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Wednesday, Jan. 18, 2006

Health

Pitt develops wireless version of nerve stimulator

Wednesday, January 18, 2006

By Joe Fahy, Pittsburgh Post-Gazette

With help from local high school science teachers, University of Pittsburgh researchers have developed a wireless device that they hope will be safer and less invasive than an existing vagus nerve stimulator.

The new device, a radio-frequency-powered neural stimulator, would allow patients to wear a two-inch device containing the stimulator's battery outside the body, clipped under a shirt collar.

Like the vagus nerve stimulator developed by Cyberonics Inc., the new device would require an incision in the neck to implant electrodes around the vagus nerve.

Unlike the Cyberonics stimulator, the new device would not require a second incision in the chest to implant a pulse generator containing the battery, or tunneling under the skin to thread a wire from the generator to electrodes placed on the vagus nerve. Its use thus could reduce the risk of infection or other surgical complications and would eliminate the need for surgery to replace the battery.

Some companies have shown interest in licensing the technology, said Marlin Mickle, professor of electrical and computer engineering at Pitt. It would be up to the company to further develop it and seek Food and Drug Administration approval.

The wireless stimulator was adapted from an earlier device developed by Dr. Mickle that uses radio-frequency technology for deep-brain stimulation of patients with Parkinson's disease. Michael Lovell, an associate professor of industrial and mechanical engineering, graduate student Steven Hackworth and Dr. Robert Sclabassi, professor of neurological surgery, also were involved.

Last summer, four science teachers from Allderdice, Peabody, Perry and Westinghouse high schools -- Theodora Bennett, Robert Cuda, Kathy Hoelzle and Eric Laurenson -- began working at Pitt under a program funded by the National Science Foundation, helping to convert the device for use in treating seizures.

During that process, the FDA approved the Cyberonics device for treatment of depression, and Pitt researchers believe their device also could be used for that purpose.

http://www.post-gazette.com/pg/06018/639501.stm


University of Pittsburgh |
News From Pitt
January 19, 2006

Contact: Karen Hoffmann
412-624-4356
klh52@pitt.ed

Pitt Researchers Develop Less Risky Treatment
Ffor Depression, Seizures

City high school science teachers help through NSF-funded program

PITTSBURGH-Researchers from the University of Pittsburgh, with the help of a team of Pittsburgh high school science teachers, have developed a wireless device that is implanted in the neck to fight depression and epileptic seizures. The U.S. Food and Drug Administration already has approved a wired version of the device, but that one carries risks and several undesirable side effects.

It has been known for several years that stimulating the vagus nerve, which connects the brain to several major organs, can offset drug-resistant epileptic seizures. Last summer, the FDA approved vagus nerve stimulation (VNS) for use to treat severe depression as well. The only current manufacturer of a VNS device is Cyberonics Inc. of Houston. In the company's product, a pulse generator is surgically implanted into the left side of the chest, and a wire extends from the device up through the left side of the neck to wrap around the nerve. Patients must undergo additional surgery to change the battery every three to eight years. The device can be turned off at any time with a magnetic wand.

VNS has few of the side effects of traditional treatments for depression: no sexual dysfunction or memory impairment and minimal sleep disturbance and weight gain, which are often associated with antidepressants or shock therapy. However, there is a risk of infection due to the surgical incisions, and the long wire lead may cause painful adhesions and restricted movement. Additionally, side effects include hoarseness, shortness of breath, and voice alteration, although these are alleviated when the device is turned off.

Last summer, eight teachers from City of Pittsburgh high schools came to Pitt under a National Science Foundation-funded program in which they divided their time between Pitt's Learning Research and Development Center and a research project of their choosing. Four of the teachers chose to work on a device to prevent seizures under the guidance of Marlin Mickle, Nickolas A. DeCecco Professor of Electrical and Computer Engineering at Pitt, and director of the University's Radio Frequency Identification Center for Excellence and John A. Swanson Institute for Technical Excellence; Michael Lovell, associate professor of industrial and mechanical engineering and associate dean for research in Pitt's School of Engineering, and director of the school's John A. Swanson Institute for Technical Excellence; Robert Sclabassi, professor of neurological surgery, neuroscience, psychiatry, electrical and mechanical engineering, and bioengineering and director of UPMC's Center for Clinical Neurophysiology; and Pitt electrical engineering graduate student Steven Hackworth.

The group hoped to treat seizures by modifying a method for deep-brain stimulation (DBS), which Mickle, and Lovell, and Hackworth had developed, that uses radio frequency technology to help treat diseases such as Parkinson's. The major technical challenge they had to overcome was to convert the voltage source required for DBS to the current source required for the seizure treatment.

The solution they developed is the Radio Frequency-powered Neural Stimulator (RFNS). The RFNS is made up of a receiving device implanted under the skin of the neck and a powering device placed above near the skin at the same site, under a collaran adhesive patch. Because this requires only one surgical incision, rather than the two required by VNS, the risk of infection is reduced. Other advantages of RFNS over the existing VNS system include no invasive tunneling from the shoulder to the neck region and an external battery, which reduces the need for subsequent surgeries and further lowers the risk of infection; and a short wire lead, reducing the chance of adhesions.

The next step for the researchers is to license the technology to a company, which would then need to obtain FDA approval.

###
1/19/06/tmw

http://www.umc.pitt.edu:591/m/FMPro?-db=ma&-lay=a&-format=d.html&id=2289&-Find


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By MARQUELLE MATTHEWS
For The Pitt News
January 30, 2006

Grades. Money. Life away from home. Social life. Sexual identity. Career choices.

These are just some causes of depression for college students, and according to a 2005 survey by the American College Health Association, more than 40 percent of students reported they felt “so depressed it was difficult to function” at least one time last year.

Common symptoms of depression include chronic stress, low self-esteem, hormonal imbalances, feelings of helplessness or hopelessness and negative thought patterns.

Depression can last weeks, months or even years.

But now, university researchers — in collaboration with a team of high school teachers — have developed a new treatment that could help combat depression.

The treatment, Radio Frequency-powered Neural Stimulator, is a wireless device designed to treat patients suffering from severe and treatment-resistant depression. Patients labeled “treatment-resistant” do not respond to pills, talk or shock therapy.

The wireless device would require electrodes to be surgically implanted around the vagus nerve in the neck. The vagus nerve connects the brain to several major organs in the neck, thorax and abdomen.

The Food and Drug Administration has approved a wired version of the device — called vagus nerve stimulation (VNS). The device is inserted in the chest and the wire winds up the left side of the neck and wraps around the nerve.

Adverse side effects of VNS include hoarseness, coughing, discomfort, difficulty swallowing and possible nerve damage. However, patients taking anti-depressants and undergoing shock therapy to treat depression run the risk of memory impairment, difficulty sleeping, weight gain and sexual dysfunction.

VNS patients undergo surgery to insert a battery, and every three to eight years additional surgery is needed to change it. Unlike VNS, the wireless device does not require a second surgery for a battery; it would be worn on the collar instead.

Marlin Mickle, professor of electrical and computer engineering at Pitt, said this fact alone makes the wireless device more convenient and safer.

“The less material put in the patient, the less risk of infection,” Mickle said.

Other University researchers who worked on the project include associate professor of industrial and mechanical engineering Michael Lovell, professor of neurological surgery Robert Sclabassi and graduate student Steven Hackworth.

The team of high school teachers participated in the project through the National Science Foundation’s Research Experiences for Teachers program, which aims to collaborate K-12 teachers and college faculty in engineering research in order to bring technical innovation in the classroom.

The wireless device was not developed from scratch. Researchers used the deep brain stimulator used to treat Parkinson’s Disease. The stimulator was developed by Hackworth in his master’s program.

Hackworth said it would’ve been like “reinventing the wheel in one summer” if they would’ve attempted to start from nothing.

Marlin said that he is confident the FDA will approve the wireless device.

Some companies have already shown interest in licensing the treatment, according to Mickle.



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New treatment for depression refined
Posted 01/30/2006

http://www.pittnews.com/vnews/display.v/ART/2006/01/30/43dd93cf75c34

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