Formative Validation of the MoveChecker System

Gaia AG

Status: Completed

Conditions: Epilepsy

Treatments: Other: collect movement data from epileptic seizures

Study type: Observational

Funder types: Industry

Identifiers

NCT05824611

MoveChecker Form. Validation

Details and patient eligibility

About

obtain motion sequences of at least 60 epileptic seizures

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 1 patient group

participants

Description:

patients with epilepsy included in the study at one of the study locations

Treatment:

Other: collect movement data from epileptic seizures