NCT05824611

Brief Summary

obtain motion sequences of at least 60 epileptic seizures

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

March 17, 2023

Last Update Submit

February 8, 2024

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • qualitative assessment of the clinical benefit of the system

    through study completion

Study Arms (1)

participants

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

Other: collect movement data from epileptic seizures

Interventions

collect movement data from epileptic seizuresOTHER

non-invasive recording of movement data during care as usual

Also known as: MoveChecker
participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years or older
  • diagnosis of epilepsy (ICD code G40.x)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld

Bielefeld, North Rhine-Westphalia, 33617, Germany

Location

Epilepsiezentrum Kleinwachau

Radeberg, Saxony, 01454, Germany

Location

Evangelisches Krankenhaus Königin Elisabeth Herzberge

Berlin, 10365, Germany

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michael Domhardt, Dr.-Ing.

    GAIA AG (Sponsor)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 21, 2023

Study Start

February 27, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

DE(4)