Drug Resistant Epilepsy, Epilepsy, Focal Epilepsy
Conditions
Keywords
in-ear EEG, EEG, epilepsy, focal epilepsy, drug resistant epilepsy, intra-auricular EEG
Brief 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).
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.
Interventions
DEVICENaoX in-ear EEG system
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.
Sponsors
NaoX Technologies
Warsaw Medical University Clinical Center
Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk
Przemyslaw Kunert
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determination of the starting point of focal temporal epileptic seizures | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of subgroups of epileptic patterns | Day 5 | 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 |
| Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician | Days 1-5 | Questionnaire to EEG technician and patient |
Countries
Poland
Contacts
Primary ContactPrzemysław Kunert, Prof.
Backup ContactMaja Kopytek-Beuzen, Dr.
Outcome results
None listed