Clinical Trial

EEG Monitoring for Refractory Status Epilepticus

Recruiting
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Record status
This record was last updated May 8, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-11-18; most recent amendment 2026-05-05.
Status change: Suspended → Recruiting 2025-05-02
Status change: Recruiting → Suspended 2022-10-14
Status change: Not Yet Recruiting → Recruiting 2021-07-19
Trial Details
NCT Number NCT04170491
Lead Sponsor Barts & The London NHS Trust
Conditions Status Epilepticus
Enrollment 40 participants
Start Date 2020-03-17
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-08