Clinical trial NCT05824611: Formative Validation of the MoveChecker System
Official title: Formative Validation of the MoveChecker System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are included in special care clinics (epilepsy monitoring units), study inclusion is confirmed by a physician at the clinic

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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* diagnosis of epilepsy (ICD code G40.x)

Exclusion Criteria:

* suspected epilepsy (no diagnosis)
* 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

Primary outcomes:
measure: motion sequences of at least 60 epileptic seizures
timeFrame: up to 4 days
Secondary outcomes:
measure: qualitative assessment of the clinical benefit of the system
timeFrame: through study completion
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
state: Mecklenburg-Vorpommern
city: Bielefeld
country: Germany
facility: Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld
state: North Rhine-Westphalia
city: Radeberg
country: Germany
facility: Epilepsiezentrum Kleinwachau
state: Saxony
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Königin Elisabeth Herzberge
Study officials:
affiliation: GAIA AG (Sponsor)
name: Michael Domhardt, Dr.-Ing.
role: PRINCIPAL_INVESTIGATOR
References: