In a recent interview, Illinois resident Christopher Ware talked to Medical Device Daily via cell phone while driving to New Jersey for a friend's wedding.

And not just once, but twice he noted that he was steering with one hand while holding the cell phone with the other.

Not a huge feat, you say – no, not at all for you and me, or the driver closely behind on your bumper.

But for Ware, it is huge. A huge step for a young man, when in 1997 – and not yet in his 20s – he suffered a stroke that incapacitated him.

“I was totally incapacitated,” he says. As the result of the stroke, he suffered paralysis of the right hand and arm, right leg and foot. “I couldn't walk or talk.”

Overall, his deficits were so extreme that his doctors in Bloomington told him they saw little chance for much recovery and that his next step was likely a nursing home.

But he refused that choice and worked hard at rehabilitation, with some effect.

“I had made some progress using my right leg, and was able to move my arm. But I couldn't do fine motor tasks with my right hand, I couldn't tie my shoes, I couldn't pour anything. My right hand was basically useless.”

Then, seven years following the stroke, he learned of the EVEREST trial, a study of the cortical stimulation technology being developed by Northstar Neuroscience (Seattle), a system that involves stimulating the prefrontal cortex of the brain as therapy for stroke and other neurological conditions.

Following enrollment and device implant, Ware made progress. It wasn't small or slow to come either, but rather “immediate,” he says.

“I started to make progress within the first week. I could tie my shoes for the first time in over seven years.”

Among his deficits was spasticity in his right hand. That too went away, and he was then able to move his fingers, pick things up and perform small motor tasks.

“When I could move every finger for the first time in seven years, that was amazing,” he says.

Following treatment with the Northstar system, it was removed in accordance with the trial protocol. Since then he continues to make progress.

“I stopped rehabilitation in November, but every day I work at it and keep improving, even without the device.”

Ware is obviously a vivid success story coming from the trial. Since it is ongoing, results won't be known for several months, but Alan Levy, PhD, president/CEO of Northstar, says that Ware is hardly an exception.

While patients in the trial are receiving treatment an average two to three years post-stroke, he notes that one patient treated eight years post-stroke is doing well and also made good progress.

With the success of its preclinical work to date, underlined by its huge potential for ameliorating the effects of stroke for patients – and not less importantly for families – Northstar earlier this year pulled in about $100 million in its initial public offering, one of the largest for the year in the med-tech space (Medical Device Daily, May 8, 2006).

The system's potential huge benefit is to return stroke patients to work and play, by what Levy calls, at the basic level, a “rewiring” of the brain.

“It's more complicated on a cellular level,” he says, and still not fully understood. But he says that “neural plasticity” is a natural ability of the human brain “to reorganize in response to an injury or stimulus. It's a well-known phenomenon, and with regard to stoke, what it means is that when part of the brain dies because of stroke another part of the brain begins to take over some functions.”

But, he adds: “In most cases this doesn't go far enough. Most [stroke victims] recover relatively little function, but if you stimulate the neurons in the neural plastic area with the appropriate parameters, you can enhance this.”

Northstar's device may be compared to sort of pacemaker for the brain, with a small electric pulse generator implanted near the collarbone, with wiring then traveling up under the skin of the neck into the area of the brain where a small stimulator – “postage-size,” says Levy — is placed not in the brain but on its outer layer, the dura.

Exact location of placement is critically important, he emphasizes.

“We identify the neural plastic area by an imaging technique called fMRI [functional MRI]. The patient is placed in a chamber and told to keep his body still. Then he's told to move the limb we're interested in, and if he's able to move it even a little bit, a part of the brain controlling that limb lights up. That's the place to stimulate.”

Patients in the EVEREST trial are treated no sooner than four months, post-stroke, Levy notes, so that the natural points of recovery and recovery produced by the cortical stimulation can be differentiated.

Those being treated in the trial are in the “middle two groups” of stroke patients, Levy notes: the moderate and moderate-to-severe patients, as opposed to those in the mild and severe categories.

“It's easier to recruit patients more impaired than just mild,” he says, though he expects that the studies and applications will later move to treating those in the mild category.

Those in the severe category may be too impaired to receive stimulation benefit, he notes, if unable to move a limb to indicate the potential for device placement.

The treatment involves a “steady stream at low levels” of electrical stimulation two and one-half hours each day during rehabilitation, says Levy, to “strengthen the relatively weak connections between the neurons and the neuroplastic area.” This is done over a six-week period and then the device is removed.

EVEREST will enroll 151 patients, 100 receiving a regimen of rehabilitation/device therapy, the rest in the control group receiving the same rehabilitation but no device.

Levy projects completion of enrollment “no later than next year,” with trial data analyzed and reported in the first quarter of 2008. Patients will be followed formerly for six months, he notes, “informally for at least three years.”

A hoped-for market release could come in 2009, Levy projects, with the current funding sufficient to take the company through 2010, he says.

Meanwhile, Northstar is moving ahead to explore other rehabilitative applications in the areas of neurologic diseases and deficits.

Early this month, it received FDA approval to conduct a clinical feasibility study of its system in treating depression. The study will assess the safety and effectiveness of investigational cortical stimulation for patients diagnosed with major depressive disorder who are not responsive to other antidepressant treatments, a group of patients it puts at 4 million in the U.S., or about one-quarter of those suffering crippling depression.

This trial will enroll up to 12 patients studied at three sites: the Medical College of Wisconsin (Milwaukee), Massachusetts General Hospital (Boston), and the University of Pittsburgh.

“We have achieved promising results in previous feasibility studies of cortical stimulation for arm/hand disability following stroke,” says Levy, adding: “This is the first study that will explore our cortical stimulation therapy in the growing and important neuropsychiatric field.”

While obviously seeing huge benefits for Chris Ware, Levy says the company's cortical stimulation approach “is something much larger than for the 5 million people with stroke.”