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U.S. clinical trial begun for treatment of Parkinson’s Disease

Posted: October 18, 2013 2:00 a.m.
Updated: October 18, 2013 2:00 a.m.

Boston Scientific launches a clinical trial in the United States to treat Parkinson's disease. Above, an employee manufactures the company's rechargeable spinal cord stimulator at it's Valencia office.

 

Boston Scientific is conducting clinical trials in the United States for a system that improves motor function in people who have Parkinson’s Disease.

The biomedical company’s deep brain stimulation device and system – Vercise DBS - has already been approved overseas in Europe, Israel and Australia.

“We started a clinical trial in the United States,” said Maulik Nanavaty, PhD and president of the Neuromodulation business unit at Santa Clarita’s Boston Scientific. “The first patient began at Cedars-Sinai in July.”

While there is no known cure for Parkinson’s, medical scientists do know the disease is tied to a reduced number of cells in the brain that produce dopamine.

The brain chemical dopamine helps control muscle movement. Parkinson’s occurs when the nerve cells in the brain that make dopamine are slowly destroyed, according to the National Library of Medicine. Without dopamine, the nerve cells in the brain cannot properly send messages leading to loss of muscle function.

“Dopamine is a chemical stimulation,” Nanavaty said. “The DBS system provides an alternative. It’s a very precise form of targeted electrical stimulation.”

The DBS system treats the symptoms, said Deanna Harshbarger, global director of DBS for Boston Scientific. “More research has to be done as to whether it slows the progression of the disease - which is degenerative.”

Currently, the standard treatment for Parkinson’s in the U.S. is medication.

“Medication works wonderfully in early Parkinson’s patients. But, beyond a certain point the body starts to develop a tolerance,” Nanavaty said. “There’s an ebb and flow that gets worse and worse because it’s a degenerative disease.”

When the body builds a tolerance to the medicine and its effectiveness begins to wear off, side effects become more pronounced such as an increase in tremors. And people start having side effects from the drug. They have to wait for the medication to begin working again.

The difference in treatments is that with the DBS system, even though the patient remains on medications albeit with reduced doses, the system delivers electrical stimulation to the brain offsetting the reliance solely upon medication.

With the DBS system, eight lead wire contacts are implanted in the brain and connected to a medical device. The lead wires can be individually powered up or down to selectively stimulate areas within the brain. The device can continue to calibrate stimulation as body is needed, Nanavaty said. And it provides physicians with a fine level of control over the stimulation.

“Think about the size of a pea,” he said. “We can target one side of that pea so we don’t stimulate other parts of the brain and so you don’t have side effects elsewhere.”

Or, think of a floor lamp with four lights, Harshbarger said. A person turns off one light or more. Boston Scientific’s device is like a dimmer switch that goes up and down to put the right amount of light precisely where it’s needed, she said.

“You don’t need all that medication that you were given before,” Nanavaty said. “With the electrical stimulation you can cut the medications in half and the ‘on times’ (when the medication is working) becomes longer. You are able to function normally for a much longer period of time.”

Overseas trials showed a significant improvement in motor function and daily living activities, as well as an improved overall quality of life at six months, the company reported.

“The results we saw from the European studies showed very significant improvement for the patients. The results were positively surprising for us,” Nanavaty said. “There was more than a 62 percent improvement on the UPDRS scale (Unified Parkinson's Disease Rating Scale). What was interesting is that results showed a level of higher improvement that you normally have not seen. This has given us a leading indication that this is a therapy that may be a ground breaking therapy.”

There are many other diseases that are more neurological in nature – like Alzheimer's - and research in the field really just began 10 years ago. Researchers are on the future frontier of brain research, he said.

But there is also an increasing amount of research to identify how to stimulate other parts of the brain. An “Obama initiative” and the European Union is looking at depression and people feel there’s an opportunity for patients with severe depression to be treated in other ways, Nanavaty said.

“We believe that this is just the beginning. We are looking at all the different areas and doing some early work,” he said. “It’s exciting for us. We’re making a difference in peoples’ lives.”

This story published in the Santa Clarita Valley Business Journal which can be viewed at www.signalscv.com/scvbj/.

 

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