Putting Electroencephalography (EEG) in the Emergency Department

This study has been completed.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
Kings County Hospital
Information provided by (Responsible Party):
Bio-Signal Group Corp.
ClinicalTrials.gov Identifier:
NCT01355211
First received: May 16, 2011
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


Condition
Altered Mental Status
Generalized Nonconvulsive Seizure Disorder
Status-epilepticus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status

Resource links provided by NLM:


Further study details as provided by Bio-Signal Group Corp.:

Primary Outcome Measures:
  • Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 261
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01355211

Locations
United States, New York
450 Clarkson Avenue
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
Bio-Signal Group Corp.
State University of New York - Downstate Medical Center
Kings County Hospital
Investigators
Principal Investigator: Shahriar Zehtabchi, MD Recruiting
  More Information

No publications provided by Bio-Signal Group Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bio-Signal Group Corp.
ClinicalTrials.gov Identifier: NCT01355211     History of Changes
Other Study ID Numbers: RC3NS070658, RC3NS070658
Study First Received: May 16, 2011
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bio-Signal Group Corp.:
Altered Mental Status
non-convulsive seizure
status epilepticus
electroencephalography

Additional relevant MeSH terms:
Emergencies
Epilepsy
Epilepsy, Generalized
Seizures
Status Epilepticus
Mental Disorders
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014