Improving prognosis for patients with Status Epilepticus
The STatus Epilepticus Prognosis Study
This study is trying to find blood markers that can help predict how well patients with Status Epilepticus will recover in the ICU and how their thinking skills may change after they leave the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06590883 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the prognosis of patients experiencing Status Epilepticus (SE) by identifying biomarkers that predict outcomes during their ICU stay. Researchers will analyze blood samples for brain protein micro-particles to determine their correlation with patient recovery. Additionally, the study will assess long-term cognitive outcomes in SE survivors using the Creyos cognitive testing platform, which evaluates various cognitive functions over a year. The study addresses the current lack of reliable prognostic information for SE patients and seeks to clarify the cognitive impairments that may arise post-ICU discharge.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 who develop Status Epilepticus while in the ICU and have no significant pre-existing neurological conditions.
Not a fit: Patients with a history of severe neurological conditions such as dementia or those with devastating neurological injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into predicting recovery outcomes for patients with Status Epilepticus, leading to improved patient management.
How similar studies have performed: While the approach of using biomarkers for prognosis in SE is gaining attention, this specific study's methodology and focus on long-term cognitive outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 80 years of age * SE requiring admission to critical care * Developed SE while in ICU * No history of a neurologic condition, other than epilepsy, that would impact cognition (Dementia, Parkinson's disease, Alzheimer's disease) * Absence of devastating neurologic injury (cardiac arrest, stroke, traumatic brain injury) In addition, for non-SE epilepsy controls for Creyos task: * People with epilepsy * No history of status epilepticus * Patient has not stereotaxic EEG monitoring * English speaking * No history of a neurologic condition, other than epilepsy, that would impact cognition (Dementia, Parkinson's disease, Alzheimer's disease) In addition, for follow up MRI purposes only: * Diagnosed with refractory status epilepticus while in ICU * No MRI contraindications (metal in body, pacemakers, etc.) Inclusion Criteria Healthy Control Population for MRI imaging: * No history of a neurologic condition that would impact cognition (Dementia, Parkinson's disease, Alzheimer's disease) * No MRI contraindications (metal in body, pacemakers, etc.) Exclusion Criteria: * patients not meeting inclusion criteria * acute brain injury or brain tumour as immediate cause of status epilepticus
Where this trial is running
London, Ontario
- Lawson Health Research Institute — London, Ontario, Canada (Recruiting)
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.