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During the course of the study, Kelley stayed with relatives in New Jersey and commuted to the Washington Heights hospital. Although one of the eligibility requirements was that patients live in the vicinity, she was surprised to learn that several other participants were also temporarily living with nearby relatives or traveling long distances. Among them was Michele Merdinger, a Philadelphia resident with bipolar disorder. Like Kelley, she had tried dozens of medications and ECT, all to no avail. Her life had been ravaged by the illness: She lost numerous jobs, was hospitalized more times than she cares to remember, and could barely maintain friendships.
For both women, the surgery was uneventful. The procedure, usually about $15,000, was free to them as subjects of a clinical trial. The $12,000 battery-operated stimulator, donated by Cyberonics, the manufacturer, was inserted into the chest just below the skin. Electrical leads were connected to the left vagus nerve. The surgery took less than an hour and barely left a scar.
During the hours the two women spent together on weekly follow-up visits to the lab, Merdinger and Kelley compared notes on how the VNS was working. It was unclear at first if the device was doing anything but making them uncomfortable. Every time the stimulator fired, a 30-second pulse of electricity was sent up the wire and to the electrode on the vagus nerve, giving them a jolt that they could feel.
"I would get excruciating pain through my jaw and through my teeth," Kelley said, although that was fixed by a minor adjustment to the device. "I would make these weird moo-like sounds in my sleep because I had it turned up so high. It was rattling my vocal cords."
After about nine months, Kelley was the first of the two to feel her depression begin to lift. Unlike some medications, which painted over the depression with a chemically induced detachment or energy, the VNS actually seemed to sweep the depression away. "It was a complete remission," she said. Meanwhile, Merdinger was improving at a much slower pace. "It almost crept up on me," she said. "There was never one day where I could pinpointI just remember being able to look back and say, 'I feel a hell of a lot better today than I did a couple months ago.'"
Both women were among the 29 percent in the study who felt their depressions melt away within a year after surgery. In 2002, Lisanby and her colleagues published those findings in the journal Biological Psychiatry, describing the results as slow-acting compared to ECT, which can have an antidepressant effect almost immediately, or medication, which usually takes a couple of weeks to kick in. Despite the snail's pace, both researchers and their successful subjects were excited that the radical new treatment was effective on people who'd never responded to anything else. Re-energized and feeling alive again, Kelley testified at a 2004 FDA hearing for the device.
"I am not going to idealize nor sentimentalize the device," she told the panel. "I know I am one of the third who have responded to it. I know there are others who continue to suffer the burden of treatment-resistant depression. I see it in their faces as I sit in the lobby and wait my turn at my site. I know that pain I suffered it prior to the VNS. Still, I have windows of it now and again." But the option to receive this potentially life-saving surgery, she added, should be made available to others.
The FDA approved VNS as a treatment for depression in November 2005, and the brain-stimulation unit ( in collaboration with New YorkPresbyterian Hospital ) became the first place in the metro area to provide it. Soon after the FDA approval, both Merdinger and Kelley had replacement generators implanted, which were donated once again by Cyberonics. The new devices provided a much longer battery life.
Unfortunately, Kelley's FDA speech turned out to be prescient of what was to come. Soon after, those windows of depression that she'd hinted at became more frequent. "I'd have three good weeks and then three bad weeks. We'd adjust the parameters, and then I'd have three good months and then three bad. More adjustments." After she'd maxed out the settingsthey were so high that she had to endure air obstruction, jaw pain, hoarseness, and muscle spasmsshe went back on medication. Lisanby has a few theories about why the device stopped helping Kelley, but ultimately, she said, "it's a mysterywe simply don't know."
Steve Blackman receives treatment for Tourette syndrome.