Brain implant against parkinsonism and tremor
On June 12, the US Food and Drug Administration (FDA) approved the clinical use of the Brio Neurostimulation System, an implant for stimulating deep brain tissues in order to alleviate the symptoms of Parkinson's disease and essential (idiopathic) tremor. Brio Neurostimulation System can help some patients in cases where drug therapy does not provide sufficient relief of symptoms, such as difficulty walking, balance disorders and tremors.Parkinson's disease is one of the most common age-related neurodegenerative diseases. It usually develops over the age of 60 as a result of damage or death of nerve cells producing the neurotransmitter dopamine. Dopamine is necessary for the transmission of nerve impulses between regions of the brain that provide smooth directional movements, including the ability to eat, write and shave.
Idiopathic tremor is a motor disorder that usually develops after the age of 40 and is the most common cause of limb trembling. Both Parkinson's disease and idiopathic tremor are currently incurable, all existing therapies are symptomatic, but the search for more effective approaches to alleviate the symptoms of these diseases is a task of exceptional importance.
The Brio Neurostimulation System consists of a small (48 X 53 X 1 mm) battery-powered electrical pulse generator implanted under the skin of the upper chest, and wires leading to electrodes implanted in certain regions of the brain, selected depending on the disease. The generator continuously emits weak electrical pulses, the power and frequency of which are infused to optimize the effects provided by the device.The safety and effectiveness of the device has been confirmed by the results of two clinical studies. One of them involved 136 patients with Parkinson's disease, and the other involved 127 patients with idiopathic tremor. Participants in both studies had symptoms, including tremor, that could not be adequately controlled with medication.
The researchers implanted the Brio Neurostimulation System into the brains of all participants and evaluated the effectiveness of its action in Parkinson's disease for three months and in idiopathic tremor for six months. Both groups demonstrated statistically significant improvements in the assessed symptoms when the device is running compared to the state when it is turned off. At the same time, patients with Parkinson's disease continued to take medications, while the Brio Neurostimulation System allowed most patients with idiopathic tremor to control symptoms without medication.Reported adverse side effects included intracranial bleeding, potentially leading to stroke, paralysis, or death. There were also cases of infection and displacement of wires implanted under the skin.
The Brio Neurostimulation System, manufactured by St. Jude Medical, is the second device approved by the FDA for clinical use in Parkinson's disease. The first such device, Activa Deep Brain System Stimulation Therapy, developed by Medtronic, was approved in 1997 for the treatment of tremor in idiopathic tremor and Parkinson's disease, and in 2002 its scope of application was expanded to other symptoms of Parkinson's disease.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of The U.S. Food and Drug Administration: FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms.
17.06.2015