Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-26 @ 6:04 AM
Study NCT ID:
NCT03742661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-07-10
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 New Diagnosis
Sponsor:
Brain Sentinel
Organization:
Study Overview
Official Title:
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2019-07
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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.
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?: