Formative Validation of the MoveChecker System

Completed

• Conditions: Epilepsy
• Interventions: Other: collect movement data from epileptic seizures

• Registration Number: NCT05824611
• Lead Sponsor: Gaia AG

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.

Study Timeline

• Study Start: 2023-02-27
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participants	collect movement data from epileptic seizures	patients with epilepsy included in the study at one of the study locations

Primary Outcome Measures

Name	Time	Method
motion sequences of at least 60 epileptic seizures	up to 4 days	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

Secondary Outcome Measures

Name	Time	Method
qualitative assessment of the clinical benefit of the system	through study completion	Semi-standardised interviews with clinical staff and patients

Trial Locations

Locations (4)

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany

Epilepsiezentrum Kleinwachau; 🇩🇪 Radeberg, Saxony, Germany

Evangelisches Krankenhaus Königin Elisabeth Herzberge; 🇩🇪 Berlin, Germany

Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld; 🇩🇪 Bielefeld, North Rhine-Westphalia, Germany