St Jude Medical's first controlled study on deep brain stimulation (DBS) confirms the benefits of a constant current system for patients with Parkinson's disease (PD).
The Libra and LibraXP systems incorporate a neurostimulator, a surgically implanted battery-operated device that generates mild electrical pulses and carries these pulses to a targeted area in the brain via leads.
The study enrolled 136 patients that, on average, had suffered from PD for at least five years, had moderate to severe dyskinesia, and experienced six or more hours a day of diminished motor symptom control. The aim was to determine the efficacy of Libra and LibraXP DBS constant current systems in managing the symptoms of PD.
In the study, patients receiving stimulation had a 73% response rate compared with a 38% response rate in the group without stimulation, and motor scores for those in the stimulation group improved 39% compared with the baseline as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).
The primary endpoint of the study was defined as an increase in the duration of 'on time' without bothersome dyskinesia when measured after three months. The study demonstrated that participants in the stimulation group averaged an increase of 4.27 hours of 'on time', compared with an increase of 1.77 hours in the group without stimulation.
National Parkinson Foundation national medical director Michael Okun said this data epresents a new approach to deep brain stimulation treatment and provides new evidence supporting the positive benefits DBS therapy can provide patients. "These results are important as they represent the first large, randomised, controlled study of a constant current device for managing the symptoms of Parkinson's disease," Okun said.
St Jude Medical Neuromodulation Division president Rohan Hoare said the results confirm the benefit of the constant current deep brain stimulation device platform and lay the foundation for future therapy innovation.
Currently, Libra and LibraXP neurostimulators are approved for use in managing the symptoms of PD throughout Europe, Latin America and Australia.