Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-03 @ 11:26 PM
Study NCT ID:
NCT03169751
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
Sponsor:
Brain Sentinel
Organization:
Study Overview
Official Title:
An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: