Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-25 @ 4:40 PM
Study NCT ID:
NCT03741205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-02-07
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a Recent Non-diagnostic EMU Visit
Sponsor:
Brain Sentinel
Organization:
Study Overview
Official Title:
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a Recent Non-diagnostic EMU Visit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-02
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:
This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, who have had a recent non-diagnostic EMU stay.
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?: