Thermocoagulation in Drug Resistant Focal Epilepsy (NCT05248269) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thermocoagulation in Drug Resistant Focal Epilepsy
Russia75 participantsStarted 2022-02-07
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Absence of a registered seizure on stereo-EEG.
✕. Absence of a focal pattern during invasive stereo-EEG monitoring.
✕. 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
What they're measuring
1
Severe adverse reactions and events rate
Timeframe: Up to 6 months after procedure
2
Seizure freedom or reduction after procedure
Timeframe: Up to 6 months after procedure
Trial details
NCT IDNCT05248269
SponsorState Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
✕. 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.