Healthcare Industry News: Neurostimulation
News Release - February 11, 2009
UT Southwestern Performs First Local Implant in Deep Brain Stimulation Study for DepressionDALLAS--(HSMN NewsFeed)--UT Southwestern Medical Center neurological surgeons have begun implanting patients as part of a clinical study that is investigating whether deep brain stimulation (DBS) therapy may help people who suffer from major depressive disorder, a severe form of depression.
The BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) study is a controlled, multi-site, blinded, clinical study that is evaluating the safety and effectiveness of DBS therapy in patients with depression for whom currently available treatments are not effective. UT Southwestern is one of three U.S. sites currently participating in this clinical study.
The Libra® DBS system being evaluated in this study is designed to provide mild pulses of current to a part of the brain called Brodmann Area 25. This area appears to be overactive when people are profoundly depressed.
“Studies such as this are an important step in the development of new therapies. Treatment-resistant patients are those who have tried numerous medications to treat their depression. They feel hopeless and over many years, their quality of life has deteriorated,” said Mustafa Husain, M.D., professor of psychiatry and internal medicine at UT Southwestern and director of the UT Southwestern Neurostimulation Research Lab. “We are optimistic that this research will lead to a therapy that can provide these patients with some much-needed hope.”
In the U.S., more than 21 million adults suffer from some kind of depressive disorder, according to the National Institute of Mental Health. Of these, only about 80 percent can be effectively treated with currently available therapies, according to the National Advisory Mental Health Council. That means approximately 4 million adult Americans live with depression that doesn’t respond to medications or psychotherapy.
“The Libra DBS system’s generator or ‘battery’ is implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain,” said Tony Whitworth, M.D., assistant professor of neurological surgery at UT Southwestern, who performed the implants. “The implantation surgery takes about two to three hours. Patients typically are able to go home one or two days after the procedure.”
The BROADEN study is sponsored by the Plano-based Neuromodulation Division of St. Jude Medical and is being conducted under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE).
For more information about this study, call toll-free 866-787-4332 or visit www.BROADENstudy.com. In the Dallas/Ft. Worth area, call 214-648-4622 or 214-648-2806.
Visit http://www.utsouthwestern.org/neurosciences to learn more about UT Southwestern’s clinical services in neurosciences.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
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Source: St. Jude Medical
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