Formative Validation of the MoveChecker System

February 8, 2024 updated by: Gaia AG
obtain motion sequences of at least 60 epileptic seizures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10365
        • Evangelisches Krankenhaus Königin Elisabeth Herzberge
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • Universitätsmedizin Greifswald
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33617
        • Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld
    • Saxony
      • Radeberg, Saxony, Germany, 01454
        • Epilepsiezentrum Kleinwachau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants are included in special care clinics (epilepsy monitoring units), study inclusion is confirmed by a physician at the clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qualitative assessment of the clinical benefit of the system
Time Frame: through study completion
Semi-standardised interviews with clinical staff and patients
through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MoveChecker Form. Validation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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