The first US implants of a novel deep brain stimulation system in research that is investigating the brain’s response to the therapy has been announced by Medtronic.
The Activa PC+S system delivers deep brain stimulation therapy while simultaneously sensing and recording electrical signals in key areas of the brain, using sensing technology and an adjustable stimulation algorithm.
The first two implants of the Activa PC+S system in the USA took place at Stanford Hospital and Clinics and the UC San Francisco (UCSF) Medical Center, USA, in patients with advanced Parkinson’s disease. Research teams led by neurologist Helen Bronte-Stewart, director of the Stanford Movement Disorders Center and professor of neurology and neurological sciences at the Stanford University School of Medicine, and neurosurgeon Philip Starr, professor of neurological surgery and surgical director of UCSF’s Bachmann-Strauss Dystonia and Parkinson Foundation Center of Excellence, are the first in the USA to use the Activa PC+S system.
The teams will analyse the data with the aim of understanding how the brain responds to deep brain stimulation therapy. At Stanford, the system was implanted by neurosurgeon Jaimie Henderson, associate professor of neurosurgery at the Stanford School of Medicine. At UCSF, the system was implanted by Starr, with patient recruitment and preoperative evaluation led by Jill Ostrem, professor of neurology and medical director of UCSF’s Bachmann-Strauss Center, and Marta San Luciano, assistant professor of neurology.
“While deep brain stimulation therapy is widely proven to treat symptoms of advanced Parkinson’s disease and other movement disorders, the ability to collect and analyse data demonstrating how the brain responds to this therapy was not possible until now,” says Starr, whose early research studies and collaboration with Medtronic helped lead to first human uses of the Activa PC+S system. “At UCSF we are leveraging the broad capabilities of this new device by implanting recording electrodes in the deep-brain structures that have traditionally been targeted by deep brain stimulation and also in crucial areas of the cerebral cortex. This may help give us a better understanding of how Parkinson’s disease and other devastating conditions progress in the brain.”
“We hope that discoveries facilitated by this deep brain stimulation system will fuel the development of new treatments for a range of disorders,” said Bronte-Stewart. “With the new deep brain stimulation system we will be able to record the brain’s signalling patterns at the same time that we are measuring the patient’s movements, with the goal of understanding which brain signals correspond to which specific patterns of movement in that patient.”
The first US implants follow the first worldwide implant of the Activa PC+S system at Ludwig Maximilian University in Munich, Germany in August 2013, and the first implant in a patient with essential tremor in November 2013 at University Hospital of Würzburg in Germany. The new system is being made available to a select group of worldwide researchers who will use the system to conduct clinical studies with the goal of understanding the brain’s response to deep brain stimulation therapy.
The Activa PC+S system received CE mark approval in January 2013 and is being made available in Europe for research use with select physicians. This system, which is not approved by the FDA for commercial use in the USA, is only available to select physicians for investigational use.