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January 16, 2002


Bilateral Deep-Brain Stimulation Receives FDA Approval For Patients with Advanced Parkinson's Disease

The U.S. Food and Drug Administration (FDA) late yesterday approved a new form of treatment, using a so-called "brain pacemaker", for patients in the advanced stages of Parkinson's disease. In studies conducted at Emory University and 17 other locations, the treatment, known as bilateral deep-brain stimulation (DBS), has been shown to relieve slowness, stiffness and shaking that are associated with the debilitating disease. While the treatment moderates symptoms, it does not reverse the progression of the disease and is not a cure.

Also known as Activa® Parkinson's Control Therapy, the treatment involves surgical implantation of electrodes into specific areas of the brain. Those electrodes are connected to a pulse generator device, similar to a cardiac pacemaker, under the skin and near the collarbone.

"The DBS device delivers controlled electrical stimulation to regions of the brain involved in the development of the motor symptoms associated with Parkinson's disease," says Emory University neurologist Jerrold Vitek, M.D., Ph.D. "Those regions are the internal segment of the globus pallidus and the subthalamic nucleus."

Initial studies indicate that stimulating either of these two regions can reduce slowness, stiffness and tremor of Parkinson's disease, as well as drug-induced involuntary movements.

A recent multi-site, international study showed promising results in treating Parkinson's patients with bilateral DBS. Emory University was one of 18 sites involved in the study. From that study, data submitted to the FDA showed that Activaš

Parkinson's Control Therapy safely and effectively improved movement control and mobility in patients with advanced stages of the disease, when drugs alone proved inadequate. Dr. Vitek served as principal investigator of the study at Emory.

Not all Parkinson's patients need bilateral stimulation, however. "If patients only show tremor, slowness and stiffness on one side, then the unilateral implant is enough," Dr. Vitek points out. "But if patients show symptoms on both sides, then the bilateral stimulation is recommended."

In 1997, the FDA approved unilateral stimulation in the thalamus for the treatment of tremor, which consists of stimulating just one side of the brain. Now, with the approval of bilateral stimulation in the subthalamic nucleus and the internal segment of the globus pallidus to treat all the cardinal motor symptoms of Parkinson's disease, this good technique becomes even better, according to researchers.

The cause of Parkinson's is unknown, but the symptoms stem from the degeneration of neurons or brain cells that produce dopamine. Dopamine is a neurotransmitter that enables communication among the brain cells involved in motor control. Activa Therapy's electrical stimulation acts on these malfunctioning circuits of the brain.

Doctors say this "brain pacemaker," created by Medtronic, Inc., is so promising because once implanted, benefits can be optimized and side effects minimized by simply adjusting the stimulation. Patients can turn the device on and off with a hand-held magnet. If a side effect develops, the voltage can be lowered or other parameters of stimulation changed. And the therapy is reversible, meaning patients will be able to pursue new treatments that may be developed in the years ahead.

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