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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366009
• Other study ID #: Warsaw Study
• Status: Not yet recruiting
• Start date: April 8, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: NaoX Technologies
• Contact: Przemyslaw Kunert, Prof.
• Phone: 0048 22 599 1575
• Email: przemyslaw.kunert[@]uckwum.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Epilepsy, Temporal Lobe
• Focal Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Poland	Kliniki Neurochirurgii CSK UCK WUM	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Przemyslaw Kunert	Departments and Clinics of Emergency Medicine of the Medical University of Gdansk, NaoX Technologies, Warsaw Medical University Clinical Center

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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