Formative Validation of the MoveChecker System

obtain motion sequences of at least 60 epileptic seizures

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

1

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	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	Semi-standardised interviews with clinical staff and patients	through study completion

Collaborators and Investigators

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

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• 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