Status EpilepticusNCT04170491
EEG Monitoring for Refractory Status Epilepticus
A study testing Continuous EEG in people with Status Epilepticus, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Continuous EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2020to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- Anoxic brain injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, E1 1FR
Vasiliki Tsirka, Consutlant, 00447407781374, vasiliki.tsirka@nhs.net
About this study
Official title: The Use of Continuous Electroencephalographic (EEG) Monitoring for Cases of Refractory Status Epilepticus: Does it Affect the Final Patient Outcome
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
Read the detailed description
The study is a randomised feasibility study.
The patients participating in the study will be randomised 1:1 in two groups. The randomisation will be stratified by three status epilepticus (SE) aetiologies a) previous epilepsy b) acute central nervous system insult c) cryptogenic/ unknown.
The standard medical care group (Control group) will receive sequential portable electroencephalograms (EEGs), performed according to the clinical demand. The treatment group (cEEG group) will have cEEG, which will continue until 24 hours after cessation of clinical and electrical seizure activity. The patients will be treated by the same medical team of neurologists or neurointensivists, according to the same guidelines.
Clinical data will be collected from observation of in-patient medical records. The information will include demographics i.e. age, gender and ethnicity group, information about previous medical history and specifically previous history of epilepsy. The investigators will record the type of epilepsy, the type of previous seizures, their frequency, previous admissions due to SE and current and previously used antiepileptic drugs. These data can be obtained either by the patient or the next of kin and if the patient is followed up in the local epilepsy service, the required data may be obtained from the medical records.
Regarding the acute presentation of status epilepticus, data will be collected regarding the date and the time of diagnosis of SE, the date of seizure onset, the level of consciousness on presentation, the type of seizures during SE (i.e. focal motor, generalised motor, absence etc) and SE aetiology, if available. If the SE is diagnosed by EEG as non-convulsive, the date of the diagnosis will be recorded. The types of seizures during the course of SE will be recorded, as well as the antiepileptic drugs and sedation used, including the doses. The SE severity score (STESS) will be calculated early during the patient admission to ICU. The date that the patient was fit for discharge from ICU will be obtained, as well as the date of discharge from hospital. It is noted that the date the patient is fit for discharge from ICU is not always the same as the actual date of ICU discharge. The data will also include in-hospital and 30-days mortality, the time until seizure control and the reported hospital acquired complications and specifically healthcare-associated infections, pressure injuries, falls resulting in fractures or injuries, respiratory complications, venous thromboembolism and medication complications. The quality of life index will be assessed with the health questionnaire introduced by EuroQol Group (version EQ-5D-5L), at 0, 3 ,6 and 12 months post discharge and/ or the Quality of Life in Epilepsy questionnaire (QOLIE), which will be mailed to the patients. If the patient is not able to provide this information in writing, these data will be collected with brief telephone interview.
The observational data will be collected by the research nurse and will be transferred to the case report form (CRF). The specific information, regarding the seizure types and the seizure aetiology, will require input from the medical team and specifically the neurologist, the neurointensivist and the clinical neurophysiologist. The information gather will be reviewed and supervised by the Principal Investigator (PI).
The data regarding the hospital costs for each patient will be collected after the patient's discharge and will be based on the specific coding of all medical, diagnostic and therapeutic interventions registered for each patient, taking into account the additional time required for assessing cEEG data. The clinical neurophysiologist and the physiologist will log their clinical activity time required for reviewing the cEEG recordings.
The data will be transferred to CRF and the length of ICU and in-hospital stay and the quality of life measures will be compared between groups in order to identify differences in the final outcome between the control and the cEEG groups. Similarly, the costs for management of the two patient groups will be compared.
The calculation of the sample size for the larger study will be performed after the collection of 40 cases.
- Conditions
- Status Epilepticus
- Being tested
- Continuous EEG
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous EEGDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Continuous EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months from recruitment onset (anticipated)
Secondary outcomes (3)
Health status evaluation
Assessed with EQ-5D-5L scale. Maximum value 1 indicates reported full health state. Minimum value -0.594.
Measured: End of the study- 3 years
Mortality
In-hospital and/or 30-days mortality
Measured: 18 months from recruitment onset
Hospital charges
The hospital charges (in British pounds) will be compared between the two groups.
Measured: End of the study- 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Mar 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170491
- Sponsor's protocol ID
- 240176
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2019
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Electroencephalographic (EEG) Monitoring for Cases of Refractory Status Epilepticus: Does it Affect the Final Patient Outcome
- ClinicalTrials.gov ID
- NCT04170491
- Acronym / sponsor ID
- 240176
- Conditions
- Status Epilepticus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study is a randomised feasibility study.
The patients participating in the study will be randomised 1:1 in two groups. The randomisation will be stratified by three status epilepticus (SE) aetiologies a) previous epilepsy b) acute central nervous system insult c) cryptogenic/ unknown.
The standard medical care group (Control group) will receive sequential portable electroencephalograms (EEGs), performed according to the clinical demand. The treatment group (cEEG group) will have cEEG, which will continue until 24 hours after cessation of clinical and electrical seizure activity. The patients will be treated by the same medical team of neurologists or neurointensivists, according to the same guidelines.
Clinical data will be collected from observation of in-patient medical records. The information will include demographics i.e. age, gender and ethnicity group, information about previous medical history and specifically previous history of epilepsy. The investigators will record the type of epilepsy, the type of previous seizures, their frequency, previous admissions due to SE and current and previously used antiepileptic drugs. These data can be obtained either by the patient or the next of kin and if the patient is followed up in the local epilepsy service, the required data may be obtained from the medical records.
Regarding the acute presentation of status epilepticus, data will be collected regarding the date and the time of diagnosis of SE, the date of seizure onset, the level of consciousness on presentation, the type of seizures during SE (i.e. focal motor, generalised motor, absence etc) and SE aetiology, if available. If the SE is diagnosed by EEG as non-convulsive, the date of the diagnosis will be recorded. The types of seizures during the course of SE will be recorded, as well as the antiepileptic drugs and sedation used, including the doses. The SE severity score (STESS) will be calculated early during the patient admission to ICU. The date that the patient was fit for discharge from ICU will be obtained, as well as the date of discharge from hospital. It is noted that the date the patient is fit for discharge from ICU is not always the same as the actual date of ICU discharge. The data will also include in-hospital and 30-days mortality, the time until seizure control and the reported hospital acquired complications and specifically healthcare-associated infections, pressure injuries, falls resulting in fractures or injuries, respiratory complications, venous thromboembolism and medication complications. The quality of life index will be assessed with the health questionnaire introduced by EuroQol Group (version EQ-5D-5L), at 0, 3 ,6 and 12 months post discharge and/ or the Quality of Life in Epilepsy questionnaire (QOLIE), which will be mailed to the patients. If the patient is not able to provide this information in writing, these data will be collected with brief telephone interview.
The observational data will be collected by the research nurse and will be transferred to the case report form (CRF). The specific information, regarding the seizure types and the seizure aetiology, will require input from the medical team and specifically the neurologist, the neurointensivist and the clinical neurophysiologist. The information gather will be reviewed and supervised by the Principal Investigator (PI).
The data regarding the hospital costs for each patient will be collected after the patient's discharge and will be based on the specific coding of all medical, diagnostic and therapeutic interventions registered for each patient, taking into account the additional time required for assessing cEEG data. The clinical neurophysiologist and the physiologist will log their clinical activity time required for reviewing the cEEG recordings.
The data will be transferred to CRF and the length of ICU and in-hospital stay and the quality of life measures will be compared between groups in order to identify differences in the final outcome between the control and the cEEG groups. Similarly, the costs for management of the two patient groups will be compared.
The calculation of the sample size for the larger study will be performed after the collection of 40 cases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Continuous EEGThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- • Patients aged > 16 years
Key exclusion criteria (1 listed)
- Anoxic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous EEGContinuous 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. | Diagnostic test | cEEG |
Primary outcome
Length of ICU stay
Time frame: 18 months from recruitment onset (anticipated)
The length of ICU stay will be measured as the primary outcome measure. This will be compared between the two groups.
3 secondary outcomes
Health status evaluation
Time frame: End of the study- 3 years
Mortality
Time frame: 18 months from recruitment onset
Hospital charges
Time frame: End of the study- 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous EEG in people with Status Epilepticus, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasiliki Tsirka, Consutlant (00447407781374, vasiliki.tsirka@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU stay (time frame: 18 months from recruitment onset (anticipated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.