Yesterday, the United States Food and Drug Administration approved a brain implant that helps fight Parkinson’s Disease and essential tremor. The device is called the Brio Neurostimulation System, and has been described by the FDA as “an implantable deep brain stimulation device” that’s there to “help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors” in a recent press release. Over fifty thousand Americans are diagnosed annually with Parkinson’s, and millions over the age of 40 suffer from essential tremor.
Parkinson’s still uncured, but now easier to live with.
Managing Parkinson’s Disease symptoms are now easier thanks to the system, and users should see an improvement in symptom manifestation. The brain stimulation device is made up of a small rechargeable battery, a pulse generator, and wire leads going from the pulse generator to brain locations that depend on the illness at hand. Those who have received training in the operation of the Brio Neurostimulation System can adjust the device for different effects as needed.
FDA approved brain implant based on results of two clinical trials.
Two trials were essential for the approval of the device by the FDA. One lasted for three months and had a sample size of 136 patients, while the other lasted six months and has 127 patients. The first group consisted of Parkinson’s patients, while the second was made up of people suffering from essential tremor. Both groups statistically showed significant improvement in the effectiveness of action when the device was turned on versus when it was turned off.
Brain implant is not without its risks, though.
The Brio Neurostimulation System has its share of side effects, some quite nasty. The major one is intracranial bleeding, which can lead to stroke paralysis, or death according to the FDA. There was actually a device with a similar goal on the market, Medtronic’s Activa Deep Brain Stimulation Therapy System, which was approved in 1997 for treatment of tremors associated with essential tremor and Parkinson’s disease. That device was also a brain implant, and the FDA widened the system’s indications in 2002 to include the symptoms of Parkinson’s disease.