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The Use Of Continuous Electroencephalographic EEG Monitoring For Cases Of Refractory Status Epilepticus Does It Affect The Final Patient Outcome

London
Posted 25 days ago
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Actively Recruiting

Phase Not Applicable

Age: 16 Years +

All Genders

ID04170491

The Use of Continuous Electroencephalographic EEG Monitoring for Cases of Refractory Status Epilepticus Does it Affect the Final Patient Outcome

Led by Barts & The London NHS Trust

Updated on 2026-05-08

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

  • AI-Summary
  • Brief Title
  • Who Can Participate
  • AI-Screening
  • Your Study Journey
  • Trial Site Locations
  • Research Team
  • How is the study designed?
  • Similar Trials
  • Frequently Asked Questions

AI-Summary

What This Trial Is About

Researchers are investigating the use of continuous electroencephalogram (cEEG) monitoring as a diagnostic tool in intensive care units (ICU) for patients with refractory status epilepticus (RSE). This randomized feasibility study aims to determine whether cEEG can reduce hospital stay length, mortality, and complications compared to standard medical care. The study also evaluates quality of life at 0, 3, 6, and 12 months after discharge and collects data to plan a larger future trial.

Participants are randomly assigned to either a control group receiving sequential portable EEGs based on clinical need or a treatment group undergoing continuous EEG monitoring starting within 12 hours of RSE diagnosis. In the treatment group, cEEG continues until 24 hours after seizure activity stops, with daily reactivity testing and frequent review by neurophysiologists. Both groups receive care from the same medical team following standard guidelines.

Throughout the study, researchers collect detailed clinical data including demographics, seizure history, seizure types, treatments used, and ICU and hospital discharge dates. They track complications, mortality, seizure control time, and quality of life using questionnaires at multiple time points. Data on hospital costs and the time required for EEG assessments are also gathered. The primary outcome is ICU stay length, with secondary outcomes including health status and hospital charges, monitored up to three years after recruitment.

CONDITIONS

Brief Title

EEG Monitoring for Refractory Status Epilepticus

Who Can Participate

Age: 16 Years +

All Genders

Eligibility Criteria

You may qualify if you...

  • Patients aged > 16 years
  • Consent obtained according to Mental Capacity Act 2005
  • Patients admitted to ICU for treatment of status epilepticus or diagnosed with status epilepticus during admission
  • Convulsive status epilepticus lasting longer than 5 minutes, focal status epilepticus with impaired consciousness lasting longer than 10 minutes, or non-convulsive status epilepticus as defined by Salzburg consensus criteria
  • Status epilepticus continuing despite treatment with benzodiazepine and one antiepileptic medication

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AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

  1. First name *
  2. Last name *
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Your Study Journey

Screening

  • Duration: 2 to 4 weeks
  • Participants are screened for eligibility to participate in the trial.
  • 1 visit (in-person)

Treatment

  • Duration: Up to several days during ICU stay until seizure cessation
  • Participants receive EEG monitoring as part of their care for refractory status epilepticus. The control group receives sequential portable EEGs performed based on clinical need, usually 2 recordings of 20-30 minutes each within 24 to 48 hours. The treatment group receives continuous EEG monitoring starting within 12 hours of diagnosis and continuing until 24 hours after seizure activity stops, with daily reactivity testing and twice daily EEG interpretation.
  • Continuous monitoring for treatment group; 2 EEG recordings for control group during hospital stay

Follow-up

  • Duration: 12 months post-discharge
  • Participants are followed up after discharge to assess quality of life and health status using questionnaires at 0, 3, 6, and 12 months post-discharge, with some data collected by mail or telephone interviews.
  • 4 follow-up assessments via mail or telephone

Trial Site Locations

Total: 1 location

Royal London Hospital

London, United Kingdom, E1 1FR

Actively Recruiting

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Leaflet

Research Team

  • Vasiliki Tsirka, Consultant

How is the study designed?

  • Study Type: INTERVENTIONAL
  • Masking: NONE
  • Allocation: RANDOMIZED
  • Model: PARALLEL
  • Primary Purpose: Other
  • Number of Arms: 2

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  • **Patient-

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Skills

Electroencephalogram (EEG) Monitoring
Clinical Data Collection
Patient Screening
Neurophysiology
ICU Protocols
Data Analysis

Location

London, England, United Kingdom

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