Insightec, a global healthcare company specializing in MR-guided focused ultrasound (MRgFUS), announced the publication of pivotal clinical trial results in The Lancet Neurology. The prospective, multicenter study evaluated staged bilateral MRgFUS treatment for Parkinson's disease using Insightec's Exablate Neuro system. Results demonstrate that the incisionless procedure produces substantial and durable improvements in disabling motor symptoms, with benefits appearing within one month and sustained through 12 months.
Key Findings from the Study
The study is the first to systematically evaluate staged, bilateral MRgFUS in Parkinson's disease. It showed a 66.8% improvement in motor complications and a substantial reduction in the proportion of patients experiencing dyskinesia at three months. Patient-reported time spent with dyskinesia fell from approximately 75% of waking hours at baseline to just 14% after the second-side procedure. Overall motor complications improved by 66.8% three months after bilateral treatment, with benefits sustained through follow-up at 12 months.
Expert Commentary
“For people living with Parkinson's disease, the impact on daily life can be devastating and surgical options have been limited for far too long,” said Arif Dalvi, MD, Director of the Comprehensive Movement Disorders Center at Palm Beach Health Network and top-enrolling investigator of the study. “This study gives us the evidence-based guidance we've been waiting for, demonstrating that focused ultrasound treatment can deliver meaningful, lasting relief for Parkinson's that builds with each procedure. Importantly, it expands the role of this treatment beyond tremor, to address the motor fluctuations and involuntary movements that make daily life so difficult in later-stage Parkinson's.”
Study Design and Results
The prospective, multicenter trial enrolled 54 patients at nine investigational centers (six in the U.S., two in Spain, and one in Taiwan) and treated them between July 2021 and November 2023. Patients underwent a unilateral MRgFUS procedure followed by a second-side procedure at least six months later, using Insightec's Exablate Neuro system. The staged bilateral approach allowed researchers to systematically evaluate both the incremental and cumulative effects of bilateral treatment. Improvements in symptoms were seen within one month of treatment and maintained through the duration of the study (over two years from first side treatment). Most adverse events were mild to moderate; speech and gait effects were more frequent following second-side treatment, highlighting the importance of patient selection.
Additional Outcomes
- Motor complications improved by 66.8% at three months after bilateral treatment, with benefits sustained through follow-up.
- Primary motor endpoint improved 32.6% at three months after second-side treatment.
- Patient-reported time with dyskinesia fell from roughly 75% at baseline to 14% after second-side treatment.
- Mild to severe time spent in the OFF state, when medications are not working optimally, fell roughly 50%.
This study provides robust evidence that focused ultrasound can significantly improve the lives of Parkinson's patients, offering a non-invasive option with lasting benefits.
