EpilepsyNCT06366009
Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes
An observational study of Epilepsy and Focal Epilepsy, run by Przemyslaw Kunert at 1 site in Poland.
Trial summary
The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Focal Epilepsy, Drug Resistant Epilepsy
- What is being tested?
- NaoX in-ear EEG system
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 8 Apr 2024to 31 Jul 2024
- 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: Subjects with drug-resistant focal epilepsy undergoing long-term EEG monitoring as part of the pre-surgical assessment.
Who may be able to join
- Age > 18 years
- Diagnosis of drug-resistant epilepsy
- Sufficient level of cooperation to use of the NAOX in-ear EEG system
- Providing informed consent to participate in the study
Who cannot join
- Presence of skull bone defects, e.g. after prior neurosurgery
- Presence of comorbidities that may significantly affect the resting EEG
- Medical history strongly suggestive of psychogenic nonepileptic attacks
Trial locations and contacts
1 site in 1 country.
Poland1 site
Kliniki Neurochirurgii CSK UCK WUM
Warsaw
Przemysław Kunert, Prof.
Maja Kopytek-Beuzen, Dr.
About this study
Official title: Evaluation of the Use of Video EEG Examination Extended With Intra-auricular Electrodes in the Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy
The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE).
Read the detailed description
This study is a monocentric observational study aiming to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE).
30 subjects with drug-resistant focal epilepsy undergoing long-term EEG monitoring as part of the pre-surgical assessment will be included.
All patients referred to the UCK WUM Department of Neurosurgery for video EEG monitoring will be subject to prescreening. Those who, according to prior medical documentation, don't meet exclusion criteria and are likely to meet inclusion criteria will be invited to participate in the study and will undergo an initial assessment in form of a structured interview with a clinician, EEG recordings will be carried out simultaneously using standard EEG equipment (full set of electrodes according to the 10-20 system extended by additional temporal electrodes T9/T10) and the NAOX in-ear EEG system device.
EEG monitoring will take place for 5 days of hospitalization according to the standard protocol of the Video-EEG Laboratory of the Department of Neurosurgery, CSK UCK, Medical.
- Conditions
- Epilepsy, Focal Epilepsy, Drug Resistant Epilepsy
- Being tested
- NaoX in-ear EEG system
- Keywords
- in-ear EEG, EEG, epilepsy, focal epilepsy, drug resistant epilepsy, intra-auricular EEG
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaoX in-ear EEG systemDevice
Also called NaoX Buds, standard EEG
EEG recordings will be carried out simultaneously using standard EEG equipment (full set of electrodes according to the 10-20 system extended by additional temporal electrodes T9/T10) and the NAOX in-ear EEG system device.
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of the starting point of focal temporal epileptic seizures
correlation of the seizure onset zone encompassing intra-auricular electrodes with the clinically determined location of the focus within the medial temporal lobe
Measured: Day 5
Secondary outcomes (2)
Identification of subgroups of epileptic patterns
Identification of subgroups of epileptic patterns which, depending on the location of the epileptic focus may be more clearly visible at intra-auricular sites than in standard 10-20 system electrode locations, may be visible exclusively at intra-auricular locations, may not be visible at intra-auricular location
Measured: Day 5
Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician
Questionnaire to EEG technician and patient
Measured: Days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start8 Apr 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Przemyslaw Kunert
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NaoX Technologies, Warsaw Medical University Clinical Center, Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk
- Responsible party
- Sponsor-investigator, Przemyslaw Kunert, NaoX Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366009
- Sponsor's protocol ID
- Warsaw Study
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Video EEG Examination Extended With Intra-auricular Electrodes in the Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT06366009
- Acronym / sponsor ID
- Warsaw Study
- Conditions
- Epilepsy, Focal Epilepsy, Drug Resistant Epilepsy
- Keywords
- in-ear EEG, EEG, epilepsy, focal epilepsy, drug resistant epilepsy, intra-auricular EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Przemyslaw KunertIndustry (pharma, biotech, devices)
- Collaborators
- NaoX Technologies, Warsaw Medical University Clinical Center, Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk
- Study start
- 8 Apr 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 15 Apr 2024 (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 study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE).
Detailed description
This study is a monocentric observational study aiming to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE).
30 subjects with drug-resistant focal epilepsy undergoing long-term EEG monitoring as part of the pre-surgical assessment will be included.
All patients referred to the UCK WUM Department of Neurosurgery for video EEG monitoring will be subject to prescreening. Those who, according to prior medical documentation, don't meet exclusion criteria and are likely to meet inclusion criteria will be invited to participate in the study and will undergo an initial assessment in form of a structured interview with a clinician, EEG recordings will be carried out simultaneously using standard EEG equipment (full set of electrodes according to the 10-20 system extended by additional temporal electrodes T9/T10) and the NAOX in-ear EEG system device.
EEG monitoring will take place for 5 days of hospitalization according to the standard protocol of the Video-EEG Laboratory of the Department of Neurosurgery, CSK UCK, Medical.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with drug-resistant focal epilepsy undergoing long-term EEG monitoring as part of the pre-surgical assessment.
Key inclusion criteria (4 listed)
- Age > 18 years
- Diagnosis of drug-resistant epilepsy
- Sufficient level of cooperation to use of the NAOX in-ear EEG system
- Providing informed consent to participate in the study
Key exclusion criteria (3 listed)
- Presence of skull bone defects, e.g. after prior neurosurgery
- Presence of comorbidities that may significantly affect the resting EEG
- Medical history strongly suggestive of psychogenic nonepileptic attacks
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 |
|---|---|---|
| NaoX in-ear EEG systemAlso: NaoX Buds, standard EEGEEG recordings will be carried out simultaneously using standard EEG equipment (full set of electrodes according to the 10-20 system extended by additional temporal electrodes T9/T10) and the NAOX in-ear EEG system device. | Device | – |
Primary outcome
determination of the starting point of focal temporal epileptic seizures
Time frame: Day 5
correlation of the seizure onset zone encompassing intra-auricular electrodes with the clinically determined location of the focus within the medial temporal lobe
2 secondary outcomes
Identification of subgroups of epileptic patterns
Time frame: Day 5
Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician
Time frame: Days 1-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Focal Epilepsy, run by Przemyslaw Kunert at 1 site in Poland.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Przemysław Kunert, Prof. (0048 22 599 1575, przemyslaw.kunert@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of the starting point of focal temporal epileptic seizures (time frame: Day 5). 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 15 Apr 2024.