EEG Monitoring for Refractory Status Epilepticus

NCT04170491 | Recruiting

• 1 other identifier: 240176
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Length of ICU stay

  The length of ICU stay will be measured as the primary outcome measure. This will be compared between the two groups.

  18 months from recruitment onset (anticipated)

Secondary Outcomes (3)

• Health status evaluation

  End of the study- 3 years

• Mortality

  18 months from recruitment onset

• Hospital charges

  End of the study- 3 years

Study Arms (2)

control

NO INTERVENTION

The standard medical care (Control) group will receive sequential portable EEGs, performed according to clinical demand. These patients usually have 2 recordings of 20-30 minutes each within 24 or 48 hours. The studies include baseline recoding and recording after auditory, tactile and nociceptive stimulation. The EEGs will be visually reviewed and reported within 4 hours after the recording completion by a Consultant Clinical Neurophysiologist or other doctor with equivalent qualifications.

cEEG

EXPERIMENTAL

The treatment (cEEG) group will have cEEG applied within 12 hours of RSE diagnosis, which will continue until 24 hours after cessation of clinical and electrical seizure activity. Reactivity testing with auditory, tactile and nociceptive stimulation will be repeated at least once daily. The cEEG will be visually interpreted twice daily by a Consultant Clinical Neurophysiologist and the results will be communicated within two hours of their completion to the treating clinical team.

Diagnostic Test: Continuous EEG

Interventions

Continuous EEG DIAGNOSTIC_TEST

Continuous EEGs will be performed with 21 electrodes and polygraphy (ECG and EMG) placed according to the international 10-20 system. In case of extensive neurosurgical defects, a reduced montage may be applied in patients from either group. This information will be added in CRF. The reduced montage in these cases is not expected to reduce the diagnostic accuracy and the outcome, as the neurophysiological changes are generally diffuse and will be detected by adjacent electrodes.

cEEG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 SE during their admission
• Convulsive Status epilepticus defined by either:
• Tonic-clonic SE lasting longer than 5 minutes,
• Focal SE with impaired consciousness lasting longer than 10 minutes
• or Non-Convulsive SE according to Salzburg consensus criteria
• Status epilepticus that continues despite treatment with benzodiazepine and one antiepileptic medication

You may not qualify if:

• Anoxic brain injury

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Royal London Hospital

London, E1 1FR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Vasiliki Tsirka, Consutlant

CONTACT

00447407781374; vasiliki.tsirka@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 20, 2019
• Study Start: March 17, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)