Monitoring brain activity in patients with severe seizures
The Use of Continuous Electroencephalographic (EEG) Monitoring for Cases of Refractory Status Epilepticus: Does it Affect the Final Patient Outcome
This study is testing if continuous brain monitoring can help improve recovery and outcomes for patients with severe seizures in the ICU compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04170491 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuous electroencephalogram (cEEG) monitoring in patients with refractory status epilepticus (RSE) in an intensive care unit setting. Patients will be randomly assigned to receive either standard medical care or cEEG monitoring, which will continue for 24 hours after seizure activity ceases. The study aims to assess whether cEEG can improve patient outcomes, including reduced hospital stay, lower mortality rates, and enhanced quality of life post-discharge. Data will be collected from patient medical records to evaluate the impact of cEEG on clinical outcomes compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are patients over 16 years old diagnosed with refractory status epilepticus who have not responded to initial treatments.
Not a fit: Patients with anoxic brain injury will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients suffering from refractory status epilepticus.
How similar studies have performed: There is currently no available data from previous studies assessing the impact of continuous EEG on clinical outcomes in patients with refractory status epilepticus, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • 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
Exclusion Criteria:
* Anoxic brain injury
Where this trial is running
London
- Royal London Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Vasiliki Tsirka, Consutlant
- Email: vasiliki.tsirka@nhs.net
- Phone: 00447407781374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.