Pilot Study of NaviFUS System Low-Intensity Focused Ultrasound Treatment for Adults With Drug-Resistant Epilepsy Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating a device called the NaviFUS System, which uses low-intensity focused ultrasound LIFU neuromodulation to study its effects on patients with drug-resistant epilepsy DRE. This condition involves seizures that have not improved despite trying at least three anti-seizure medications. The study is designed as a pilot, open-label, randomized trial to understand the safety and ability of the device to reduce seizure activity by targeting specific brain regions. Participants in this study will be divided into two groups receiving different doses of the ultrasound treatment. One group will receive three consecutive 5-minute treatments twice a week, while the other group will receive three consecutive 10-minute treatments twice a week. Both treatments use specific ultrasound parameters controlled by the NaviFUS System. Following the treatments, there will be a 24-week follow-up period. Throughout the study, patients may continue their usual anti-seizure medications. Before treatment, participants will undergo an 8-week screening period where they keep a seizure diary to establish a baseline of seizure frequency and severity. This diary will continue throughout the treatment and follow-up periods. Researchers will monitor seizure frequency changes, seizure-free days, seizure strength, quality of life, anxiety, and depression levels. Safety will also be closely observed by tracking any adverse events during the study, which will last up to 33 weeks in total.

A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy