| NCT ID | NCT06590883 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Status Epilepticus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-11-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-11-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to improve the prognosis of patients who present with Status Epilepticus (SE). In the first part of this study, the investigators aim to find better markers of good and poor outcomes of SE patients while in the ICU. The objective is to measure the levels of brain protein micro-particles that are detectable in blood samples. The investigators seek to determine whether elevated levels of micro-particles in the bloodstream in SE patients can be used to predict the eventual outcome of survivors. The goal of the second part of the study is to evaluate long-term cognitive outcomes in survivors of SE To date, there is no reliable information to inform what cognitive recovery is like for survivors of SE after ICU discharge. The objective is to use the Creyos cognitive testing platform to assess different domains of cognitive function for up to 1 year after SE onset. Patients who have pre-existing epilepsy but have not had status epilepticus will serve as patient controls for the cognitive testing portion of this study. The third part of this study will evaluate brain changes in survivors of refractory SE. To date, there are no known studies that document to what extent the anatomy of the brain changes following SE. The objective is to characterize these changes by conducting two brain research scans 6 months apart. Patients will be invited to Robart\'s Research Institute for a scan 1-3 months and 6-8 months (6 months apart) after refractory SE to measure structural and functional changes in the brain throughout the recovery process.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06590883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Status Epilepticus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590883 currently recruiting?
Yes, NCT06590883 is actively recruiting participants. Visit ClinicalTrials.gov or contact London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's to inquire about joining.
Where is the NCT06590883 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06590883 clinical trial?
NCT06590883 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 50 participants.