EpilepsyNCT05824611
Formative Validation of the MoveChecker System
An observational study of Epilepsy, run by Gaia AG at 4 sites in Germany.
Trial summary
obtain motion sequences of at least 60 epileptic seizures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- collect movement data from epileptic seizures
- How many people
- 53 participants
- Where
- 4 sitesGermany
- Study dates
- 27 Feb 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are included in special care clinics (epilepsy monitoring units), study inclusion is confirmed by a physician at the clinic
Who may be able to join
- 18 years or older
- diagnosis of epilepsy (ICD code G40.x)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Evangelisches Krankenhaus Königin Elisabeth Herzberge
Berlin, 10365
Krankenhaus Mara Universitätsklinikum OWL der Universität Bielefeld
Bielefeld, North Rhine-Westphalia, 33617
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Epilepsiezentrum Kleinwachau
Radeberg, Saxony, 01454
About this study
obtain motion sequences of at least 60 epileptic seizures
Read the 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.
- Conditions
- Epilepsy
- Being tested
- collect movement data from epileptic seizures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect movement data from epileptic seizuresOther
Also called MoveChecker
non-invasive recording of movement data during care as usual
| Study group | Role | What they receive |
|---|---|---|
| participants | patients with epilepsy included in the study at one of the study locations Receives: Other: collect movement data from epileptic seizures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 days
Secondary outcomes (1)
qualitative assessment of the clinical benefit of the system
Semi-standardised interviews with clinical staff and patients
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Domhardt, Dr.-Ing., Principal investigator, GAIA AG (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824611
- Sponsor's protocol ID
- MoveChecker Form. Validation
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Validation of the MoveChecker System
- ClinicalTrials.gov ID
- NCT05824611
- Acronym / sponsor ID
- MoveChecker Form. Validation
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
obtain motion sequences of at least 60 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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | – | Other: collect movement data from epileptic seizurespatients with epilepsy included in the study at one of the study locations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are included in special care clinics (epilepsy monitoring units), study inclusion is confirmed by a physician at the clinic
Key inclusion criteria (2 listed)
- 18 years or older
- diagnosis of epilepsy (ICD code G40.x)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collect movement data from epileptic seizuresAlso: MoveCheckernon-invasive recording of movement data during care as usual | Other | participants |
Primary outcome
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
1 secondary outcome
qualitative assessment of the clinical benefit of the system
Time frame: through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Domhardt, Dr.-Ing. principal investigator
GAIA AG (Sponsor)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Gaia AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motion sequences of at least 60 epileptic seizures (time frame: up to 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.