Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824611
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2023-03-17
Brief Title:
Formative Validation of the MoveChecker System
Sponsor:
Gaia AG
Organization:
Gaia AG
Study Overview
Official Title:
Formative Validation of the MoveChecker System
Status:
COMPLETED
Status Verified Date:
2024-02
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:
obtain motion sequences of at least 60 epileptic seizures
Detailed Description:
Extensive movement data are required to develop an automatic pattern recognition that makes it possible to distinguish movements of epileptic seizures from everyday activities The aim of collecting formative validation data for the system is to collect movement data from as many epileptic seizures as possible to develop such pattern recognition in the future
A system is being investigated that uses several non-invasive sensors attached to the extremities and trunk of the test subjects with plasters to record abnormal movement patterns and play them back to detect epileptic seizures with motor involvement In the study registered here the movement data of at least 60 epileptic seizures with motor components will be recorded parallel to routine diagnostics using video EEG or video monitoring
The primary goal is to collect formative validation data for the system This includes recording the movements of at least 60 epileptic seizures per sample during the hospital stay of the participants to develop future pattern recognition for the system The secondary goals include the qualitative assessment of the clinical benefit of the system from the point of view of the patient and the medical staff
A system is being investigated that uses several non-invasive sensors attached to the extremities and trunk of the test subjects with plasters to record abnormal movement patterns and play them back to detect epileptic seizures with motor involvement In the study registered here the movement data of at least 60 epileptic seizures with motor components will be recorded parallel to routine diagnostics using video EEG or video monitoring
The primary goal is to collect formative validation data for the system This includes recording the movements of at least 60 epileptic seizures per sample during the hospital stay of the participants to develop future pattern recognition for the system The secondary goals include the qualitative assessment of the clinical benefit of the system from the point of view of the patient and the medical staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None