The PROGRESS study has achieved its primary endpoint and demonstrated superiority of the therapeutic window using Abbott directional stimulation compared to omnidirectional stimulation. Results showed a reduction in the energy required to achieve meaningful therapeutic benefit in patients using Abbott’s Infinity deep brain stimulation system (DBS).
The post-market PROGRESS study is the largest study of its kind and is evaluating Abbott’s Infinity DBS system’s directional leads versus traditional stimulation for the treatment of patients with Parkinson’s disease.
The initial study results demonstrated that PROGRESS achieved its primary endpoint of superiority of the “therapeutic window” with the Abbott directional DBS lead, which is the range of stimulation that achieves symptom relief without disruptive side effects, in patients when using directional DBS. Importantly, patients were able to achieve meaningful symptom relief with lower amounts of therapeutic stimulation.
“While we have known about the technological benefits of directional leads since Abbott pioneered the technology a few years ago, we now have the first release of data to confirm the benefits of this technology over traditional omnidirectional lead technology in expanding the therapeutic window for a majority of patients,” said Matthew Brodsky, medical director of Oregon Health and Science University’s deep brain stimulation program and primary investigator of the trial. “These data are very encouraging as they further reinforce that directional deep brain stimulation therapy may benefit a wide variety of patients living with Parkinson’s disease.”
More than 10 million people are living with Parkinson’s disease worldwide. The disease is caused by a communication breakdown throughout the central nervous system that can result in a debilitating loss of muscle control, involuntary movement, and reduced coordination.
Abbott’s Infinity DBS system for the management of Parkinson’s disease was the first system available in the USA with directional leads and is different from traditional stimulation. The system is designed to steer electrical current toward targeted areas of the brain to lessen symptoms, such as tremors, through segmented, directional lead technology, delivering therapy more efficiently.
The system also provides patients with an intuitive and low maintenance way to discreetly manage their symptoms by combining advanced directional lead technology with a wireless Apple consumer device. This allows for upgrades without the need for surgery and the advanced platform that helps simplify the programming process for physicians. By using the Therapeutic Window Percentage-Based Ranking in the Informity programming software, clinicians can easily identify optimal programming settings to steer the current and use the least amount of energy required.
About the PROGRESS trial
Alongside strong real-world patient outcomes with the company’s directional DBS leads, Abbott launched the PROGRESS study to further evaluate the therapeutic window provided by the technology over traditional omnidirectional leads. Up to 235 patients with bilateral deep brain stimulation for Parkinson’s disease will be enrolled as part of the PROGRESS study, which is being conducted at 37 sites across seven countries.
The initial release of data from PROGRESS presented at the third International Brain Stimulation Conference in Vancouver (Canada) evaluated 66 patients at three months and found that the majority had a wider therapeutic window than patients who were using omnidirectional leads (89.4%; p<0.0001). Results showed that directional DBS with the Infinity system increased the therapeutic window by 35% and required 30% less energy to achieve therapeutic benefit. The study satisfied both the non-inferiority and superiority objectives for therapeutic window. The full study cohort will reach the three-month primary endpoint later this year.
“In the PROGRESS trial, patients were assessed sequentially, receiving conventional stimulation followed by directional stimulation. Despite being blinded to their stimulation type, twice as many patients preferred directional stimulation. Clinicians also preferred directional stimulation in four times as many patients, demonstrating that the Infinity system with our directional lead technology can help people find symptom relief more easily than systems with conventional stimulation,” said Keith Boettiger, vice president, Neuromodulation, Abbott. “This post-market study provides real-world evidence that the Infinity system is transforming the field of deep brain stimulation and helping patients battle debilitating movement disorders.”