Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT04170491

EEG Monitoring for Refractory Status Epilepticus

Led by Barts & The London NHS Trust · Updated on 2026-05-08

40

Participants Needed

1

Research Sites

384 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective randomized study to investigate the yield of continuous electroencephalogram (cEEG), as a diagnostic tool in intensive care unit (ICU), for patients with refractory status epilepticus (RSE) and the contribution of this test to the patient final outcome, compared with standard medical care. Specifically, the hypothesis is that the use of cEEG for patients with RSE will significantly reduce the length of in-hospital stay, mortality, and subsequent complications (such as infections or pressure ulcers). It is also predicted that quality of life will be higher following cEEG at 0, 3, 6 and 12 months after discharge. As there are currently no data available from previous studies assessing the impact of cEEG on markers of the final clinical outcome in patients with RSE, this study is going to start as a feasibility study, aiming to obtain initial data for the primary outcome measure, in order to perform a sample size calculation for a larger future trial. The pilot study will also assess the integrity of the study protocol, specifically the recruitment process and the consent procedure, and also determine the necessary costs for running a cEEG service in ICU for patients with RSE

CONDITIONS

Official Title

EEG Monitoring for Refractory Status Epilepticus

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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 admitted for another reason and diagnosed with status epilepticus during their admission
  • Convulsive status epilepticus defined by either tonic-clonic seizures lasting longer than 5 minutes, focal seizures with impaired consciousness lasting longer than 10 minutes, or non-convulsive status epilepticus as per Salzburg consensus criteria
  • Status epilepticus that continues despite treatment with benzodiazepine and one antiepileptic medication
Not Eligible

You will not qualify if you...

  • Anoxic brain injury

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal London Hospital

London, United Kingdom, E1 1FR

Actively Recruiting

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Research Team

V

Vasiliki Tsirka, Consutlant

CONTACT

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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