Absence SeizuresECVNCT04615442
ECV - Epihunter Clinical Validation
A study testing Epihunter in people with Absence Seizures and Absence Epilepsy, run by Epihunter NV at 4 sites in 4 countries.
Trial summary
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Absence Seizures, Absence Epilepsy
- What is being tested?
- Epihunter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 May 2020to 31 Dec 2021
- Phase
- Interventional
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects should have an indication of having absence seizures
- Subjects should be admitted for video EEG monitoring as part of their clinical practice
- Age > 4 years
Who cannot join
- Head circumference should be compatible for wearable EEG device (40-70cm)
- The subject should be able to understand instructions and refrain from removing the device from its head
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.
- Conditions
- Absence Seizures, Absence Epilepsy
- Being tested
- Epihunter
- Medical subject headings
- Seizures, Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpihunterDevice
Subjects wear epihunter during routine video EEG
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG. Receives: Device: Epihunter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for electrographic seizures of study device compared to video EEG
The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is > 0.90 (median sensitivity per patient)
Measured: 9 months
Number of false alarms by study device per hour
The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording)
Measured: 9 months
Secondary outcomes (1)
Feasibility testing of automated behavioral testing triggered by automated detection
Assess if automated behavioral testing triggered by automated detection can be used to automatically assess awareness during an absence seizure. Successful if subjects DO NOT react to the testing during an unaware seizure, and DO react during an aware seizure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 May 2020
- Primary completion28 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absence SeizuresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epihunter NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Filadelfia Epilepsy Hospital, KU Leuven, Boston Children's Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia
- Responsible party
- Sponsor
- Investigators
- Dirk Loeckx, PhD, Principal investigator, Epihunter NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615442
- Sponsor's protocol ID
- EPI2019B
- Acronym
- ECV
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2020
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECV - Epihunter Clinical Validation
- ClinicalTrials.gov ID
- NCT04615442
- Acronym / sponsor ID
- ECV / EPI2019B
- Conditions
- Absence Seizures, Absence Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Epihunter NVIndustry (pharma, biotech, devices)
- Collaborators
- Filadelfia Epilepsy Hospital, KU Leuven, Boston Children's Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Nov 2020 (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.
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: EpihunterSubjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects should have an indication of having absence seizures
- Subjects should be admitted for video EEG monitoring as part of their clinical practice
- Age > 4 years
Key exclusion criteria (2 listed)
- Head circumference should be compatible for wearable EEG device (40-70cm)
- The subject should be able to understand instructions and refrain from removing the device from its head
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 |
|---|---|---|
| EpihunterSubjects wear epihunter during routine video EEG | Device | All subjects |
Primary outcome
Sensitivity for electrographic seizures of study device compared to video EEG
Time frame: 9 months
The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is > 0.90 (median sensitivity per patient)
Number of false alarms by study device per hour
Time frame: 9 months
The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording)
1 secondary outcome
Feasibility testing of automated behavioral testing triggered by automated detection
Time frame: 3 months
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 4 Apr 2022.
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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.
Dirk Loeckx, PhD principal investigator
Epihunter NV
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epihunter in people with Absence Seizures and Absence Epilepsy, run by Epihunter NV at 4 sites in 4 countries.
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 3 inclusion and 2 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 4 Apr 2022. 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 United States, Belgium, Denmark, Georgia. 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?
Sensitivity for electrographic seizures of study device compared to video EEG (time frame: 9 months). The study lists 2 primary outcomes in all. 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 4 Apr 2022.