Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06366009
Other study ID # Warsaw Study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A