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Formative Validation of the MoveChecker System

Sponsor
Gaia AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05824611
Collaborator
(none)
105
Enrollment
5
Locations
10.1
Anticipated Duration (Months)
21
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

obtain motion sequences of at least 60 epileptic seizures

Condition or Disease Intervention/Treatment Phase
  • Other: collect movement data from 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 Design

Study Type:
Observational
Anticipated Enrollment :
105 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Formative Validation of the MoveChecker System
Actual Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
participants

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. qualitative assessment of the clinical benefit of the system [through study completion]

      Semi-standardised interviews with clinical staff and patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsmedizin Greifswald Greifswald Mecklenburg-Vorpommern Germany 17475
    2 Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld Bielefeld North Rhine-Westphalia Germany 33617
    3 Universitätsklinikum Bonn Bonn North Rhine-Westphalia Germany 53113
    4 Epilepsiezentrum Kleinwachau Radeberg Saxony Germany 01454
    5 Evangelisches Krankenhaus Königin Elisabeth Herzberge Berlin Germany 10365

    Sponsors and Collaborators

    • Gaia AG

    Investigators

    • Principal Investigator: Michael Domhardt, Dr.-Ing., GAIA AG (Sponsor)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gaia AG
    ClinicalTrials.gov Identifier:
    NCT05824611
    Other Study ID Numbers:
    • MoveChecker Form. Validation
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 25, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Apr 25, 2023