FDA Approves New Treatment for Parkinson’s Disease and Essential Tremor

The FDA announced in June that it has approved the Brio Neurostimulation System, a deep brain stimulation device that is implanted under the skin of the upper chest with electrodes attaching to certain regions of the brain, to mitigate symptoms of Parkinson’s disease (PD) or essential tremor—another prominent movement disorder that causes tremors. The device is powered by a small rechargeable battery and sends low-intensity electrical pulses to targeted areas in the brain, depending on whether it is being used to treat PD or essential tremor.

An estimated 50,000 Americans are diagnosed with PD each year, according to the National Institutes of Health, and ~1 million Americans already have the condition. The disorder is most commonly found in adults aged 65 and older and occurs when dopamine-producing cells in the brain are depleted, causing motor function impairments that hinder the ability to perform everyday tasks such as eating, writing, and shaving.

Essential tremor occurs in several million people and causes similar symptoms to PD. It normally affects only the hands and arms; however, similar to PD, it can progress to the rest of the body over time, eventually affecting the voice, tongue, and legs. Researchers have thus far been unsuccessful in pinpointing the causes of essential tremor, but a few gene mutations are believed to contribute to its onset.¹

The implant was studied in two clinical trials, one with PD patients and one with essential tremor patients. Each trial included more than 100 patients, all of whom had symptoms that were not adequately controlled with drug therapy. In both trials, patients showed statistically significant improvement when the device was turned on. However, some adverse events were noted, including intracranial bleeding, infection, and dislocation of the device under the skin (https://1.usa.gov/1Bc5ptq).

The Brio Nurostimulation System provides an important addition to the currently available treatments for patients with PD or essential tremor. William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, says that, despite the lack of a cure for these conditions, “finding better ways to manage symptoms is essential for patients.” — Sean McGuire

Reference:

1.     H Deng, W Le, J Jankovic. Genetics of essential tremor. Brain. 2007;130:1456-1464.