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obtain motion sequences of at least 60 epileptic seizures
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants | patients with epilepsy included in the study at one of the study locations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collect movement data from epileptic seizures | Other | non-invasive recording of movement data during care as usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| motion sequences of at least 60 epileptic seizures | Motion sequences of at least 60 epileptic seizures, that include the spatial orientation of the nine sensors attached to the participant sampled and recorded at a rate of 30Hz continuously | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| qualitative assessment of the clinical benefit of the system | Semi-standardised interviews with clinical staff and patients | through study completion |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are included in special care clinics (epilepsy monitoring units), study inclusion is confirmed by a physician at the clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michael Domhardt, Dr.-Ing. | GAIA AG (Sponsor) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Greifswald | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany | ||
| Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 20, 2024 | |
| Reset | Aug 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 20, 2024 | Aug 16, 2024 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Bielefeld |
| North Rhine-Westphalia |
| 33617 |
| Germany |
| Epilepsiezentrum Kleinwachau | Radeberg | Saxony | 01454 | Germany |
| Evangelisches Krankenhaus Königin Elisabeth Herzberge | Berlin | 10365 | Germany |