Epilepsy Clinical Trial
Official title:
Safety and Efficacy of Stereo-Electroencephalography Guided Thermocoagulation in Drug Resistant Focal Epilepsy
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.
Status | Enrolling by invitation |
Enrollment | 16 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Pirogov National Medical and Surgical Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severe adverse reactions and events rate | Severe adverse reactions and events will be monitored and registered during procedure of thermocoagulation and up to 6 months after procedure | Up to 6 months after procedure | |
Primary | Seizure freedom or reduction after procedure | The incidence of seizures will be assessed and registered daily by patient in the diary for self-inspection. Records in the diary will be inspected by investigators during follow-up visits. | Up to 6 months after procedure | |
Secondary | Three-level European quality of life five-dimensional questionnaire | There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status. | Up to 6 months after procedure | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) Questionnaire | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality over a 1 month time frame. It consists of 19 individual elements, making up 7 components that give one overall rating. Each item is weighted on a scale from 0 to 3. The overall PSQI score is then calculated by adding the scores of the seven components to give an overall score of 0 to 21, where lower scores mean healthier sleep quality. | Up to 6 months after procedure | |
Secondary | Change of epileptiform activity on electroencephalography (EEG) study | EEG will be registered and reduction of epileptiform activity will be assessed (Beta, Theta, spikes, sharp waves). | Days 1, 7, 180 | |
Secondary | Beck Depression Inventory | This is a 21-question test that helps determine the psychological state of a person.
The score for each category is calculated as follows: each item on the scale is scored from 0 to 3 according to the increasing severity of the symptom. The total score ranges from 0 to 63 and decreases as the condition improves. The questionnaire is handed out to the patient and filled out by him independently. The results are evaluated depending on the number of points scored: 0-13 - variations considered normal 14-19 - mild depression 20-28 - moderate depression 29-63 - severe depression |
Up to 6 months after procedure |
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