LEXINGTON — Researchers at the University of Kentucky are set to begin an innovative clinical trial of a device they believe can reverse the degenerative neurological effects of Parkinson's disease.

        The device is an implantable pump that delivers a naturally occurring protein, which helps grow dopamine neurons in the brain, by catheter directly into the part of the brain that is damaged by Parkinson's.

        Current treatments focus only on improving the symptoms of the illness but do nothing to actually restore function to the parts of the brain ravaged by the disease, Greg Gerhardt, director of the school's Morris K. Udall Parkinson's Disease Research Center of Excellence, said during a news conference Monday to announce the trial.

        Parkinson's disease is a neurological condition most often seen in older people that progressively destroys brain cells and impairs control of body movement and speech.

        Symptoms of the disease include tremors, stiff limbs, slow or absent movement, a lack of facial expressions a shuffling gait, stooped posture, depression and, in some cases, an impaired ability to think.

        According to the National Institute of Neurological Disorders and Stroke, Parkinson's disease affects more than 500,000 and as many as 1 million Americans. It is estimated that 20,000 Kentuckians have the disease.

        The protein being used in the study is called Gail cell line-derived neurotrophic factor (GDNF).

        “GDNF is a very important compound in our world,” Mr. Gerhardt said. “In animal models, we've shown that the direct infusion of GDNF into the section of the brain affected by Parkinson's can actually restore function to brain cells that are damaged or dying.”

        The study is a Phase I clinical research trial, meaning that researchers primarily will be investigating the safety of the device on participants.

        Researchers will be looking for 10 subjects who will have the device implanted and then studied for side effects or any other irregularities.

        “The patients will be studied for about nine months after the pump and catheter are implanted,” said Dr. John Slevin, a professor in the UK College of Medicine's Department of Neurology.

        “Once we prove that it is safe, we will expand the study to look more closely at its efficacy, how it actually works.”

        GDNF is found naturally in the human brain but tends to decrease as a person ages. It is believed that the destruction of dopamine neurons, which are aided in growth by the protein, causes the symptoms of Parkinson's disease.

        Laboratory studies have shown that GDNF both protects and promotes regeneration of injured dopamine neurons and may directly influence the degenerative disease process.

        “Basically, what we're trying to do is improve, or even restore, normal circuitry in the brain that has been cut off by Parkinson's,” said Don Gash, a professor in the college's Department of Anatomy and Neurobiology.

        “We've seen very profound improvements in motor function of animals who had shown symptoms of late-stage Parkinson's. We have actually seen that injured neurons that have shrunk grow back to normal size range when treated with GDNF.”

        The battery-powered pump, about the size of a small yo-yo and refillable, is implanted into the abdomen of the patient with a tiny tube connecting it with a small catheter in the brain.

        The pump's programmable computer precisely regulates the flow of a four-week supply of GDNF directly into the brain via the catheter.

        The pump currently is approved for delivery of drugs directly to the fluid around the spinal cord in patients with some conditions and the delivery of chemotherapy agents to treat colorectal cancer that has spread to the liver.

        The Udall Parkinson's Research Center is one of only 11 such centers in the nation.

        The foundation for the new investigational treatment came from basic research done by Gerhardt and Gash at the center, and the trial is being funded by a $5 million grant from the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health.

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