Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2023-02-27
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
OTHER
Study Groups
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participants
patients with epilepsy included in the study at one of the study locations
collect movement data from epileptic seizures
non-invasive recording of movement data during care as usual
Interventions
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collect movement data from epileptic seizures
non-invasive recording of movement data during care as usual
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis of epilepsy (ICD code G40.x)
Exclusion Criteria
* comorbidities affecting the motor system
* dermatosis in an area of the body relevant to the sensor attachment
* contact allergy due to plaster or sensor material
* known or current illness or disorder that interferes with the ability to understand study participation requirements or to provide informed consent
18 Years
ALL
No
Sponsors
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Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Domhardt, Dr.-Ing.
Role: PRINCIPAL_INVESTIGATOR
GAIA AG (Sponsor)
Locations
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Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld
Bielefeld, North Rhine-Westphalia, Germany
Epilepsiezentrum Kleinwachau
Radeberg, Saxony, Germany
Evangelisches Krankenhaus Königin Elisabeth Herzberge
Berlin, , Germany
Countries
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Other Identifiers
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MoveChecker Form. Validation
Identifier Type: -
Identifier Source: org_study_id
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