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| ID | Type | Description | Link |
|---|---|---|---|
| RC3NS070658 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| State University of New York - Downstate Medical Center | OTHER |
| Kings County Hospital Department of Emergency Medicine | OTHER |
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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.
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):
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS) |
| 6 months |
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Inclusion Criteria:
ED patients ≥ 13 year-old with AMS on arrival to ED
Exclusion Criteria:
Patients with apparent and immediately correctable cause of AMS upon presentation (determined by ED attending physician during initial evaluation):
Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
Hemodynamically unstable patients (SBP < 90 mmHg)
Uncooperative or combative patients on whom the EEG simply cannot be obtained.
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A total of 260 patients will be recruited for the study. Adult and pediatric patients ≥ 13 year-old with AMS on arrival to ED
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| Name | Affiliation | Role |
|---|---|---|
| Shahriar Zehtabchi, MD | Recruiting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 450 Clarkson Avenue | Brooklyn | New York | 11203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24070982 | Derived | 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. |
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| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D012640 |
| Seizures |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |