FDA Approves Human Brain Implant Devices

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Associated Press - April 14, 2004

BOSTON (AP) - For years, futurists have dreamed of machines that can

read minds, then act on instructions as they are thought. Now, human

trials are set to begin on a brain-computer interface involving

implants.

Cyberkinetics Inc. of Foxboro, Mass., has received Food and Drug

Administration approval to begin a clinical trial in which four-

square-millimeter chips will be placed beneath the skulls of

paralyzed patients.

If successful, the chips could allow patients to command a computer

to act - merely by thinking about the instructions they wish to send.

It's a small, early step in a mission to improve the quality of life

for victims of strokes and debilitating diseases like cerebral palsy

or Lou Gehrig's. Many victims of such ailments can now survive for

long periods thanks to life support, but their quality of life is

poor.

``A computer is a gateway to everything else these patients would

like to do, including motivating your own muscles through electrical

stimulation,'' said Cyberkinetics chief executive Tim Surgenor.

``This is a step in the process.''

The company is far from the only research group active in the field.

An Atlanta company, Neural Signals, has conducted six similar

implants as part of a clinical trial and hopes to conduct more. But

for now, its device contains relatively simple electrodes, and

experts say Cyberkinetics will be the first to engage in a long-term,

human trial with a more sophisticated device placed inside a

patient's brain. It hopes to bring a product to market in three to

five years.

A number of research groups have focused on brain-computer links in

recent years.

In 1998, Neural Signals researchers said a brain implant let a

paralyzed stroke victim move a cursor to point out phrases like ``See

you later. Nice talking with you'' on a computer screen. The next

year, other scientists said electrodes on the scalp of two Lou

Gehrig's disease patients let them spell messages on a computer

screen.

Cyberkinetics founder Dr. Donoghue, a Brown University

neuroscientist, attracted attention with research on monkeys that was

published in 2002 in the journal Nature.

Three rhesus monkeys were given implants, which were first used to

record signals from their motor cortex - an area of the brain that

controls movement - as they manipulated a joystick with their hands.

Those signals were then used to develop a program that enabled one of

the monkeys to continue moving a computer cursor with its brain.

The idea is not to stimulate the mind but rather to map neural

activity so as to discern when the brain is signaling a desire to

make a particular physical movement.

``We're going to say to a paralyzed patient, 'imagine moving your

hand six inches to the right,''' Surgenor said.

Then, he said, researchers will try to identify the brain activity

associated with that desire. Someday, that capacity could feed into

related devices, such as a robotic arm, that help patients act on

that desire.

It's misleading to say such technologies ``read minds,'' said Dr.

Wolpaw, of the New York State Department of Health, who is

conducting similar research. Instead, they train minds to recognize a

new pattern of cause and effect, and adapt.

``What happens is you provide the brain with the opportunity to

develop a new skill,'' he said.

Moving the experiment from monkeys to humans is a challenge.

Cyberkinetics' ``Brain Gate'' contains tiny spikes that will extend

down about one millimeter into the brain after being implanted

beneath the skull, monitoring the activity from a small group of

neurons.

The signals will be monitored through wires emerging from the skull,

which presents some danger of infection. The company is working on a

wireless version.

But Andersen, a Cal Tech expert conducting similar research,

said the field is advanced enough to warrant this next step.

``I think there is a consensus among many researchers that the time

is right to begin trials in humans,'' Andersen said, noting that

surgeons are already implanting devices into human brains - sometimes

deeply - to treat deafness and Parkinson's disease. ``There is always

some risk but one considers the benefits.''

Wolpaw said it isn't clear that it's necessary to implant such

devices inside the brain; other technologies that monitor activity

from outside the skull may prove as effective. But, he said, the idea

of brain implants seems to attract more attention.

``The idea that you can get control by putting things into the brain

appears to have an inherent fascination,'' he said.

Andersen, however, said that for now devices inside the brain provide

the best information.

``It would be nice if in the future some technology comes along that

would let you non-invasively record from the brain,'' he said. ``MRIs

do that. But unfortunately, it's very expensive and cumbersome, and

the signal is very indirect and slow.''

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