Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes

Not yet recruiting

• Conditions: Epilepsy; Drug Resistant Epilepsy; Focal Epilepsy

• Registration Number: NCT06366009
• Lead Sponsor: Przemyslaw Kunert

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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-08
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Kliniki Neurochirurgii CSK UCK WUM; 🇵🇱 Warsaw, Poland