Clinical trial NCT01355211: Putting Electroencephalography (EEG) in the Emergency Department
Official title: Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Altered Mental Status
Generalized Nonconvulsive Seizure Disorder
Status-epilepticus
Keywords: Altered Mental Status
non-convulsive seizure
status epilepticus
electroencephalography
Lead sponsor: Bio-Signal Group Corp.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: State University of New York - Downstate Medical Center
name: Kings County Hospital Department of Emergency Medicine
First posted: 2011-05-18
Enrollment: 261
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 260 patients will be recruited for the study. Adult and pediatric patients ≥ 13 year-old with AMS on arrival to ED

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

ED patients ≥ 13 year-old with AMS on arrival to ED

Exclusion Criteria:

1. Patients with apparent and immediately correctable cause of AMS upon presentation (determined by ED attending physician during initial evaluation):

   * Patients with finger stick or serum glucose less than 60 mg/dl
   * Patients with hypothermia
   * Patients with hyperthermia, heat exhaustion or heat stroke
   * Patients with opioid overdose responding to Narcan
2. Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
3. Hemodynamically unstable patients (SBP \< 90 mmHg)
4. Uncooperative or combative patients on whom the EEG simply cannot be obtained.

Primary outcomes:
measure: Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: 450 Clarkson Avenue
state: New York
Study officials:
affiliation: Recruiting
name: Shahriar Zehtabchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Malhotra S, Weedon J, Fenton AA, Grant AC. Prevalence of non-convulsive seizure and other electroencephalographic abnormalities in ED patients with altered mental status. Am J Emerg Med. 2013 Nov;31(11):1578-82. doi: 10.1016/j.ajem.2013.08.002. Epub 2013 Sep 23.