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

P

Przemyslaw Kunert

Status

Not yet enrolling

Conditions

Drug Resistant Epilepsy
Epilepsy
Focal Epilepsy

Treatments

Device: NaoX in-ear EEG system

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT06366009
Warsaw Study

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Maja Kopytek-Beuzen, Dr.; Przemysław Kunert, Prof.

Data sourced from clinicaltrials.gov

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