The STatus Epilepticus Prognosis Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

patients not meeting inclusion criteria

acute brain injury or brain tumour as immediate cause of status epilepticus

Trial population

Overall, 50 status epilepticus patients will be identified in three ICUs in London, Ontario over three years. Study participants will be SE patients admitted to either the medical-surgical intensive care unit (MSICU), the cardiac surgery recovery unit (CSRU) or the critical care trauma centre (CCTC) at London Health Sciences Centre. Up to 50 people with epilepsy will also be recruited from the Neurology outpatient clinic and Epilepsy Monitoring Unit at University Hospital to serve as patient controls for the neurocognitive testing component of this study. The investigators expect up to 12 Refractory Status Patients to be recruited for objective 3 and an equivalent number of healthy controls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

serum extracellular microvesicle analysis

analysis of blood samples to assess for markers of neuronal injury

Time frame
Day 1-21 after admission
2

Creyos cognitive battery

Longitudinal online cognitive assessment

Time frame
1-12 months after admission
3

functional MRI

Longitudinal assessment in patients with refractory status epilepticus

Time frame
3-6 months after admission

Secondary outcomes

1

Function outcome

modified Rankin Scale - Scores from 0-6 with lower scores indicating a better outcome (0=no symptoms; 6=death)

Time frame
1-12 months after admission
2

Function outcome

Telephone Interview for Cognitive Status - maximum 41 points, minimum 0 points, higher scores indicate better outcome

Time frame
1-12 months after admission
3

Function outcome

Neuro-Quality of Life - Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment; Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment; Scores 2.0 SD or more worse than the mean = severe symptoms/impairment

Time frame
1-12 months after admission

Other outcomes

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