EEG Cap for Identification of Non-Convulsive Status Epilepticus

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2018-08-16

Brief Summary

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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.

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Detailed Description

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At the completion of neurology evaluation, if NCSE is in the differential diagnosis according to institution best practice, then consented participants will undergo placement of a large size, 20-channel EEG cap from Electro-Cap International with a Natus E-2-2520-26 electrode board adapter with initiation of recording. The placement of the EEG cap will be restricted to residents formally trained in its placement by an EEG tech. This study will only be performed during times when EEG techs are not available onsite for rapid placement of standard 21-channel EEG electrodes, such as during night-call shifts.

Prior to placement of EEG cap, evaluating staff member will request immediate standard-electrode EEG. The investigators will record time from neurology consultation request to placement of EEG cap as well as time from consultation request to obtaining a standard EEG. The investigators will also record time to confirmation or exclusion of NCSE. Initial diagnosis or exclusion of NCSE will be performed by on call resident, if the resident received prior training regarding EEG cap placement, and attending. Secondary quality assessment will be performed by two independent EEG interpreters blinded to clinical history. Secondary assessment will be qualified as acceptable or inacceptable interpretation based on whether greater or less than 50% of the recording is judged interpretable. Secondary assessment will also include interpretation of NCSE by a third independent reader if there is disagreement between first two. The number of patients excluded from the study will also be recorded, including the reason for exclusion.

Conditions

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Nonconvulsive Status Epilepticus Subclinical Seizure Altered Mental Status Nonepileptic Seizures Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects may be treated for NCSE based on EEG cap findings, but only following standard practice. The study is designed to identify NCSE, not to assess treatment of NCSE.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

There will be blinded EEG assessment in terms of the EEG readers.

Study Groups

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EEG Cap

Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

Group Type OTHER

EEG Cap

Intervention Type DEVICE

Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE.

Anti-seizure medication

Intervention Type DRUG

Patients may be treated for NCSE or seizures based on EEG cap findings, if the findings are clear to an attending EEG reviewer. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

Standard EEG

Intervention Type PROCEDURE

An electroencephalogram (EEG) is a test used to find problems related to electrical activity of the brain. An EEG tracks and records brain wave patterns. Small metal discs with thin wires (electrodes) are placed on the scalp, and then send signals to a computer to record the results.

Interventions

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EEG Cap

Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE.

Intervention Type DEVICE

Anti-seizure medication

Patients may be treated for NCSE or seizures based on EEG cap findings, if the findings are clear to an attending EEG reviewer. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

Intervention Type DRUG

Standard EEG

An electroencephalogram (EEG) is a test used to find problems related to electrical activity of the brain. An EEG tracks and records brain wave patterns. Small metal discs with thin wires (electrodes) are placed on the scalp, and then send signals to a computer to record the results.

Intervention Type PROCEDURE

Other Intervention Names

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Electro-Cap

Eligibility Criteria

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Inclusion Criteria

1. Patients with suspected NCSE in the Mayo Clinic Florida hospital, emergency room or intensive care unit.
2. Age: Patients of 18 years or older will be included in this study
3. Education: All education levels will be included

Exclusion Criteria

1. Patients younger than 18 years of age.
2. Patients with open head trauma.
3. Patients with anatomy that would preclude EEG cap placement.
4. 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.
5. Pregnant females
6. Large head size not amenable to cap placement
7. Scalp infection
8. Inability to obtain informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No