The US Food and Drug Administration have given approval to an implantable brain stimulation device for reducing the symptoms of Parkinson's disease and essential tremor when medication alone is unable to provide adequate relief.
The Brio Neurostimulation System is the second device to be approved by the US Food and Drug Administration (FDA) for treating these disorders and can reduce symptoms such as balance problems, tremors and walking difficulties.
"There are no cures for Parkinson's disease or essential tremor, but finding better ways to manage symptoms is essential for patients," says Dr. William Maisel of the FDA. "This new device adds to the array of treatment options to help people living with Parkinson's and essential tremor enjoy better, more productive lives."
Around one million people in the US are believed to have Parkinson's disease, with an estimated 50,000 people newly diagnosed with the progressive nervous system disorder each year.
Parkinson's disease symptoms are caused by the degeneration of nerve cells that produce the neurotransmitter dopamine, a chemical that helps transmit messages from the brain related to the control and coordination of body movements.
The cause of essential tremor is currently unknown, but the condition leads to involuntary shaking - typically in the hands - that is similar to that caused by Parkinson's disease. The condition affects several million people in the US, mostly over the age of 40.
Drugs are frequently used to reduce tremors in people with Parkinson's disease and essential tremor, but sometimes medicine is unable to adequately alleviate disruptive symptoms. When this is the case, the new Brio Neurostimulation System could be of use.
A battery-powered generator that sends electrical pulses to the brain
Manufactured by St. Jude Medical in St. Paul, MN, the device consists of a small electrical pulse generator implanted under the skin of the upper chest. The generator is connected to electrodes positioned within the brain according to whether the device is being used to treat Parkinson's disease or essential tremor.
The battery-powered pulse generator is fully rechargeable and delivers low-intensity electrical pulses to these electrodes through wires. Health care providers can adjust the activity of the pulse generator in order to maximize the effects for the patients using the device.
Among the data presented to the FDA to demonstrate the safety and efficacy of the device were two clinical studies: one involving 136 participants with Parkinson's disease and one involving 127 patients with essential tremor.
In both studies, the participants were experiencing tremors that were not being adequately relieved by medication. After 3 months for the patient with Parkinson's disease and 6 months for the patients with essential tremor, the researchers assessed the effectiveness of the device.
For both groups of patients, significant improvement in symptoms was noted when the device was turned on compared with when the device was turned off. In the patients with Parkinson's disease, the device was used alongside medication while the majority of patients with essential tremor could manage their symptoms without additional drug therapy.
A number of adverse events related to use of the device were observed by researchers. These ranged from infection and dislocation of the device under the skin to more severe events such as intracranial bleeding. These events occurred infrequently enough, however, for the FDA approve the device.
Earlier this year, Medical News Today reported on a study finding that difficult Parkinson's symptoms such as swallowing dysfunction and freezing of gait respond were improved more with low-frequency deep brain stimulation compared with the more usual high-frequency brain stimulation.