Putting Electroencephalography (EEG) in the Emergency Department

NCT01355211 | Completed DMC

• 1 other identifier: RC3NS070658
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Altered Mental Status; Generalized Nonconvulsive Seizure Disorder; Status-epilepticus

Keywords

Altered Mental Status; non-convulsive seizure; status epilepticus; electroencephalography

Outcome Measures

Primary Outcomes (1)

• Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS)

  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 EEG recordings

  6 months

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bio-Signal Group Corp.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• State University of New York - Downstate Medical Center: collaborator
• Kings County Hospital Department of Emergency Medicine: collaborator

Study Sites (1)

450 Clarkson Avenue

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• 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.

  PMID: 24070982 DERIVED

MeSH Terms

Conditions

Epilepsy, Generalized; Status Epilepticus

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahriar Zehtabchi, MD

  Recruiting

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 2, 2012

Record last verified: 2012-02

Locations

US (1)