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
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).
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Kliniki Neurochirurgii CSK UCK WUM | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Przemyslaw Kunert | Departments and Clinics of Emergency Medicine of the Medical University of Gdansk, NaoX Technologies, Warsaw Medical University Clinical Center |
Poland,
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 |
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