FDA OK
The experiment allowed the researchers to accumulate efficacy data to show that impaired people would safely be able to bypass injured spinal cord nerves and directly perform operations via a computer. At that point Donoghue began scouting funding to form a company that could develop products based on the research.
The data from the experiments helped Cyberkinetics win quick FDA approval for a prototype implantable device that would let impaired people interface their minds with computers. The electrode array, containing 100 silicon contacts about the diameter of a human hair, is surgically implanted in the area of the brain that controls the arms and hands. A connecting cable runs out to a point just under the skin. Contact is made through the skin with a signal acquisition unit that is connected to racks of computers. Finally, the processed signals are sent to a computer monitor.
At this point, the company has gotten FDA approval to develop the system for five quadriplegic patients, and trials are under way with three. The first patient, paralyzed from the neck down, is now able to move a cursor around a computer screen, draw figures on the screen, open an e-mail program, read the e-mail and then exit the program.
"It was an open question when we began these trials whether someone with Motor Impairment going back a number of years would still have the intact neural functions for this kind of movement," Donoghue said. The clinical trials are verifying the practicality of brain/computer control, and the company is expanding its clinical trials into other areas of nerve damage.
"One of the unique aspects of this technology is that it is not disease-specific. Anytime someone has a normal brain and they are unable to move, this technology might be useful," he said.
While such bypass technology is a start, the recent finding that implanted electrodes can also stimulate nerve growth might be the grail that neuroscientists have long sought in their quest to reverse the ravages of spinal cord injury.
Purdue's Borgens, director of the university's Institute for Applied Neurology, founded Andara Life Science Inc. to commercialize a therapy based on the discovery that nerve growth during embryonic development is guided by electric fields. Like Donoghue, Borgens has spent several decades developing the biological underpinnings of nerve growth, and the simple device he is using to restore nerves in injured spinal cords belies the large amount of work—by a large population of researchers—that made it possible.
