It's a pioneering treatment being tried for tinnitus as well as major depression in people who repeatedly have failed conventional therapies. Researchers at the Medical College of Wisconsin now have tried the surgery on a handful of tinnitus and depression patients. The treatments seem to be showing some early signs of benefit, even though doctors don't fully understand how they work.

The surgery involves removing part of the skull and placing electrodes on the cerebral cortex and then tunneling under skin and running a wire down to an electrical generator that is implanted under the collarbone.

For some reason, electrically stimulating the surface of the brain can dramatically reduce the sounds heard by people with tinnitus. And when the electrodes are implanted at a different spot on the cerebral cortex, the treatment appears to lessen the severity of symptoms in people with major depression.
Scientists say that electrically stimulating various locations on the cortex could prove to be therapeutic for a variety of brain disorders.

Clinical trials of the technology are being conducted or planned for major depression, epilepsy, stroke, chronic pain, obsessive compulsive disorder and tinnitus.

"People jump out of windows with bad tinnitus," said Eric Wassermann, chief of the brain stimulation unit at the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

Planting electrodes on the surface of the cortex builds on the success of a related treatment known as deep brain stimulation, Wassermann said. Deep brain stimulation has shown effectiveness in treating Parkinson's disease and other movement disorders as well as early success in depression and obsessive compulsive disorder. But deep brain stimulation is a more invasive surgery that requires inserting long, thin electrodes down into the brain.

Stimulating just the outer cortex with surface electrodes poses less risk of bleeding and infection, he said.

"Nothing goes into the brain," he said. "It's a much easier procedure for a surgeon to do."

In the next five to 10 years, hundreds of thousands of Americans with various intractable neurological ailments may be walking around with electrodes on their brains, said Ashwini Sharan, director of functional neurosurgery at Thomas Jefferson University.

"This is the tip of the iceberg," he said.

Others point to the paucity of large, rigorous studies of the therapy and the dubious history of psychiatric surgery. They question how many people ultimately will benefit from the treatment.

"It's promising, but the question is, how well does it work?" said Jason Schwalb, an assistant professor of neurosurgery at the University of Rochester. "How many people have diseases that are severe enough that they would submit to brain surgery?"

However it unfolds, doctors at the Medical College and Froedtert are at the center of the emerging field.

In two small clinical trials, they have implanted electrodes on the brains of 12 people, eight with severe tinnitus and four with major depression. As part of the same trial, researchers at two other universities have implanted electrodes in eight other people who have depression.

Brian Kopell, the Medical College neurosurgeon who implanted the devices in all of the tinnitus patients and four of the depression patients, said the initial results are promising in both groups of patients.

Among the eight tinnitus patients, there was significant improvement in at least four, he said. Among the 11 depression patients still being studied, six had significant improvement. One was excluded from the results because she had received another therapy.

So far, there have been no serious side effects or complications, said Kopell, who now works as a consultant to Northstar Neuroscience, the company that is funding the trials, and who holds stock options in the company.

Kopell noted that the research involves pilot studies primarily designed to test the feasibility and safety of the procedure, not effectiveness.

"Whether the effect is durable over the long run remains to be seen," Kopell said. "This is still experimental."

However, "once the kinks are worked out," millions of people could someday benefit from surgery, he said.

Whether it's trying to treat depression, tinnitus or some other neurological condition, the technology is targeted at the cerebral cortex.

The cortex is the most highly developed part of the human brain and is responsible for thinking, perception, memory and other functions such as hearing, movement and emotions.

"What makes us unique as animals is the cortex," Kopell said. "If you can affect the machinery that makes us human, then we have a chance to impact the diseases that are uniquely human. We have work to do before this is therapy."

This week, Kopell and doctors from around the world were meeting in Mexico to present research suggesting that electrical brain stimulation may used to treat a range of disorders, including depression, anorexia, heroin addiction, stroke and obsessive compulsive disorder, and to help people emerge from vegetative states.

The American Tinnitus Association estimates that 12 million people in the U.S. have chronic tinnitus that is severe enough to seek medical help, including 2 million who are debilitated by it.

Parsons' tinnitus actually is two sounds, a constant high-pitched screeching and a pulsating noise synchronized to the beat of his heart.

For a few years, other sounds, such as a noisy restaurant or a waterfall, could drown out the tinnitus, but eventually it became the dominant sound in his life.

He stopped reading books. He avoided social situations unless alcohol was available. Drinking lessened the stress of the noise.

"My own voice would aggravate it," he said.

He went to more than 30 doctors.

"I exhausted the otolaryngologists in Milwaukee," said Parsons.

He went to more ear, nose and throat specialists in other states. The doctors prescribed anti-seizure drugs, anti-depressants, steroids and even low-dose chemotherapy.

"They were just throwing stuff at me," he said. "I actually told doctors if amputating both of my legs would get rid of my tinnitus, I'd do it."

In 2006 he walked into Froedtert after reading about an experimental brain device that was being tested there as a possible tinnitus treatment.

In October of that year, neurosurgeon Kopell removed a section of Parsons' skull about the size of two silver dollars and implanted two electrodes on the dura, the thin membrane covering the surface of the brain. The electrodes were placed over the auditory cortex, which processes hearing. The operation took about two hours and included an overnight stay in the hospital.

It was several weeks before Parsons noticed any big change in his tinnitus.

Then one day, Parsons and his wife were in Chicago for the day. They had come out of an art exhibit and were sitting outside on a bench.

Suddenly, he couldn't hear his tinnitus.

"It was the first time in my adult life I could remember hearing silence," he said. "We didn't talk. She knew how much I was enjoying it.

"It was almost alarming. I had a sense that it was the quiet before a bomb was going to go off. And then I realized that nothing was wrong."

The tinnitus came back in a few hours, but Parsons sensed the implant was working. Over the next year, the tinnitus would diminish substantially.

On a scale of 0 to 100, with 100 being the worst score, Parsons consistently was in the 65 to 95 range before the surgery. Now, it's usually below 35, he said.

"It's like hitting the lottery twice a week," he said.

For 10 years Lynn Steinman found a way to live with her tinnitus.

One morning about five years ago she woke up to the sound of what she thought was the fire alarm going off in her house.

It was her tinnitus, turned up with a vengeance.

"Those next five years were horrible," said Steinman, 58. "I considered suicide."

Whenever she's awake, she hears a sound that's like someone blowing a high-pitched whistle in her ear.

Futilely, she went to doctor after doctor and even sent away for an experimental drug from Africa.

"I felt like a cancer patient searching for anything," she said.

Steinman, a nurse who lives in Edgewater, Colo., heard about the experimental treatment at Froedtert and flew here in November 2005 for the surgery.

After a few months, the noise lessened somewhat, but eventually it went back to the pre-surgery levels, about a 90 on the 0-to-100 scale.

Steinman returned to Milwaukee last week for more exams. She said doctors told her the electrode may be in the wrong place. If testing suggests that moving it might help, she'd consider having the surgery again, she said.

"When you're at the end of your rope, you'll do anything," she said.

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