patients
This study is trying to see how different ways of monitoring brain activity can help doctors understand the effects of medications on patients with severe brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04737369 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on multimodal neuromonitoring to assess brain activity and metabolic demand in patients with severe brain injuries such as subarachnoid hemorrhage, intracerebral hemorrhage, and traumatic brain injury. It employs both invasive and noninvasive techniques, including electrocorticography and continuous EEG, to monitor critical electrophysiological phenomena like cortical spreading depressions and seizures. The study aims to correlate these measurements with cerebral ischemia and drug concentrations to better understand their impact on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with severe brain injuries who are unlikely to regain consciousness within 48 hours but are expected to survive that duration.
Not a fit: Patients younger than 18 or older than 80, pregnant women, or those who do not wish to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and management of brain injuries, potentially enhancing patient recovery and outcomes.
How similar studies have performed: While multimodal neuromonitoring is a growing field, this specific approach is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies \>3), severe ICH (ICH Score \>3) or severe TBI (Glasgow Coma Scale \< 9). The diagnosis of SAH, ICH and TBI will be established by computed tomography (CT). * Individuals that are unlikely to regain consciousness within the following 48 hours. * Individuals that are expected to survive for the next 48 hours. Exclusion Criteria: * Individuals younger than 18 years old and older than 80 years. * Pregnant women (documented via positive ß-HCG test). * Patients, who do not want to participate in the study. As the patient is not able to consent prior to the study, information about the study details will be given to the patient in case of clinical improvement. The patient information sheet will be handed out. Thereafter, the patient has the possibility to withdraw permission of study-participation.
Where this trial is running
Vienna
- Department of Neurosurgery, Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Johannes Herta, MD PhD — Department of Neurosurgery, Medical University of Vienna
- Study coordinator: Johannes Herta, MD PhD
- Email: johannes.herta@meduniwien.ac.at
- Phone: +43 (0)1 40400-25770
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.