Epilepsy pilot finds focused ultrasound safe, efficacy unproven

For each treatment session, adults with drug-resistant epilepsy received three consecutive 5-minute bursts of ultrasound, with two 5-minute breaks between them. At Taipei Veterans General Hospital in Taiwan, Hsiang-Yu Yu and his team aimed the energy at each person’s seizure-onset zone using the NaviFUS neuronavigation-guided device. The pilot trial enrolled 12 participants between January 2022 and March 2024.

The technology was low-intensity focused ultrasound, or LIFU: sound energy directed toward a selected brain region to modulate its activity without surgery. The target was personalized using clinical examination, MRI, positron emission tomography and electroencephalographic testing, among other methods. Treatment settings came from preclinical work that suppressed epileptiform activity without tissue injury and from the group’s earlier first-in-human study in this population.

The trial was randomized and sham-controlled. Some participants first underwent a session that matched the treatment’s setup and duration, with recorded sounds simulating the ultrasound but no energy delivered. After the initial follow-up, those participants could cross over to receive LIFU, followed by extended monitoring of seizure outcomes.

The safety signal was clear in this small study: the researchers said the device accurately reached the intended seizure-onset zones and was well tolerated, with no serious adverse events or tissue damage. The efficacy signal was not. The primary crossover analysis found no statistically significant antiseizure effect, so the authors say further studies must confirm whether the treatment reduces seizures and determine the best parameters.

So what changes in practice? Not yet the treatment options available to patients. The finding supports a next step: testing whether a precisely targeted, noninvasive brain-stimulation approach can produce an antiseizure benefit in further studies with optimized parameters. For now, the evidence establishes feasibility and safety in this pilot, while leaving effectiveness unresolved.