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News in Brief
FDA Approves Two New Devices for Deep Brain Stimulation
The U.S. Food and Drug Administration (FDA) has recently approved two new devices that will improve the efficiency of the surgical technique known as deep brain stimulation (DBS). Both products are manufactured by Medtronic Inc., the pioneer of Activa® Therapy, the DBS technique that treats Parkinson's symptoms by delivering an electrical current directly to selected brain cells.
One of the two - the Kinetra® Neurostimulator - uses a single device that is implanted in the chest like a pacemaker to carry an electrical impulse to both sides of the brain and help control Parkinson's symptoms. (The original Activa system used two such devices.) The improved version requires fewer surgical incisions and will possibly reduce the time needed to conduct the procedure.
The other device - Access® Therapy Controller - introduces a hand-held "remote control-like" programmer to enable patients to deactivate or reactivate their deep brain stimulation, to adjust the level of stimulation and monitor battery life while at home. This can lead to more effective therapy and less frequent battery changes.
Most doctors see surgical treatment for Parkinson's as an appropriate option for patients with intractable tremor, wearing off episodes or medication-induced dyskinesias. Any patient considering surgery should discuss this option thoroughly with his or her neurologist.
Rotigotine CDS: A Promising Source of Relief from Dyskinesias
The rotigotine CDS ("continuous delivery system"), a novel dopamine agonist formulated in a convenient once-a-day skin patch, significantly reduced motor symptoms and dyskinesia in a study of 242 Parkinson's patients published in the December 2003 edition of Archives of Neurology. Schwarz Pharma Inc. the study's sponsor, expects to announce the final results of the Phase III clinical trials in the summer of 2004.
The patch, which is applied to the abdomen, releases a steady dose of the drug using the skin as a delivery mechanism. This helps to increase efficacy and results in a lower incidence of fluctuations and side effects than are experienced with oral medication.
Reported side-effects include a sudden loss of consciousness that was experienced by two patients and an increase in the sudden onset of sleep while driving. More commonly reported side-effects were nausea, vomiting, fatigue and application site reactions.
According to an article recently published in Nature magazine, as many as ten percent of male patients diagnosed with atypical Parkinson's disease may actually be suffereing with a recently discovered genetic disorder known as fragile X-associated tremor/ataxia syndrome or FXTAS (pronounced fax-tass).
The disorder strikes about one in 3,000 men over the age of fifty and results in tremors, balance problems and dementia that become increasingly more severe with age. According to Dr. Paul Hagerman and his colleagues at the University of California, Davis, authors of the article, the disorder is caused by a small mutation in a brain-growth gene called FMR1, which sits on the X chromosome and causes a section of the gene to repeat itself. Women have two X chromosomes whereas men have one X and one Y. If there is a mutation on one X chromosome in a woman the chances are very high that the other X will be healthy, precluding the occurrence of FXTAS.
Screening for the gene mutation in men who have tremor and balance problems is important regardless of their family history, especially when accompanied by other signs such as rigidity, short-term memory loss and or dementia.
While FXTAS as yet cannot be prevented or treated, knowing the correct diagnosis could forestall inappropriate medications and surgical procedures. As scientists learn more about FXTAS, it may provide insight into the mechanism and treatment of tremors and imbalance.