Focused Ultrasound for Epilepsy: Clinical Trial Begins in Australia
Key Points
- The study is testing NaviFUS’s neuronavigation-guided focused ultrasound system for treating patients with drug-resistant epilepsy.
- Up to 18 participants will be treated in Melbourne.
A new clinical trial is testing the use of NaviFUS’s neuronavigation-guided focused ultrasound system for the treatment of patients with drug-resistant epilepsy. The study is being led by Professor Terence O’Brien, a specialist in neurology and clinical pharmacology at Alfred Health in Melbourne, Australia.
Current anti-seizure medications are not effective for all patients with epilepsy, and for those who do not respond to medication, the standard of care is to surgically remove portions of the brain associated with the seizures. However, some patients are not candidates for traditional surgery, which also carries inherent risks (e.g., infection).
The NaviFUS device uses real-time neuronavigation guidance to direct focused ultrasound energy precisely and noninvasively through the skull to select brain tissues without surgery.
In this research study, up to 18 participants will undergo low-intensity focused ultrasound to generate neuromodulation effects to zones deep in the brain called the hippocampi that are associated with seizures. The goal is to decrease the number of seizures.
The participants will be divided into two cohorts. The difference between the cohorts is the number of weeks of treatment; the first group will undergo two weeks of treatment, and the second cohort will be treated over three weeks. A safety monitoring committee will review all safety data for Cohort 1 to determine whether it is safe to proceed with Cohort 2.
The current trial builds on pilot study data published in 2021 that showed no significant adverse events and decreased seizure frequency in a small number of patients.
“NaviFUS is hopeful that this trial will identify the most effective treatment duration and frequency for patients with drug-resistant epilepsy, ultimately aiming to achieve the optimal therapeutic benefit with the least burden on patients,” said the company’s CEO Arthur Lung, PhD. “For the significant population suffering from drug-resistant epilepsy, this research offers the potential for a noninvasive solution that could be safely administered long-term, providing much-needed relief from seizures and improving their quality of life.”
For Patients
Those interested in learning more about this trial are encouraged to contact Caitlin Roberts at +61 3 9076 2598 or cai.roberts@alfred.org.au.
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