Thermocoagulation in Drug Resistant Focal Epilepsy

Epilepsy Clinical Trial

Official title: Safety and Efficacy of Stereo-Electroencephalography Guided Thermocoagulation in Drug Resistant Focal Epilepsy

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Epilepsy Intractable
• Seizures
• Seizures, Focal

• NCT number: NCT05248269
• Study type: Interventional
• Source: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 7, 2022
• Completion date: December 1, 2024