Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366009
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes
Sponsor:
Przemyslaw Kunert
Organization:
NaoX Technologies
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 dont 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 T9T10 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
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 dont 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 T9T10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None