A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

This is an open-label prospective intervention study. Ten (10) adults with refractory, focal epilepsy with secondary generalization and able to provide informed consent will undergo focused ultrasound (FUS) thalamotomy. In addition to the diagnosis of medically refractory epilepsy, these patients will need to meet protocol specific inclusion and exclusion criteria. These adults will be screened from the patients being cared for by the epilepsy program at the University of North Carolina at Chapel Hill or referred from elsewhere for enrollment in the study. Initially, 3 participants will be enrolled and followed for 3 months to assess the safety of study intervention. Pending review by the Data and Safety Monitoring Committee (DSMC) and the US Food and Drug Administration (FDA), additional subjects will be enrolled. This pilot study is being conducted to test the feasibility of this device in order to confirm the design and operating specifications of the device including the ability to identify and accurately ablate the target focus within the Anterior Nucleus. Safety will be assessed by the frequency of side effects, e.g., new onset of neurological deficits, performance deterioration on neuropsychological testing. Feasibility is defined as the ability to create the desired lesion within the anterior nucleus. Seizure frequency data will be collected by seizure questionnaire. Quality of life will be measured by the Quality of Life in Epilepsy Inventory (QOLIE-31). Imaging analysis will include a comparison of pre- and post-intervention imaging to identify brain networks associated with clinical outcomes and determine changes in resting-state functional connectivity (assessed by fMRI), as well as in structural (assessed by volumetric T1 and T2 weighted imaging) and microstructural (assessed by diffusion tensor imaging) brain anatomy. Subject satisfaction with FUS thalamotomy will be assessed by the Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19).