Aug 29: Results from a pilot clinical trial evaluating the safety and feasibility of focused ultrasound neuromodulation in patients with drug-resistant epilepsy were published in Epilepsia. Led by Hsiang-Yu Yu, MD, a neurologist at Taipei Veterans General Hospital in Taiwan, this study built upon the group’s initial clinical research with six participants.
The clinical trial (NCT04999046) enrolled 12 adult participants between January 2022 and March 2024 who received low-intensity focused ultrasound neuromodulation using the NaviFUS neuronavigation-guided device. The brain target was personalized to each participant’s seizure onset zone, which was localized through clinical examination, MRI, positron emission tomography, and electroencephalographic testing, among other methods.
The team used treatment parameters determined by preclinical studies that suppressed epileptiform activity without tissue injury and the group’s previous first-in-human study of LIFU neuromodulation in this population (i.e., a spatial peak temporal average intensity of 0.3 Watts per square centimeter [mechanical index = 0.25], corresponding to a peak pressure of 0.18 megapascals, and a root-mean-square pressure of 0.12 megapascals). Participants underwent three consecutive 5-minute sonications separated by two 5-minute intermissions during each LIFU session. The ultrasound was delivered using a 3-millisecond burst length, 30% duty cycle, and 100-hertz pulse repetition frequency.
The trial was designed as a randomized and sham-controlled study, meaning that some participants were initially given a placebo treatment. Sham treatment workflow mirrored that of the treatment in setup and time length, but no energy was delivered while prerecorded background sounds that simulated sonication noises were played. Those in the sham cohort could then opt to crossover and receive the actual LIFU treatment after the initial follow-up period. After completion of crossover, the follow-up period was extended to further monitor seizure outcomes.
The authors made the following conclusions:
- The procedure accurately targeted the seizure onset zone of each individual participant.
- LIFU neuromodulation with the NaviFUS device was safe and well tolerated, with no serious adverse events or tissue damage.
- While the primary crossover analysis did not show a statistically significant antiseizure effect, further studies are needed to confirm efficacy and optimize treatment parameters.
“This study represents an important step in the clinical translation of focused ultrasound for epilepsy,” said Arthur Lung, PhD, chairman of NaviFUS. “Our goal is to continue building the clinical evidence needed to make precise, noninvasive brain neuromodulation a meaningful treatment option for patients with drug-resistant epilepsy.
This investigator-initiated study was funded by NaviFUS, but the company had no further involvement beyond providing technical support.