The purpose of the feasibility (early stage) study is to evaluate the effectiveness and safety of an investigational device used to treat seizures that are not well controlled by medication and are due to a small growth of abnormal cells in the middle of the brain, most commonly hypothalamic hamartomas, subcortical nodules, or tuberous sclerosis. The device sends ultrasound waves into the abnormal area of the brain and ablates (or kills) the cells that may be causing epilepsy.
You may be eligible for this study if: You have seizures due to an abnormal growth of cells in the middle of your brain. You have tried at least 3 drugs to treat epilepsy and none of the drugs have helped to control your seizures. You have 3 or more seizures a month and are currently taking 2 medications to treat your seizures.
Participation involves one screening visit to make sure you are eligible for the study and explain the procedures, one overnight hospitalization when you receive the ultrasound study treatment, and four follow-up study visits over a 12 month period of time. Each clinic visit will last about two to four hours. You will have blood drawn for lab tests, MRI and CT scan of your brain. Additionally, you will answer questions about your health, medications, complete questionnaires and keep a seizure diary.
All of the procedures in this study will be provided at no cost to you or your health insurance.
Ages: 18 – 80 years