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Approval sought to test brain implant

Neuron-fired device would aid paralyzed people, state firm says

A Foxborough company is about to ask federal regulators for permission to start testing a device that would enable paralyzed people to control computers directly with their brains or possibly help them move their limbs.

Cyberkinetics Inc. will present data at a neurology conference in New Orleans this weekend showing how it developed its BrainGate device after using it in animal trials. It plans to file a research request with the US Food and Drug Administration by the end of the year.

Initially, the device, implanted into the brains of paralyzed people, will help them control a cursor on a screen or play video games. But researchers at Cyberkinetics and several universities believe the technology could one day enable paralyzed people to type, control lights and heating controls, maneuver wheelchairs, or even manipulate robotic arms. Some think such efforts to capture brain impulses could enable such patients to move their arms and legs, which are immobilized because the brain's commands are blocked, such as when the spinal cord is severed.

"Testing these implants in humans is the next step," said Eberhard E. Fetz, professor at the Department of Physiology and Biophysics at the University of Washington, who has been experimenting with brain-signal devices since the late 1960s. "Within a decade, we'll see these being used regularly to control prosthetic devices or activate a patient's own muscles."

Boston University Medical Center is one hospital with spinal cord injury expertise that might participate in the trial, according to Timothy R. Surgenor, Cyberkinetics' president and chief executive. He said the initial trial will involve about five severely paralyzed patients who are unable to use their hands. The study will first test the safety of the implant and also seek to replicate the results achieved with monkeys.

Though there is a lot of research on devices that connect brains to computers, there are still relatively few companies active in what could be a huge new market for medical devices. Surgenor said there are about 200,000 paralyzed people in the United States, including about 40,000 quadriplegics.

"There may be a lot of things we can do to help people overcome disabilities," said Mark Carthy, a general partner at Oxford Bioscience Partners, a venture capital firm that has invested in Cyberkinetics. "In the long run we hope to come out with devices for people who have neurodegenerative diseases," such as ALS, known as Lou Gehrig's Disease, and elderly people who have lost certain functions but have active brains.

Researchers at Duke University last month generated tremendous excitement when they showed a brain implant that enabled monkeys to manipulate a robotic arm with their thoughts. In those experiments, monkeys had networks of fine wires implanted in their brains. They were taught how to move the robotic arm and grasp with the robotic hand using a joystick, like those used to control computer games.

A computer analyzed the brain waves, matching certain patterns with particular motions. Then, the joystick was removed, and the monkeys were able to control the robot arm using "mental intentions."

While several researchers have experimented with devices linking human brains and computers, few have done so in the context of a clinical trial -- a government-monitored series of experiments that can lead to government approval to sell the device.

Cyberkinetics was founded in June 2001 by John P. Donoghue, chairman of the Department of Neuroscience at Brown University in Providence. Last year, the firm demonstrated results similar to those at Duke; monkeys playing a video game with a joystick were able to continue playing moving the cursor with their thoughts.

Sunday, at the Society for Neuroscience's annual meeting in New Orleans, Cyberkinetics will spell out how it has improved the device used in those experiments to make it ready for tests in humans and will outline its plans for the initial clinical trial.

The BrainGate may sound like science fiction familiar to fans of "Robocop" movies, and it could look like it, too. The device is 4 millimeters square, considerably smaller than a dime. It contains 100 tiny wires, a technology the company acquired when it merged last year with Bionic Technologies LLC of Salt Lake City. After making a hole in the patient's skull, the wire array is precisely punched into the surface of the brain.

"There's an inserter, a spring-loaded thing, that taps it into the brain with just the right amount of force," said Surgenor in a telephone interview. The wire array will be positioned over one of the areas of the brain known to control motor activity.

After the implant, the only thing visible on the patient's head will be a connector, not unlike those in the back of a VCR. The computer cable that attaches to it looks a lot like the coaxial cable that delivers cable television, right down to the nut that will tighten it in the socket.

The wires detect when brain cells, or neurons, are fired.

"We'd expect to get signals from 20 to 100 neurons from the array," Surgenor said. "It turns out that when you have more than 20 neurons, you have enough information to decode where in space somebody wants to put their hand."

Surgenor predicted the firm would file to the FDA its application, called an Investigational Device Exemption, by the end of the year. If the plan is approved by regulators, the company hopes to begin the trial early next year and complete the experiment by the end of the year.

Cyberkinetics raised $4.3 million in August, bringing the total investment in the start-up to $9.3 million. Carthy, of Oxford Bioscience, said that is sufficient to fund the company for two years.

"At the end of that, we'd have a lot of data from the clinical trials and we'd be able to outline our commercial stratagem," he said.

Jeffrey Krasner can be reached at krasner@globe.com. Carey Goldberg of the Globe staff contributed to this report.

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