A Jolt to the System

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In the current study, half of all the patients' devices will be activated for 10 weeks while the remainder stays off. At a later point, the second group will have its devices activated, but the patients won't know when. "We're certainly very excited," says Dr. Mustafa Husain, a lead investigator of the trial at UT Southwestern, "but we want to approach it in an objective way. Our main interest is the safety of the patient."

Patients in the pilot study had commonly gone from one anti-depressant to another with fleeting or no improvement in mood. About half had even tried electroconvulsive therapy--popularly known as shock therapy. Of what results VNS may bring, Rush says, "Our impression so far is that it at least holds over time. It may increase a little bit."

As with the first study, the second trial is funded by Cyberonics, a Houston-based company founded in 1987 that developed and holds a patent on the $15,000 VNS implant and markets it and other medical devices primarily for the treatment of epilepsy and other neurological disorders. Results should be known by 2002, with possible FDA approval to follow.

For Sandoval, six months after the device was implanted, she felt a definite change.

One day, she came to Marangell's office looking like a new person. She'd lost more than 50 pounds and wore, for the first time in many months, light-colored clothes.

"It's changed my whole life," Sandoval said, smiling and sounding as if she were in an infomercial.

"Let me play devil's advocate for a minute," Marangell said. "How do we know that it's not by chance that you're feeling better?"

"Because in my 41 years, the normal pattern has been that I might feel better for a few weeks, a few months, then I'd slip back into depression. Now, there are no signs," Sandoval said.

"Any thoughts of death?"

She shook her head. No.

Sandoval said she'd become more productive. Having moved to Santa Fe to live with her mother, she was now working at an antique shop. "I have energy. I can be with people. It's totally different."

Was she happy? Marangell asked at another point.

"It's not happy," Sandoval said. "It's content. I don't feel sad anymore. I feel everything is going to be OK."

Sandoval now says that like her mother and grandmother, she suffers from a hereditary condition. She came from a stable family; her mother was a teacher, her father was an environmental engineer, and the family lived on a Nevada farm. But early on, Sandoval showed signs of depression. She was withdrawn, a poor student. On weekends, she often sat in a rocking chair for hours, swaying in silence. Her family never understood her dark moods, and she later came to welcome the physical illnesses that befell her: her three bouts with cancer, the sarcoidosis that robbed her of 30 percent of her lung. It was easier at those times to get compassion from people. Of her depression, her family often told her: "Go for a walk. You'll feel better." Or, "What do you have to complain about?"

Sandoval recovered from the cancers and the lung ailment, but the depression stayed. The only thing that has helped pull her back from the brink is the contraption lodged in her chest. Doctors, however, don't know what the long-term effects of VNS might be. It could, for instance, lead to paralysis of the vagus nerve or the growth of a tumor. Sandoval doesn't dwell on such possibilities. "I can have a life without the depression," she says now, speaking by phone from Santa Fe. Throughout the hour's conversation, she occasionally laughs heartily and says that last year, she wrote a Christmas letter to all of her friends and family, telling them about VNS. As if in some rags-to-riches tale, she has even landed a job as an assistant to a movie star in Santa Fe, where she oversees his 6,000-acre ranch.

Sandoval says she'll carry that device for the rest of her life. Her only fear: If the FDA eventually approves it, she'll have to assume the financial responsibility for its upkeep, which includes changing the battery. Typically, the device stimulates the vagus nerve at timed intervals, every hour of the day, seven days a week, until the battery runs out anywhere from three to five years later.

Cyberonics continues to pay for Sandoval's trips to Houston every three months for her checkup. "I don't know what I would do if I couldn't get another battery," Sandoval says, then adds with a laugh, "Doesn't that sound weird?"

If someone told Jimmie Carson that taking a hatchet knife to her hand would end her mental pain, she'd do it. When she tells you this, you believe her. There's something about the way she says it, how she manages eye contact, if only briefly. Most of the time, she has to force herself to focus, all because she lives in a drugged state, her body pumped with four different anti-depressants and Ritalin to boot.

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Lisa Singh
Contact: Lisa Singh