Back to the Future
An electrical device – developed at Purdue and tested at IUSM – is generating new ways to treat patients with severe spinal cord injuries.
At 22, Brandon Ingram knew little about clinical research – that is, until he became a participant in a trial that is generating hope among people with spinal cord injuries and interest from the business community.
Now, at the age of 24, Ingram is convinced his participation in the trial provided options he otherwise wouldn’t have had.
“I’m blessed,” says Ingram who is confined to a wheelchair following a tragic auto accident in 2002. Paralyzed below the waist from the time he awoke in the hospital, Ingram has kept his spirits high and is optimistic he will someday walk again. As it is, , he can stand with the support of crutches.
Ingram was one of 10 people with severe spinal cord injury to participate in a clinical trial at the IU School of Medicine. It was testing a device designed at the Center for Paralysis Research at the Purdue University School of Veterinary Medicine and initially tested in dogs there. Animals with severe spinal cord injury responded well to implantation of the oscillating field stimulator. The next step was testing in humans with paralysis caused by traumatic injury to the spine.
IUSM neurosurgeon Scott A. Shapiro, MD, and the OFS developer Richard Borgens, PhD, had a history of consulting on spinal injury research. Their early research attracted the attention of Mari Hulman George, chair of the Indianapolis Motor Speedway, who donated $2.7 million for matching professorships in the IUSM Division of Neurosurgery and at the Purdue School of Veterinary Medicine’s Institute for Applied Neurology.
Dr. Shapiro, who also is the chief of neurosurgery at Wishard Memorial Hospital, took the lead in the first human trial of the OFS device.
Ten patients with complete motor and sensory spinal cord injury were implanted with the experimental device. All 10 showed some improvement in sensation at six months and the nine patients who remained in the trial also showed improvement one year post surgery, although the degree of improvement varied by patient.
“The patients had no sensation below the level of their injury prior to the implantation of the OFS,” says Dr. Shapiro. “Afterwards, the patients’ sensation was almost back to normal in the immediate area affected by the injury where nerve regeneration occurred.”
On the Right Track
The first human patient got the implant in March 2001. Data from the trial was published in the Journal of Neurosurgery – Spine last January.
“This isn’t a home run, but it warrants additional investigation,” says Dr. Shapiro. “The big question was whether the procedure, which is very invasive and requires two surgeries, is efficacious and the initial results indicate that it is.”
He is now ready to test the stimulator, which is the size of a cigarette lighter, in 10 more patients. Like the first group, these patients also must receive the implant within 18 days of sustaining their injury and the device is removed 15 weeks later.
The OFS device is designed to regenerate nerve fibers, promoting some degree of functional recovery. The device creates an electrical field in the area of injury with alternating positive and negative charges.
“The oscillating field stimulator by itself won’t restore complete function to these patients,” says Dr. Shapiro. “But, we’re on the right track. I believe the OFS device in combination with other drug therapies may provide nerve regeneration in spinal cord injury patients.”
He isn’t the only one optimistic about the promise of the OFS. In April, the device was licensed to an Indiana startup company that will commercialize it. The agreement between the Purdue Research Foundation and Andara Life Science Inc. grants exclusive commercial rights to treatment alternatives with the OFS alone or the device in combination with drugs.
One of those combinations may be another compound tested in guinea pigs and dogs at Purdue and now under the surgical microscope of Dr. Shapiro. Polyethylene glycol (PEG) is a water-soluble waxy substance that has been shown to allow repair of damaged nerves. Dr. Shapiro is cautiously optimistic about that treatment used in conjunction with the OFS.
“At this point, the research isn’t about getting up and walking for these patients, it’s about quality of life,” says Dr. Borgens, Andara’s chief scientific officer. Dr. Shapiro serves as Andara’s chief clinical investigator. They stressed that returning enough sensation to spinal cord injury patients so they can feel potentially life-threatening infections or injuries is an important part of the research.
Andara is an example of the success of collaborations between two of the state’s leading life science universities. The initial clinical trial was partially funded by a special appropriation by the Indiana General Assembly.
Life With a Purpose
Ingram says he doesn’t think of himself as a hero or pioneer for participating in the early research; rather, he considers himself as a beneficiary of this collaborative effort.
“This device changed my life,” he says. Although he only has minor sensation in his toes and can wiggle them when he concentrates, that alone gives him hope. He recently completed a personal computing course at Easter Seals Crossroads Rehabilitation Center and is moving on with his life.
Ingram says his accident and his subsequent treatment made him realize he has something to offer others through a speakers' bureau he founded, Positive Images, he is sharing the word with teens at schools, juvenile facilities, churches, and any other place he is invited to speak.
“I was running around and not paying much attention to anything – just being a kid,” he says. “Now I’ve got a purpose and part of that purpose is to share my story with kids who are on the same path I was on.”
It doesn’t take long listening to Ingram to catch his enthusiasm for life, his goals, his speaking opportunities and his ultimate dream to walk. He is well aware he must be patient so for now, he’s taking it all one step at a time.
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