The STatus Epilepticus Prognosis Study

NCT06590883 | Recruiting

• 1 other identifier: REDA12409
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus

Keywords

Neuroimaging; Neuronal injury; cognitive testing

Outcome Measures

Primary Outcomes (3)

• serum extracellular microvesicle analysis

  analysis of blood samples to assess for markers of neuronal injury

  Day 1-21 after admission

• Creyos cognitive battery

  Longitudinal online cognitive assessment

  1-12 months after admission

• functional MRI

  Longitudinal assessment in patients with refractory status epilepticus

  3-6 months after admission

Secondary Outcomes (3)

• Function outcome

  1-12 months after admission

• Function outcome

  1-12 months after admission

• Function outcome

  1-12 months after admission

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.)
• No history of a neurologic condition that would impact cognition (Dementia, Parkinson's disease, Alzheimer's disease)

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens include blood and CSF

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: September 19, 2024
• Study Start: November 27, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (1)