This safety study is the first step to assess if this approach could treat epilepsy disorders. The study is being conducted using a brain system with a single-element transducer developed by Brain Sonix and is funded through a grant from the Dorothy and Gerald R. Friedman Foundation.
The 12 patients in the study will be administered focused ultrasound simultaneously along with functional MRI (fMRI), using different ultrasound intensities and parameters to determine any effects on the fMRI signal, indicating changing brain activity. All participants in the study will be those with intractable epilepsy who are already scheduled for temporal lobectomy. The research team will analyze the removed tissue to determine the presence of anatomic changes from the focused ultrasound.
“The focused sound waves are essentially vibrating the cell membrane and changing the electrical property of the neurons,” says study Co-Investigator Alex Korb, PhD, adjunct assistant professor in the department of psychiatry at UCLA. “The goal is to develop a technology that could push the neurons toward normal activity instead of the hyperactive epileptic state.”
The FDA requested that the first two patients be treated at a very low intensity, to verify safety before proceeding. These first patients have already participated with no evidence of damage, so the team has FDA clearance to increase the intensity of the focused ultrasound when treating additional subjects.
“Temporal lobe epilepsy is one of the more common forms of the disease that is medication resistant, and many patients have to eventually resort to surgery. The ultimate goal of focused ultrasound would be to augment or replace surgery with a far less invasive and safer treatment option,” added Korb.
The study, led by UCLA neurologist Dr. John Stern, is initially recruiting patients in Southern California, but their scope may expand. To find out more, visit clinicaltrials.gov.