Putting Electroencephalography (EEG) in the Emergency Department

Status Completed

Clinical Trial Summary

The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus) in emergency department (ED) patients with altered mental status. Comparing the the accuracy of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the investigators to assess the utility of this novel device in the ED patients with altered mental status. The unique qualities of Micro-EEG device could potentially facilitate easier access to EEG test in all ED patients.

This study will also provide valid information regarding the prevalence of non-convulsive seizure in ED patients with altered mental status.The gold standard for diagnosing non-convulsive seizure would be standard EEG.

All study participants will undergo electroencephalography using the two devices (standard EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG electrodes, and 3. Micro-EEG with Electro-Cap electrodes.

Clinical Trial Description

Formulated Research Question:

Population: ED patients with altered mental status (AMS) Intervention: Micro-EEG Comparison: Standard EEG Outcomes: 1. Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities 2. The concordance of EEG interpretations between micro-EEG and standard EEGs recordings Design Prospective cross-sectional

Definitions:

Altered Mental Status: Any acute change in level of arousability or responsiveness (e.g. confusion, lethargy, delirium, coma, aphasia, disinhibition, labile/blunted affect or unexpected psychosis).

Types of AMS (for the purpose of the study):

1. AMS alone

2. AMS with non-specific motor activity (subtle motor movement such as eye blinking, nystagmus, focal motor movements, or myoclonus)

3. Prolonged AMS following one or more tonic-clonic seizures suggesting status epilepticus Non-convulsive seizure (NCZ):A seizure without clonic or tonic activity or other convulsive motor activity.

Status Epilepticus (SE):SE is defined as 1. More than 30 minutes of continuous seizure activity or 2. Two or more sequential seizures without recovery of consciousness between seizures. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Altered Mental Status
Epilepsy
Epilepsy, Generalized
Generalized Nonconvulsive Seizure Disorder
Mental Disorders
Seizures
Status Epilepticus
Status-epilepticus

Clinical Trial Details

NCT number	NCT01355211
Study type	Observational
Source	Bio-Signal Group Corp.
Contact
Status	Completed
Phase	N/A
Start date	April 2011
Completion date	February 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.