NCT06366009

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Przemyslaw Kunert · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Focal Epilepsy
• Drug Resistant Epilepsy

Interventions

Type	Name	Description
DEVICE	NaoX 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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2024-04-15
• Last updated: 2024-04-15

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated device study