Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-28 @ 9:33 AM
Study NCT ID:
NCT01202669
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2010-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Changes in Subjects With Epilepsy
Sponsor:
Cyberonics, Inc.
Organization:
Study Overview
Official Title:
Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission
Status:
COMPLETED
Status Verified Date:
2014-08
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 purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.
Detailed Description:
Observational, unblinded, non-randomized, multisite study designed to collect data on up to 500 subjects undergoing evaluation for epilepsy in EMUs. Subjects currently enrolled or that previously participated in this study may be eligible for the E-30-S sub-study.
Study Oversight
Has Oversight DMC:
False
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?: