Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT05248269
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of symptomatic drug-resistant epilepsy according to anamnesis, results of video EEG monitoring with registration of epileptic seizures.
2. The epileptogenic zone verified using invasive electrodes.
3. The patient has read the information sheet and signed the informed consent form.
Non-inclusion Criteria:
1. Persons with mental disorders.
2. Women during pregnancy, childbirth.
3. Women during breastfeeding.
4. Reception of anticoagulants.
5. Location of the epileptogenic focus within functionally significant areas, large vessels of the brain.
6. Primary generalized forms of epilepsy.
Exclusion Criteria:
1. Absence of a registered seizure on stereo-EEG.
2. Absence of a focal pattern during invasive stereo-EEG monitoring.
Dropout Criteria:
1. Refusal of the patient from observation
2. The occurrence of contraindications that may prevent participation in diagnostic and treatment activities.
3. 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
4. Identification of conditions during the study that meet the exclusion criteria for non-inclusion of patients.
5. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05248269
Study Brief:
Protocol Section:
NCT05248269