Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01355211
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2011-05-16
Brief Title:
Putting Electroencephalography EEG in the Emergency Department
Sponsor:
Bio-Signal Group Corp
Organization:
Bio-Signal Group Corp
Study Overview
Official Title:
Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 statusThe 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
This study will also provide valid information regarding the prevalence of non-convulsive seizure in ED patients with altered mental statusThe 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 positivenegative 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 eg confusion lethargy delirium coma aphasia disinhibition labileblunted 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 NCZA seizure without clonic or tonic activity or other convulsive motor activity
Status Epilepticus SESE 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
Population ED patients with altered mental status AMS Intervention Micro-EEG Comparison Standard EEG Outcomes 1 Sensitivity specificity positivenegative 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 eg confusion lethargy delirium coma aphasia disinhibition labileblunted 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 NCZA seizure without clonic or tonic activity or other convulsive motor activity
Status Epilepticus SESE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RC3NS070658 | NIH | None | httpsreporternihgovquickSearchRC3NS070658 |