Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

This pivotal study is testing the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) — a form of non-invasive brain stimulation that applies a gentle electrical current through electrodes placed on the scalp — as a treatment for refractory focal epilepsy. Refractory epilepsy means seizures continue despite trying at least two appropriate seizure medications. Patients with this condition often have very limited treatment options and can experience dozens of seizures a month. tDCS delivers a weak electrical current to the brain region responsible for generating seizures, with the goal of reducing the brain's tendency to fire abnormally. It is painless and can be applied without surgery. The study aims to determine whether tDCS can meaningfully reduce seizure frequency and whether it is safe. You may be eligible if... - You are 9 years or older - You have a confirmed diagnosis of focal epilepsy with at least 3 seizures per month for the past year - Your epilepsy has not been adequately controlled by at least 2 appropriate seizure medications (refractory) - Your seizure focus can be clearly identified and is localized to one hemisphere and one or two adjacent lobes - You are on a stable anti-seizure medication regimen for at least 3 weeks before the study baseline You may NOT be eligible if... - You have more than one seizure focus - Your seizure focus is in certain locations (interhemispheric, cingulate, orbitofrontal) - You have had status epilepticus (prolonged seizure) in the past 12 months - You are pregnant or refuse to use contraception during the study - You have a cranial metal implant (except titanium skull plates ≤1mm or dental fillings) or an incompatible medical device - You have had skull surgery leaving large defects - You have a history of substance addiction Talk to your doctor to see if this trial is right for you.