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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.