Clinical Research Directory

Inclusion Criteria: * male or female aged from 3 months up to 50 years at the day of randomization * patients/parents/caregivers are willing to and able to give informed consent form for the participation in the study * patients/parents/caregivers are willing to and able to comply with all study requirements * definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013) * drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks Exclusion Criteria: * history of treatment with mTOR inhibitor in the three months prior to screening, * history of pseudo-epileptic seizures, * history of progressive CNS disease other than TSC * recent surgery within 2 weeks prior to the screening * severe infection within 2 weeks prior to the screening * use of the cannabis derivatives * contraindications for MRI or general anesthesia * occurrence of the serious comorbidities which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study the investigator * pregnancy