A staged bilateral MR-guided focused ultrasound treatment improved motor complications in patients with Parkinson’s disease, according to results published in The Lancet Neurology.
The prospective multicenter trial evaluated Insightec’s Exablate Neuro system for staged bilateral pallidothalamic tractotomy. It enrolled 54 patients at 9 investigational centers in the U.S., Spain, and Taiwan.
Patients first underwent a unilateral MRgFUS procedure. A second-side procedure followed at least 6 months later.
At 3 months after bilateral treatment, overall motor complications improved by 66.8%, according to Insightec’s summary of the published data. The primary motor endpoint improved by 32.6% at 3 months after the second-side procedure.
Patient-reported dyskinesia time fell from about 75% of waking hours at baseline to 14% after the second-side procedure. Time spent in the off state fell by about 50%.
Most adverse events were mild to moderate. Speech and gait effects were more frequent after second-side treatment, according to the company.
FDA records show that Exablate Neuro received approval in July 2025 for unilateral pallidothalamic tractotomy in advanced idiopathic Parkinson’s disease and staged second-side treatment at least 6 months after the first procedure. Patients must be at least 30 years old under the approved indication.
The FDA summary said the supporting clinical study was designed to establish reasonable assurance of safety and effectiveness for staged bilateral pallidothalamic tractotomy in patients with advanced idiopathic Parkinson’s disease and medication-refractory moderate to severe motor complications.
More than 30,000 patients have been treated with Exablate technology across 214 centers worldwide, including 104 in the U.S., according to Insightec.
Sources
About the author
RadiologySignal.com writersEditorial Team
Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
