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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Drug Resistant Epilepsy; Focal Epilepsy
• Intervention / Treatment: Device: NaoX in-ear EEG system

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Przemysław Kunert, Prof.; Phone Number: 0048 22 599 1575; Email: przemyslaw.kunert@uckwum.pl
• Study Contact Backup: Name: Maja Kopytek-Beuzen, Dr.; Phone Number: 0048 22 599 2575; Email: maja.beuzen@uckwum.pl

Study Locations

• Poland
  • Warsaw, Poland
    • Kliniki Neurochirurgii CSK UCK WUM
    • Contact: Przemysław Kunert, Prof.
    • Contact: Maja Kopytek-Beuzen, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Days 1-5

Collaborators and Investigators

• Sponsor: Przemyslaw Kunert
• Collaborators: NaoX Technologies; Warsaw Medical University Clinical Center; Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; EEG; focal epilepsy; drug resistant epilepsy; in-ear EEG; intra-auricular EEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsy; Epilepsies, Partial; Drug Resistant Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: Warsaw Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No