Monday, November 18, 2013

UK is first in U.S. to conduct clinical trial for new Parkinson's treatment that shows improvement in all five patients so far

A new treatment strategy for Parkinson's disease at the University of Kentucky could change the way the ailment is treated, manage symptoms better and halt or reverse the progressive degeneration of the brain that comes with the disease, the university announced Monday.

Dr. Craig van Horne demonstrated a deep-brain stimulation
remote control unit on Parkinson's patient Rodney Parsons.
(Lexington Herald-Leader photo by Charles Bertram)

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UK is the first U.S. university to conduct a clinical trial of the strategy, led by principal investigator Dr. Craig van Horne, associate professor of neurosurgery in the College of Medicine, according to a news release from the university.

Parkinson's, a progressive and degenerative disease, affects around 1 million Americans and 10 million people worldwide, according to the release. Symptoms include both motor and non-motor symptoms including tremor, rigidity, slow movement and unstable posture. No cure exists.

The first course of treatment is medication, but any medication loses its effectiveness over time.The second line of treatment is deep brain stimulation, a surgical procedure that works like a "brain pacemaker." Electrodes are surgically implanted into the malfunctioning part of the brain where cells have died to emit electrical impulses to regulate the brain's abnormal impulses, according to the release.

Deep brain stimulation has improved the quality of life for many people with Parkinson's, but while it manages symptoms, it does not change the course or outcome of the disease, according to the release. UK's clinical trial explores an additional treatment option, and possibly a way to alter the course of the disease.

"They are conducting an innovative clinical trial that builds upon the established deep brain stimulation procedure by supplementing it with a nerve graft of patients’ own peripheral nerves," the release says. "The nerves in the brain do not regenerate when they are damaged, but peripheral nerves—nerves outside of the brain and spinal cord—can regenerate." The trial will "aim to use the regenerative capacity of peripheral nerves to allow the brain to heal itself."

The procedure will implant a small piece of a patient's peripheral nerve from just above an ankle. This can be done at the same time as deep brain stimulation, so the patient will get the benefit from both procedures, the release says. The effect of the implant will be tested by simply turning off the deep brain stimulator. The hope is that the peripheral nerve will "stimulate regeneration in the parts of the brain that have been damaged by Parkinson's disease."

So far, five Parkinson’s patients have undergone the combined procedure. The trial calls for six. All five have shown consistent improvement in symptoms and "were able to entirely go off the medication one month later, relying on the deep brain stimulation device to manage their symptoms," the release says. Normally, deep-brain stimulation patients are able to reduce their medication but not eliminate it.

"The patients can have more consistent 'on' times—fewer ups and downs with their symptoms," Van Horne said. "They’re not fluctuating due to meds if they’re just using the stimulation."

The trial has progressed quickly because it uses the patient's own tissue, with no risk of rejection or need for immuno-suppressant drugs, and takes only 30 minutes longer than standard deep brain stimulation.  If successful, this procedure could significantly change the treatment of Parkinson’s disease, the release says, and could have an impact on other neuro-degenerative disorders. To learn more click here.

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