Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05248269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2022-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thermocoagulation in Drug Resistant Focal Epilepsy
Sponsor:
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Organization:
Study Overview
Official Title:
Safety and Efficacy of Stereo-Electroencephalography Guided Thermocoagulation in Drug Resistant Focal Epilepsy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data.
Detailed Description:
Open-label, pilot, non-comparative, interventional cohort study. Each patient will be examined at least 8 times (8 visits will pass): Visit 0 - screening (within 14 days before Visit 1), Visit 1 (visit includes the procedure for the destruction of the epileptogenic focus), Visits 2 and 3 (after 1 and 2 days after Visit 1) - a repeated procedure for the destruction of the epileptogenic focus with an incomplete effect of the first procedure (not mandatory, carried out by the decision of the principal investigator), Visits 4-7 (7, 14, 30, 180 days after the procedure for the destruction of the epileptogenic focus).
Patients will be divided into 4 cohorts of 4 patients. Enrollment in the study of the next cohort of patients will be based on the safety analysis of the previous cohort 1 day after the manipulation.
After assessing the position of the electrodes based on the conjugation of brain MRI data before and after SEEG implantation and seizure recording, the ictal zone is determined. Thus, the localization of pathological activity is determined on the basis of neuroimaging data, as well as in accordance with the activity under certain contacts of the SEEG electrodes.
After explaining the treatment options to the patient and relatives, informed voluntary consent is taken for the implementation of this procedure.
Using a radio frequency generator Cosman RFG-G4, destruction is carried out at the necessary electrode contacts with a power of 3W, exposure time of 180 sec. In case of pain occurrence, the procedure is immediately terminated. After the procedure, the patient continues SEEG monitoring for 3 days.
If additional epileptogenic zones are identified, if necessary, a repeated thermocoagulation is performed (on the 2nd and 3rd days of the study). If there is no need for a second thermocoagulation, then Visits 2 and 3 are not performed. Next, the patient undergoes removal of the electrodes, a control MRI study is performed. Follow-up includes follow-up for 6 months. Visits 4-6 involve phone interviews with patients. During the conversation, the researcher should clarify complaints, general well-being, the presence and frequency of epileptic seizures over the period of time that has passed since the previous visit.
Patients will be divided into 4 cohorts of 4 patients. Enrollment in the study of the next cohort of patients will be based on the safety analysis of the previous cohort 1 day after the manipulation.
After assessing the position of the electrodes based on the conjugation of brain MRI data before and after SEEG implantation and seizure recording, the ictal zone is determined. Thus, the localization of pathological activity is determined on the basis of neuroimaging data, as well as in accordance with the activity under certain contacts of the SEEG electrodes.
After explaining the treatment options to the patient and relatives, informed voluntary consent is taken for the implementation of this procedure.
Using a radio frequency generator Cosman RFG-G4, destruction is carried out at the necessary electrode contacts with a power of 3W, exposure time of 180 sec. In case of pain occurrence, the procedure is immediately terminated. After the procedure, the patient continues SEEG monitoring for 3 days.
If additional epileptogenic zones are identified, if necessary, a repeated thermocoagulation is performed (on the 2nd and 3rd days of the study). If there is no need for a second thermocoagulation, then Visits 2 and 3 are not performed. Next, the patient undergoes removal of the electrodes, a control MRI study is performed. Follow-up includes follow-up for 6 months. Visits 4-6 involve phone interviews with patients. During the conversation, the researcher should clarify complaints, general well-being, the presence and frequency of epileptic seizures over the period of time that has passed since the previous visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: