Wednesday, July 04, 2007

Nerve Repair Innovation Gives Man Hope

After spinal-cord injury, Cyberkinetics' device restores some function for paralyzed patient


Nearly five years ago, Brandon Ingram rear-ended a car while driving west on I-70 near Keystone Avenue and crashed through his windshield.

The accident broke four of his ribs and punctured the then-22-year-old's lungs. He was covered in bruises, and doctors had to sew his eyelid back together.

But that wasn't the worst of it. The Indianapolis resident was paralyzed from the waist down.
Thanks to the work of a company with strong Purdue University roots, Ingram now lives independently with his wife, Aisha. He has regained some key functions, and if he thinks about it, he can wiggle his toes, and he can walk with the aid of braces and his upper body.

Ingram, now 27, works at a cable TV firm and also does motivational speaking through his company, Positive Images.

"The device gave me hope, not only physically, but mentally. That device changed my life," he said. "They didn't think I was going to make it."

The device he's referring to is the Andara Oscillating Field Stimulator, a small, pacemaker-sized box that can regenerate damaged nerve fibers and restore some functions. It's under development by Cyberkinetics Neurotechnology Systems, which bought out West Lafayette-based Andara last year.

Cyberkinetics, based in Foxborough, Mass., has pioneered several technologies for spinal-cord injuries, including the NeuroPort System -- designed to record and monitor brain electrical activity -- which has been cleared to market in the U.S.

Another of its innovations is the BrainGate System, designed to provide communication and control of a computer, assistive devices and, ultimately, limb movement. The BrainGate now is in human clinical trials.
But the company's main focus now is the Oscillating Field Stimulator, which has been tested in Ingram and 13 other patients with severe spinal injuries and is up for a special humanitarian device exemption from Food and Drug Administration.

If the government gives the go-ahead, the Andara device would become the first major advance in treating spinal-cord injuries since World War II.

Cyberkinetics -- which has 56 employees in Indiana, Massachusetts and Utah -- licensed the technology for the device from Purdue.

"The (OFS) technology obviously was born there. The experience and resources at Purdue . . . (and) the scientific know-how . . . is relied on heavily," said Mark Carney, who co-founded Andara and now serves as executive vice president and a director of Cyberkinetics.
Specifically, the Oscillating Field Stimulator technology was born at Purdue's Center for Paralysis Research.

The center's director, Richard Borgens, discovered in the mid-1970s that low voltage could regrow damaged nerves. In the '90s, Borgens developed a machine that could do that in humans.

"It would be the only regenerative therapy that has ever been available to patients" if it's approved by the FDA, said Borgens, who co-founded Andara.

He said that, since the middle of the last century, patients and doctors have had two methods of treating spinal-cord injuries: surgery, to lessen pressure and stabilize the back; and physical rehabilitation. In the mid-1990s, steroids were introduced, but the medical community is split over their effectiveness.

"With traditional spinal injuries, there's very few positive results," said Gerald Szkotnicki, director of the Clarian Neuroscience Center of Excellence, a program that aims at furthering the development of neuroscience. "Anything that could provide a benefit for a patient is being sought after worldwide."
Borgens said that the clinical trials for the Oscillating Field Stimulator gave unexpected results: quadriplegics regained the use of their hands; paralyzed patients could feel their feet again. "Indeed, these people have significant change in their quality of their lives for the better," he said. "I would've been amazed if they had improved half as good as they did."

Dr. Scott Shapiro, chief of neurosurgery at Wishard Memorial Hospital and a professor of neurosurgery at Indiana University School of Medicine, is in charge of the human trials. He said the Andara device shows great promise, but is by no means a silver bullet for spinal injuries.

For one thing, it's expensive: Each device is expected to cost $40,000 to $50,000. It also needs to be used within days after an injury in order to be effective.

"It's safe. It's easy. If we prove it, it's a first step and a pretty good step," Shapiro said. "It's not a cure."

But as far as Brandon Ingram is concerned, it is. He can get in and out of the car again, dress himself, take a shower.

"I can do everything at home," Ingram said. "It regenerated me. It was just a wonderful feeling."

By Chuck Bowen