Clinical trial NCT06366009: Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Focal Epilepsy
Drug Resistant Epilepsy
Keywords: in-ear EEG
EEG
epilepsy
focal epilepsy
drug resistant epilepsy
intra-auricular EEG
Lead sponsor: NaoX Technologies
Sponsor class: INDUSTRY
Collaborators: name: NaoX Technologies
name: Warsaw Medical University Clinical Center
name: Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk
First posted: 2024-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with drug-resistant focal epilepsy undergoing long-term EEG monitoring as part of the pre-surgical assessment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: determination of the starting point of focal temporal epileptic seizures
timeFrame: Day 5
Secondary outcomes:
measure: Identification of subgroups of epileptic patterns
timeFrame: Day 5
measure: Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician
timeFrame: Days 1-5
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Kliniki Neurochirurgii CSK UCK WUM
Study officials:
References: