If successful, the study has potential implications for future surgical outcomes and patient experience among those with Parkinson disease.
Surgical Information Systems (SIS) recently announced a new post-marketed study, dubbed VISION (NCT05774041), that will evaluate whether use of the company’s SIS visualization technology can enhance the accuracy of deep brain stimulation (DBS) in patients with Parkinson disease (PD).1
The SIS System, an FDA-cleared visualization technology, provides patient-specific imaging for planned procedures like DBS that target the subthalamic nucleus (STN) and global pallidus internus (GPi). It utilizes standard clinical imaging (T1- and T2-weighted) MR images with validated accuracy of less than 1mm. VISION, a prospective, open-label study, will include 90 patients across several sites, with the aim of determining if using the SIS System results in less distance between the planned DBS target location and the actual implanted lead location.
"The VISION Study presents an opportunity to assist surgeons and programming physicians in treating patients with Parkinson's Disease," Patrick Senatus, MD, a neurosurgeon at Hartford Hospital in Hartford, Connecticut, said in a statement.1 "By enhancing visualization, the accuracy of DBS implant placement may be improved through further customizing targeting of therapeutic brain regions. I am enthusiastic about the possibilities that this research holds."
In VISION, adults with idiopathic PD indicated for de novo bilateral DBS surgery implant in the STN or GPi will be considered for study participation. In addition to measuring Euclidean distance between the planned target coordinate and actual implanted coordinate, the study will assess other outcomes of procedure-related adverse events (AEs), average duration of DBS surgery, and percentage of cases in which intra-operative testing was performed. Additionally, investigators will compare the width of the therapeutic window, change in average levodopa equivalent daily dosage, mean score on the Movement Disorder Society Unifed Parkinson’s Disease Rating Scale Part III, and percentage of motor benefit.
"Today marks a momentous occasion for SIS. We are proud to take the first step toward demonstrating improved outcomes of DBS surgery through patient specific visualization of target structures and lead placement,” Brad Swatfager, president and chief executive officer at SIS, said in a statement.1 "Our team has worked hard to develop this cutting-edge technology, and we look forward to collaborating with healthcare professionals across the country to explore its full potential and improve the experience for physicians and patients."
The SIS System requires no software to download, install or maintain. It runs on a cloud and allows users to upload pre- and postoperative imaging, with access from anywhere that is connected to a picture archiving and communication system (PACS). In addition, the system generates a patient-specific 3D model showing the position of the DBS lead and individual contacts in relation to anatomical structures. Visualization of the lead, ring, and directional connects relative to the DBS structures of interest thus allows for improved efficiency of programming.
In 2022, a study published in Frontiers in Neuroscience retrospectively assessed whether the stimulation site determined from the MRI-defined STN using the SIS System to visualize the individual patients’ STN, predicted the patient’s motor outcome. In the trial, anatomical models were generated using novel imaging in 40 patients with PD who had undergone bilateral STN DBS at another center.3
All told, results showed that the greatest improvement in hemi-body motor function was found when active contacts were located within the posterolateral (PL) portion of the STN (71.5%). Motor function improved in 90% (72 of 80) of implanted DBS locations. Further evaluation of electrodes near the PL segment demonstrated that motor function was improved by 72.2% (–13.1 points) for active contacts partially within the PL STN and 53.0% (–8.8 points) for active contacts just outside the PL STN. Overall, investigators recorded a mean reduction of 76.6% (–1271 mg) in levodopa equivalent daily dose at 1 year following DBS surgery.