NCT05824611

Formative Validation of the MoveChecker System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	collect movement data from epileptic seizures	non-invasive recording of movement data during care as usual

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-04-21
• Last updated: 2024-02-09

Locations

4 sites across 1 country: Germany