Dr. McDonald discussed the results of a three-year study involving multiple SCI patients with various levels of injury and varying lengths of time post-injury. The study included patients with injuries as high as C-2 and post-injury time as far out as 20 years. Dr. McDonald said early data from his clinical work indicates patients who use the bicycle for one hour at a time, three times a week, can avoid many of the physical complications associated with spinal cord injuries, while animal research in the lab shows the activity can stimulate new cell growth and activity.

Dr. McDonald pointed out that the conditions to optimize spontaneous regeneration are not present after a spinal cord injury and some are actually counteracted by certain medications like Baclofen and Valium. A growing body of evidence indicates that one of the conditions to aid spontaneous regeneration is patterned neural activity.

Simply stated, patterned neural activity is the establishment of nervous system pathways caused by repetition of an activity. In this case, the activity is the repetitive electrical stimulation of certain muscle groups in a pre-arranged pattern. This sensory pattern results in a neural pattern being formed. To achieve a neural pattern through functional electrical stimulation (FES), the therapy was done three times a week for one hour each session. The process involves the patient being seated on a bicycle-type piece of equipment with electrodes attached to the muscle groups in the thighs and calves. These electrodes are then fired in a pattern that controls each leg to simulate the activity of riding a bicycle. The hour-long session provides 3000 repetitions; this is a far cry from the average 12,000 steps a person takes each day yet it is getting results.

Dr. McDonald presented the case of a C-2 ASIA A Complete patient who was five years post-injury. The patient had a history of nine complications ranging from UTIs to pressure sores prior to FES therapy. He had incurred 49 various infections resulting in a total of 527 days of antibiotic treatment. In the three years since beginning the FES therapy, the patient has had one major complication, has had only 9 infections resulting in 64 days of antibiotic treatment. That's a remarkable change in quality of life.

In addition to decreasing the complications to the patient, the FES therapy provided functional benefits. The patient began the study with motor scores of 0, light touch and pinprick scores of 0. These scores are determined by rating 28 different muscle groups with a range of 1-5 for a total score of 140. After three years of FES therapy at one-hour sessions three times a week, the patient has motor scores of 20. Although this may not seem like much, it is significant to point out that the best increase in motor scores for methylprednisone have been 4.8, nowhere near the 20 shown in this patient. Methylprednisone is the steroid injection given to control swelling and inflammation after a spinal cord injury and must be given within 48 hours of the trauma. FES therapy is showing better results and has no time limit post-injury. Not only did the FES therapy restore a 20 point increase in motor function in the patient presented, it also returned the light touch sensation score to 80 and the pinprick sensation score to 50.

Dr. McDonald is about to begin a broader clinical trial with 120 patients. They will take part in using FES bicycles at his lab, but he hopes to increase participation by getting some of the bicycles into patients' homes.

Until now, that's been cost prohibitive. The bicycle was originally designed in the late 1970s for acutely injured people who might be able to recover in the first couple of months, but was not intended for people who have had their injuries for a long period of time. Only about 700 of the bicycles have been produced in the past 25 years, and they cost about $14,000 to $16,000 each. McDonald is working with a manufacturing group whom he declined to identify to redesign the bicycle and reduce the cost by as much as 50%.

Patrick Rummerfield, director of performance assessment for the spinal cord injury program at Washington University School of Medicine, says there's a huge potential cost savings for insurance companies because of the physical benefits of FES bicycle therapy. Those physical benefits include building muscle mass and preventing skin breakdown, decreasing spasms that are typically treated with medication, building bone density to prevent osteoporosis and bone fractures, and enhancing bloodflow and cardiovascular activity. "One bone fracture costs $70,000 for hospital treatment. Skin breakdown can cost $60,000. A bladder infection can run in the tens of thousands of dollars," Rummerfield said. "If you can get the cost down, hopefully the insurance companies will realize this is saving them a lot of money." Rummerfield said McDonald's work "is light years ahead of anything that's ever been produced." Funding for McDonald's work has come primarily from private donations so far. He's just begun to apply for federal grants and for grants from the Christopher Reeve Paralysis Foundation to pay for the research project, which he said will cost about $750,000 a year.Researchers who work with McDonald include Dr. Daniel Becker and Charlie Li, who have worked on demonstrating the role of physical activity in cell regeneration; Dr. Christina Sadowsky, a specialist in spinal cord injuries; Linda Schultz, clinical nurse specialist; and Jenny Edrington, who is coordinating the clinical trials. More information about the trials is available at the spinal cord injury program's Web site, http://www.neuro.wustl.edu/sci.

Kris

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