FDA approves new DBS device / "DBS-3" (June 2015)












FDA Approves New Deep Brain Stimulation Device

Posted by  Maggie McGuire, June 16, 2015


The Brio Neurostimulation System consists of a pacemaker-like device implanted in the chest and electrodes in the brain. Image via St. Jude Medical


The U.S. Food and Drug Administration (FDA) announced Friday that it had approved another deep brain stimulation (DBS) device for treatment of Parkinson’s disease and essential tremor.


The Brio Neurostimulation System from St. Jude Medical works in a similar way as the available DBS device: Medtronic’s Activa Deep Brain Stimulation Therapy System, approved in 1997 for tremor and in 2002 for Parkinson’s disease.


In DBS, a neurosurgeon implants a thin electrode into the brain, targeting motor and potentially other circuits that are not functioning properly. Small electrical pulses from a device similar to a cardiac pacemaker modulate the signals that cause some motor symptoms. While a powerful treatment for many people living with Parkinson’s, this therapy does not treat all symptoms and isn’t suitable for all patients.


Of the new Brio Neurostimulation System, the FDA wrote in a press release, “Data supporting the safety and effectiveness of the device system included two clinical studies.


One study included 136 patients with Parkinson’s disease and the other included 127 patients with essential tremor. In both studies, patients had symptoms, including tremors, that were not adequately controlled with drug therapy.”


“More options is always good news for patients,” said MJFF CEO Todd Sherer, PhD. “But we are not finished. MJFF is supporting studies to improve and expand the experience of deep brain stimulation for people with Parkinson’s.”


MJFF funds studies into next-generation DBS that would send electrical stimulation only when brain function requires, not continuously as devices do now. Such an advance would extend battery life (lengthening time between replacement procedures) and perhaps help avoid side effects such as nausea and expand the availability of DBS to patients not currently referred for the procedure due to confounding factors.

Foundation-funded researchers are also exploring DBS in a new area of the brain to ease postural instability and gait difficulties, a symptom difficult to treat.

Watch a webinar on deep brain stimulation and the wave of research in this area.






Improving Deep Brain Stimulation to Treat Freezing of Gait


Posted by  Maggie McGuire, October 06, 2014






While deep brain stimulation (DBS) is a powerful treatment for many people living with Parkinson’s, this therapy does not treat all the symptoms of PD and isn’t suitable for all patients. Earlier this year we launched a funding program to support projects that seek to improve DBS or to explore other neuromodulation techniques.


In DBS, a neurosurgeon implants a thin electrode into the brain, targeting motor and potentially other circuits that are not functioning properly. Small electrical pulses from a device similar to a cardiac pacemaker modulate the signals that cause some Parkinson's motor symptoms.


Dr. Michael S. Okun, co-director and professor of the Center for Movement Disorders and Neurorestoration at the University of Florida College of Medicine and national medical director for the National Parkinson Foundation, is the recipient of an MJFF grant to improve upon the current standards and to help more people with DBS therapy.

His project targets freezing of gait and uses an advanced approach, sending electrical impulses only when the brain needs them. Current DBS sends pulses continuously, which may result in side effects, may not adequately address freezing of gait and may burn the device’s battery at a rapid clip.


Dr. Okun spoke with us about his research:


MJFF: Does current DBS treat freezing of gait?


Dr. Michael Okun: People with gait disturbances frequently report inconsistent responses, no response and sometimes even worsening of freezing following DBS. The current technology works for people with Parkinson’s who have a good response to dopaminergic medications; DBS is very good at addressing tremor, “on/off” fluctuations and dyskinesia. Walking and balance dysfunction and freezing can be very disruptive for patients, and can lead to falls and injury, but the response to DBS has been disappointing. Gait can sometimes improve, especially if “on” time is enhanced by DBS; however gait and balance problems and freezing all tend to progress and become resistant to medications and to DBS.


MJFF: What is the aim of your project?


MO: We’re looking at a novel way to detect brain signals responsible for freezing and to modulate them with a technology we believe may be capable of breaking the freezing episodes.

We’re going to place DBS leads into parts of the brain called the globus pallidus interna (GPi) — a frequent target of DBS for Parkinson’s — and the pedunculopontine nucleus (PPN), which is a well-known locomotor center that has important connections relevant to walking.

We’re not putting in regular DBS devices. The technology we will use will allow us to measure something called local field potentials, where we can monitor, in real time, the electrical currents from both the GPi and the PPN, and more importantly sample the conversations going on between these regions. We believe there’s a network of activity that underpins gait dysfunction in Parkinson’s disease. In this project we are going to begin to get a picture of what the “brain freezing” network looks like.


MJFF: How will that help you develop a new kind of DBS?


MO: For the first several months after implantation we’re going to monitor and learn about these brain signals. In a controlled laboratory setting, we can set the device for closed-loop stimulation, meaning it only fires an electric impulse when the device sees the “freezing signal” in the brain. We think the GPi may be the gas pedal and the PPN may be the brake. So if someone freezes, we may need to take our foot off the gas and de-activate the brake. We’re going to explore different DBS stimulation paradigms to understand the signals, and then to modulate them and try to gain control of freezing symptoms.


MJFF: Why is closed-loop stimulation advantageous?


MO: No two people with Parkinson’s disease are alike. We need to understand what network signals change during individual symptoms, and then we need to deliver an efficient therapy “on demand” that will be appropriate for a particular symptom. We are entering the era of personalized medicine for Parkinson’s disease.

Freezing of gait is one disabling symptom of Parkinson’s disease, and we are hoping that the brain signals will reveal that it is a straightforward problem. If we can demonstrate that the application of these technologies works for freezing, perhaps we can take another step toward some of the more complex issues.


MJFF: How has MJFF played a role in your research?


MO: The partnership has been terrific. The Michael J. Fox Foundation understands the innovation that needs to happen to bring us cutting-edge technologies. We believe we have a very good idea and a lot of reason to believe we can make it work in people with PD. This is where MJFF has done a great job in allowing researchers like us to take a step closer to our dream, which in this case is a personalized approach to treating Parkinson’s disease.


Learn more about other research into closed-loop DBS.


Read more from Dr. Okun in his book on Parkinson’s treatment.