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Formative Validation of the MoveChecker System

Formative Validation of the MoveChecker System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05824611
Enrollment
53
Registered
2023-04-21
Start date
2023-02-27
Completion date
2023-12-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

OTHERcollect movement data from epileptic seizures

non-invasive recording of movement data during care as usual

Sponsors

Gaia AG
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
motion sequences of at least 60 epileptic seizuresup to 4 daysMotion 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

MeasureTime frameDescription
qualitative assessment of the clinical benefit of the systemthrough study completionSemi-standardised interviews with clinical staff and patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026