ROCKVILLE, Md. (AP) — A surgical implant soon may offer some people with partial paralysis the chance to restore their ability to grasp a fork or a pen, even to paint.
Scientific advisers recommended Wednesday that the Food and Drug Administration approve Freehand, putting it in position to become the nation’s first neural prosthetic to restore function to a paralyzed limb.
Experts emphasized it’s not a cure for paralysis. Only certain partially paralyzed patients could use it, not the severely injured like actor Christopher Reeve. Although it would help eligible patients to move their fingers and thumb, it won’t let them speed type or play the piano.
“We mustn’t give false hope,” said Dr. Michael Keith, a Case Western Reserve University orthopedic surgeon who helped colleague P. Hunter Peckham create the device.
But now, “for most of these patients, there’s darn little,” Keith said. “We’re going to give them more motor control so they can … do more things, without assistance, hesitation and delays.”
Today, such patients get some help from external devices that let them type on computers by blowing into a mouthpiece, or feed themselves with a fork strapped to a hand.
The Freehand, to be sold by NeuroControl Corp. of Cleveland, is designed to give more independence and better motor control to an estimated 54,000 Americans with spinal cord injuries that caused a certain type of partial paralysis. These quadriplegics retain some movement of their shoulders and arms, essential to use Freehand.
Freehand essentially is an electronic substitute for the brain’s nerve impulses that, in a healthy person, would tell their hand muscles to move. It is implanted into the chest and connected to the hand muscles by electrodes threaded under the skin.
Only one hand can be implanted, because the device is controlled by a small joystick worn under the clothing at the opposite shoulder.
When the patient gives that shoulder a slight jerk, the implant gets an electronic signal that tells the thumb muscle to move toward the fingers in a “pinching” motion. Jerk the shoulder harder or faster and the hand pinches together faster to grasp a fork or pen.
Tap a button on the chest with the arm, and the device forces the muscles into a more intricate movement to grasp a larger object like a cup.
Two hand movements don’t sound very impressive, Keith acknowledged, but his evidence that it’s more than it seems comes in videotape NeuroControl made of the 38 patients who have used Freehand.
One, identified only as Kathy, previously needed someone to pour her coffee, stick a fork into her hand and wedge a telephone between her shoulder and her ear.
With the device, Kathy did all that herself and even put on her makeup, albeit while continuously jerking her shoulder in a manner resembling a nervous tic. Keith said since that with the implant, the woman has moved out of a nursing home, regained custody of her children and is receiving job training.
FDA advisers called Freehand impressive but warned that it will not benefit every patient and that some won’t want it.
Doctors must be trained to implant the electronic hand safely, the FDA advisers insisted. They recommended the FDA approve Freehand only after NeuroControl provides more data on how safe it is to use around cellular telephones and MRI scanners in hospitals, machines that use electronic frequencies that might interfere with the paralysis device.
The FDA usually follows its advisers’ recommendations, although it is not bound by them.
Getting the implant takes about three months, at a cost of between $40,000 and $50,000.