Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-28 @ 10:22 AM
Study NCT ID:
NCT00497835
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2007-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Algorithm for Epilepsy Alert Device
Sponsor:
Biolert
Organization:
Study Overview
Official Title:
Epilepsy Alert Device - Epilert Performance
Status:
COMPLETED
Status Verified Date:
2007-07
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:
An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.
Detailed Description:
Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor will transmit continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed and transformed into an algorithm (up-graded existing preliminary algorithm).
In the second phase the algorithm will need to identify seizure events within one minute of the onset.
Both specificity ("false positive") and sensitivity ("false negative) will be than calculated.
In the second phase the algorithm will need to identify seizure events within one minute of the onset.
Both specificity ("false positive") and sensitivity ("false negative) will be than calculated.
Study Oversight
Has Oversight DMC:
True
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?: