Formative Validation of the MoveChecker System

Epilepsy Clinical Trial

Official title:

Formative Validation of the MoveChecker System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824611
• Other study ID #: MoveChecker Form. Validation
• Status: Completed
• Start date: February 27, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

obtain motion sequences of at least 60 epileptic seizures

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• collect movement data from epileptic seizures
non-invasive recording of movement data during care as usual

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Königin Elisabeth Herzberge	Berlin
Germany	Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld	Bielefeld	North Rhine-Westphalia
Germany	Universitätsmedizin Greifswald	Greifswald	Mecklenburg-Vorpommern
Germany	Epilepsiezentrum Kleinwachau	Radeberg	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Gaia AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	qualitative assessment of the clinical benefit of the system	Semi-standardised interviews with clinical staff and patients	through study completion