Impact of status epilepticus on human brain structure and function Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with SE 1. Adults with SE admitted to the participating centers 2. Signed consent form (mandatory) 3. Capable of understanding the information provided both cognitively and linguistically (or legal representatives in case of permanent incapacity) 4. Older than 18 years 5. Meet the diagnosis of SE or prolonged seizures > 5 minutes Comparison Group 1: Focal Epilepsy with Brief Seizures 1. Adults diagnosed with focal epilepsy and brief seizures 2. Older than 18 years 3. Diagnosis of focal seizures or epilepsy according to the proposed definition by the ILAE Comparison Group 2: Patients Admitted to ICU Without Seizures 1. Adults admitted to the ICU 2. Older than 18 years Healthy Comparison Group: Healthy Volunteers 1. Adults older than 18 years
Exclusion criteria
Exclusion criteria: Patients with SE 1. Inability to undergo MRI scanning (e.g., MRI incompatible implanted devices, agitation, etc.) 2. Patients who did not give consent Comparison Group 1: Focal Epilepsy with Brief Seizures 1. History of status epilepticus 2. Inability to undergo MRI scanning (e.g., MRI incompatible implanted devices, agitation, etc.) 3. Patients who did not give consent Comparison Group 2: Patients Admitted to ICU Without Seizures 1. Active status epilepticus 2. Inability to undergo MRI scanning (e.g., MRI incompatible implanted devices, agitation, etc.) 3. Patients who did not give consent Healthy Comparison Group: Healthy Volunteers 1. Active relevant neurological condition or a history of a relevant neurological condition (particularly those with seizures, a neurodegenerative condition, or brain lesions) 2. Patients who did not give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Brain Morphology Changes (MRI): Evaluate brain atrophy in patients with status epilepticus (SE) using structural MRI scans performed at baseline (during or shortly after SE), at hospital discharge, and at a 6-month follow-up 2. Biomarkers of Brain Damage (Blood/CSF): Measure and analyze blood and CSF biomarkers of brain damage, such as neurofilament light chain (NfL), GFAP, tau, and interleukins, to assess the extent of brain injury related to SE | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mechanisms of SE-Related Brain Damage: Investigate the underlying mechanisms of brain damage caused by SE, focusing on neurotransmitter disturbances (e.g., glutamatergic system), inflammation, blood-brain barrier disruption, axonal damage, and neurofibrillary tangle accumulation through advanced MRI sequences and biomarker analysis. 2. Correlation Between SE Characteristics and Brain Damage: Examine how SE characteristics (e.g., duration, type, and etiology) correlate with changes in brain morphology and biomarker levels, identifying areas of the brain most vulnerable to SE-related structural damage. 3. Long-Term Neuropsychological Outcomes: Assess the relationship between brain atrophy and biomarker changes with long-term neuropsychological outcomes, including cognitive performance at the 6-month follow-up. 4. Neuroprotective Effects of Treatments: Evaluate the impact of specific treatments (e.g., ketamine, sodium valproate) on reducing brain atrophy and improving neuropsychological outcomes by correlating treatment types and durations with changes in biomarkers of brain damage and cognitive performance. 5. Predictive Value of Biomarkers and Clinical Variables: Analyze whether biomarkers and clinical data obtained at baseline can predict long-term outcomes of SE, including brain damage and neuropsychological performance. | — |
Countries
Austria, England, Switzerland, United Kingdom