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Completed

NCT Number: NCT05824611

Formative Validation of the MoveChecker System

obtain motion sequences of at least 60 epileptic seizures

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsmedizin Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collect movement data from epileptic seizures

Other

non-invasive recording of movement data during care as usual

Other names: MoveChecker

Primary outcomes

  1. motion sequences of at least 60 epileptic seizures

    Time frame: 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 outcomes

  1. qualitative assessment of the clinical benefit of the system

    Time frame: through study completion

    Semi-standardised interviews with clinical staff and patients

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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