Status:
ACTIVE_NOT_RECRUITING
Thermocoagulation in Drug Resistant Focal Epilepsy
Lead Sponsor:
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Conditions:
Epilepsy
Seizures, Focal
Eligibility:
All Genders
18-60 years
Phase:
NA
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 (SE...
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 (visi...
Eligibility Criteria
Inclusion
- Diagnosis of symptomatic drug-resistant epilepsy according to anamnesis, results of video EEG monitoring with registration of epileptic seizures.
- The epileptogenic zone verified using invasive electrodes.
- The patient has read the information sheet and signed the informed consent form.
- Non-inclusion Criteria:
- Persons with mental disorders.
- Women during pregnancy, childbirth.
- Women during breastfeeding.
- Reception of anticoagulants.
- Location of the epileptogenic focus within functionally significant areas, large vessels of the brain.
- Primary generalized forms of epilepsy.
Exclusion
- Absence of a registered seizure on stereo-EEG.
- Absence of a focal pattern during invasive stereo-EEG monitoring.
- Dropout Criteria:
- Refusal of the patient from observation
- The occurrence of contraindications that may prevent participation in diagnostic and treatment activities.
- Unwillingness or inability of the patient to comply with the requirements of the protocol, including the presence of any condition (physical, mental or social) that may affect his ability to comply with the requirements of the study
- Identification of conditions during the study that meet the exclusion criteria for non-inclusion of patients.
- Lack of effect from thermocoagulation within a month after manipulation or worsening of the condition associated with an increase in the number/severity of epileptic seizures.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05248269
Start Date
February 7 2022
End Date
December 1 2024
Last Update
July 23 2024
Active Locations (1)
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1
Pirogov National Medical and Surgical Center
Moscow, Russia, 105064