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A new type of deep brain stimulation system, with independently controllable current for each of the device's eight electrodes, effectively reduced symptoms in patients with advanced, levodopa-responsive Parkinson's disease in a pivotal trial, researchers reported here.
The study of Boston Scientific's Vercise System, conducted by Jerrold L. Vitek, MD, PhD, of the University of Minnesota and colleagues, met its primary endpoint marked by a significant mean difference between the active and control groups in time spent in "on" time after 12 weeks without any increase in antiparkinsonian treatments (3.03 ± 4.2 hours from baseline, P<0.001).
Late-breaking findings from the multicenter, prospective INTREPID study, presented at the annual meeting of the American Academy of Neurology, also reported an over 49% improvement in motor symptoms with deep brain stimulation treatment compared to pre-surgical screening, measured with the Unified Parkinson's Disease Rating Scale III.
One year after treatment, the group also reported a 6-hour improvement in "on" time without troublesome dyskinesias, which was measured by a 3-day, patient-reported PD diary.
There was also notable benefit in quality of life for these patients, marked by an improvement in the Parkinson's Disease Questionnaire 39.
INTREPID was the principal study supporting the FDA's approval of Vercise in December 2017. The one-year findings of the study reflected 292 patients with Parkinson's disease assessed across 23 U.S. sites. All patients who were included in the study had stable use of Parkinson's medications over the prior month, as well as a 2 year history of resting tremor, rigidity or bradykinesia, as well as 6 hours of troubled motor functioning.
Deep brain stimulation was administered with the constant-current Vercise System, which was implanted in the subthalamic nucleus compared to a sham control group. The clinician then has the ability to independently control current levels administered through the eight electrodes, across a total span of 15.5 mm each with a 0.5-mm contact, attached to bilaterally implanted leads.
All patients received the device, but were randomized to receive stimulation intended to be therapeutic versus a low intermittent current dose not expected to be effective.
In the active treatment group, more than 40% of the stimulation delivered through the electrodes utilized fractionalized current over two or more of the contacts, Vitek said.
"This is the first-ever double-blind study" in Parkinson's disease, Vitek noted when highlighting the unique aspects of this study. The post-implant baseline measurement allowed assessment of the device's "microlesion" effect, which hadn't been done before, he added.
This device was recently FDA approved in December 2017 indicated for the treatment of Parkinson's disease symptoms, based on initial data from this study. The approval was also based on findings from the single-arm VANTAGE study released in 2015 with the 5-year outcomes published earlier this month, which reported positive results with the 16-contact Vercise system in patients with moderate-to-severe Parkinson's disease.
Notable, is the long battery life of the rechargeable Vercise System, lasting over 15 years, which also has the ability to adapt to individual needs in accordance with disease progression.
Overall, the safety profile was similar to previous studies of deep brain stimulation, Vitek mentioned. Infection was the most common adverse event, with an overall incidence of 2.7% across the cohort. Incidence of peri-operative intracranial hemorrhage was around 1%.
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