Putting Electroencephalography (EEG) in the Emergency Department

Completed

Conditions studied: Altered Mental Status, Generalized Nonconvulsive Seizure Disorder, Status-epilepticus

In brief

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.

Key facts

Study ID

NCT01355211

Run by

Bio-Signal Group Corp.

People needed

261

Starts

2011-04-01

Expected to finish

2012-02-01

Last updated by the study team

2012-03-02

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 450 Clarkson Avenue — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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