N/A
N=20
EEG Cap for Identification of Non-Convulsive Status Epilepticus
Nonconvulsive Status Epilepticus · Subclinical Seizure · Altered Mental Status · Nonepileptic Seizures · Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT03138876 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Time Difference Between EEG Cap and Standard EEG Results Reporting — 103.4 minutes — p=0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EEG Cap (Device); Anti-seizure medication (Drug); Standard EEG (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Difference Between EEG Cap and Standard EEG Results Reporting |
103.4 | 0.0005 sig |
| SECONDARY Percentage of Participants Whose EEG Cap Recordings Were Interpretable |
14 | — |
| SECONDARY Number of Subjects Diagnosed With NCSE |
3 | — |
| SECONDARY Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE |
3 | — |
Summary
Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.
Eligibility Criteria
Inclusion criteria
- Patients with suspected NCSE in the Mayo Clinic Florida hospital, emergency room or intensive care unit.
- Age: Patients of 18 years or older will be included in this study
- Education: All education levels will be included
Exclusion criteria
- Patients younger than 18 years of age.
- Patients with open head trauma.
- Patients with anatomy that would preclude EEG cap placement.
- Patients excluded for anatomical or age-related reasons will be tracked to determine applicability of the EEG cap to the patient population at Mayo Clinic.
- Pregnant females
- Large head size not amenable to cap placement
- Scalp infection
- Inability to obtain informed consent
Data sourced from ClinicalTrials.gov (NCT03138876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.