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

NCT06366009 | Not Yet Recruiting FDA Device

• 1 other identifier: Warsaw Study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Epilepsy; Focal Epilepsy; Drug Resistant Epilepsy

Keywords

in-ear EEG; EEG; epilepsy; focal epilepsy; drug resistant epilepsy; intra-auricular EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identification of subgroups of epileptic patterns

  Day 5

• 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

Interventions

NaoX in-ear EEG system DEVICE

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.

Also known as: NaoX Buds, standard EEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Przemyslaw Kunert: lead
• NaoX Technologies: collaborator
• Warsaw Medical University Clinical Center: collaborator
• Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk: collaborator

Study Sites (1)

Kliniki Neurochirurgii CSK UCK WUM

Warsaw, Poland

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Przemysław Kunert, Prof.

CONTACT

0048 22 599 1575; przemyslaw.kunert@uckwum.pl

Maja Kopytek-Beuzen, Dr.

CONTACT

0048 22 599 2575; maja.beuzen@uckwum.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. Hab.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 8, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)