Device to Aid Paralyis Victims to Get Test

A state-funded research pact between Indiana’s top two state universities has yielded its first fruit--a human clinical trial that will test a promising new therapy for spinal-cord injuries.

Purdue University and Indiana University said the Food and Drug Administration has cleared them to test on humans an implantable device that harnesses electrical fields to stimulate nerve growth in damaged spinal cords.

By year’s end, the first participants will undergo surgery to implant the device above their spinal injuries.

The hope is that by feeding weak electrical fields into the injury, the device will spur nerve growth, healing the spinal cord enough to allow the subjects to regain at least some feeling and movement.

The clinical trial is aimed at assessing whether the device is safe for humans.

But the Indiana University School of Medicine researchers who will conduct the trial as part of the Purdue-Indiana University partnership said they are hopeful it will have some therapeutic effect.

“Something will happen. The question is how robust the response will be. We’ll just have to wait and see,” said Scott Shapiro, a professor of neurosurgery at the Indiana University School of Medicine, in announcing the study.

Shapiro, who will oversee the clinical trial, said it will be about a year before the results are made public.

Under the study’s criteria, patients must enter the trial within 18 days from the time of their injury because tests on dogs showed the stimulator worked only on canines treated within two weeks of injury.

Patients must be between ages 18 and 65 and have suffered a complete motor-spinal cord injury below a specified place on the spine. Patients with certain illnesses and injuries may be excluded.

Shapiro said the weak electrical field generated by the battery-powered device--about 600 microvolts per millimeter--mimics that which promotes rapid growth in human and animal embryos.

He said the stimulator, which is about the size of two joined lipstick cases, will be removed after 14 weeks of stimulating the tissue. The device has six electrodes radiating from it, three of which are placed above the spinal injury site, and three below it.

The direction of the current flow is reversed every 10 or 15 minutes, which should encourage nerves to grow toward each other, said Richard Borgens, director of Purdue’s Center for Paralysis Research.

Borgens and his colleagues began work on the oscillating field stimulator in the late 1980s. The device was first tested on dogs with natural cases of paraplegia in the early 1990s, but it has since been fine-tuned in anticipation of human trials.

In the series of dog trials performed to date, about 85% of the canines showed improvements. A few even regained the ability to walk, said Borgens, a professor of developmental anatomy.

He said adapting the device for use in humans couldn’t have been possible without $2 million in state funding approved in 1999 for the joint Purdue-Indiana University initiative.

Researchers from the two schools are working on a number of other potential treatments for paralysis.

During the announcement, one of the dogs successfully treated during the Purdue animal tests roamed the stage as his owners described how 7-year-old Yukon was able to walk again when he was treated by Borgens’ team, following a 1996 injury that paralyzed the canine’s hindquarters.

Then came 19-year-old Nichole Richards of Indianapolis, who was paralyzed in a car crash and wept as she described how her life had changed since the accident left her in a wheelchair and with limited use of her arms.

“What’s going on here is making all of us anxious and excited and we hope that what they’ve been able to do with dogs they will eventually be able to do with humans,” she said.

Richards, a former gymnast who had dreamed of being part of Ball State University’s women’s gymnastics team, is not a candidate for the Purdue-Indiana University clinical trial because her injury occurred in February.

The joint initiative is one of a handful underway worldwide, including the controversial transplantation of fetal spinal-cord tissue, said Naomi Kleitman, education director for the Miami Project to Cure Paralysis.

If any of those therapies prove successful, they will add to the limited “toolbox” of therapies doctors can dip into to treat the wide range of spinal-cord injuries, as well as related trauma such as head injuries, said Kleitman, an adjunct associate professor of neurosurgery at the University of Miami’s School of Medicine.

During the announcement of the Purdue-Indiana University study, the chairwoman of the Indianapolis Motor Speedway said she is donating $2.7 million to the schools to create endowed professorships to promote paralysis research.

Mari Hulman George, a dog lover known for her work saving abandoned greyhounds, said her main motivation in making the donation was a spinal injury her grandson, Jarrod, suffered in a bicycle accident when he was 9.

Although he eventually recovered from his paralysis and is now a healthy 18-year-old college student, she said spinal-cord research is crucial to the roughly 10,000 Americans paralyzed each year.