Pilot Evaluation of Non-Invasive Low Intensity Focused Ultrasound Device for Adults with Drug-Resistant Epilepsy Aged 21 to 65

What this Trial Is About

Researchers are studying the effects of non-invasive, low intensity focused ultrasound LIFU stimulation on seizure frequency and brain activity in adults with drug-resistant epilepsy. This trial aims to understand how LIFU can modulate deep brain regions involved in seizures, using electroencephalography EEG and behavioral tasks to observe changes in brain networks. The study includes adults aged 21 to 65 who experience frequent seizures despite medication. Participants will undergo a series of LIFU sessions using the ATTN201 wearable device, which targets personalized brain areas based on MRI scans to optimize treatment response. The study uses a within-subject, randomized, sham-controlled design, meaning each participant receives both active and placebo sham LIFU during different sessions. If an optimal brain target is found, participants will then receive repeated LIFU stimulation at that target over several months. During the approximately four-month study period, participants will track seizure counts daily for at least one month before starting and continue throughout the study and for two months after. Brain network changes will be assessed using functional MRI and electrophysiology at baseline and after serial stimulation. Cognitive tests will be performed at multiple points to monitor effects. Participants will wear the LIFU device as a headband and complete scheduled visits and seizure logs to help researchers measure seizure frequency and brain changes.

Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy