The Human Element

Editor's note: In this issue, we speak with Blair Calancie, Ph.D. about clinical and rehabilitation research in the Project's Louis and Virginia Bantle Rehabilitation Research Center. We particularly want to acknowledge the contributions of our volunteer research subjects, SCI individuals who make our progress possible. Many more people volunteer than our research facility can accept. Our goal is to benefit all by the knowledge we gain in our studies.

Laurie Sheradsky assists Steve Ammanniti on the monorail suspension system as John Beauregard looks on.

The Miami Project is a research center- how does it differ from a clinical program that also does research?

That's the basis for a lot of confusion for many of our first-time visitors because they typically will expect the Miami Project to be a treatment center and, of course, it's not. I think most people, when they've toured and actually had the benefit of seeing the full scope of the Project, accept us for what we are, a spinal cord injury research center that includes clinical components, some of which they may or may not be appropriate for.

How do you decide which subjects to study and how do you set the criteria for a particular study?

We deliberately address the different subcategories of SCI because the injury itself is so wide-ranging. For example, we've recently published work with a triceps stimulator for persons with high cervical injury who have little or no recovery of volitional function-what can be called "complete quads". Chris Thomas's work is also directed towards upper extremity studies of persons who either are complete or incomplete quads. We have, by way of contrast, studies using the Parastep stimulator, which included subjects with complete thoracic lesions, and our body weight support studies, which are directed toward persons with incomplete thoracic or cervical level of injuries. In the male fertility program, Drs. Brackett and Lynne also study persons with either complete and incomplete injuries. So, we include in our studies complete, incomplete, cervical, thoracic.

Having said that, the studies that are then initiated certainly reflect our own interests and our own areas of expertise. My interest is in the physiology of the spinal cord and reflex organization, so many of my studies have looked at alterations in reflex properties: spinal stepping, spasticity, spinal shock. These all have practical consequences, so, understanding the basic mechanisms associated with these changed reflex properties may lead us to approaches that we may be able to show are therapeutic or beneficial.

Is the Bantle Center's emphasis on understanding human SCI or testing new treatments?

I think new understanding is the biggest role that we have to play at this stage. Applying specific treatments has been of secondary importance, however, when there are specific opportunities to apply newfound knowledge to interventions, I think we've been quick to act on that. The male fertility approach is one example; intraoperative monitoring is another.

As I've said on more than one occasion, as a clinical neurophysiologist, I'm not going to cure SCI. I see that coming out of the wet labs, the cellular, the molecular, the bench-top basic science side of research. However, that's not to diminish what I perceive to be the importance of the investigators on the clinical side of things. Depending on what approach is developed, now the basic scientists are going to turn to us to say "this is what we've got; who do we try it on? Where do we start? How do we evaluate it?" By understanding the natural course of the injury, we anticipate being in a better position to help guide the basic scientists into, firstly, developing the most appropriate intervention, and secondly, being able to recommend who to try and when, and then how to evaluate it.

Laurie Sheradsky and Carolyn Mata set up Steve's harness monitor for the study.

The key to benefitting more people than can come to Miami is to get our findings out and to have others accept them. Is that happening?

I agree, the best method of communication is publication in peer-reviewed scientific journals, in theory. In practice, the one-on-one communication can be invaluable and there's no question we've benefitted from our lecture series by having senior investigators come to the Project. As far as other centers utilizing the information, that hasn't had a chance to happen yet with the Parastep program; those papers are just coming out, though the results [showing improved strength, cardiovascular function and psychological measures] have been presented at national meetings.

With respect to the triceps stimulator developed here, a study by Needham-Shropshire, et al., just appeared in The Journal of Spinal Cord Medicine. I'm hoping that this technology will be embraced by the rehab community. It is a simple device that's in common manufacture, the arm-crank ergometer, and relatively simple stimulation technology that will give potentially significant functional improvement for a subcategory of persons with high cervical injury. Our work argues that you can see improvement in function in people who are years post-injury.

You were a part of the team that created a new intraoperative monitoring technique. That was picked up rapidly, wasn't it?

It's true. In fact, I've had one orthopaedic surgeon who visited inform me that, "We've been using that in our center for five years." I looked back in our records, and it was first presented just about six years ago at orthopaedic meetings. From a practical point of view, it was a very rapid turn-around for us to take the concept, develop it through the animal model, and then take it to the clinic within a matter of about three years.

It's probably worth pointing out that I approached the NIH on two different occasions with a grant proposal to fund this work, and it was deemed to be inappropriate, not hypothesis-driven, and of low priority. Unfortunately, that's not atypical for some very clinically relevant work.

And the male fertility research program?

Besides methods of assisted reproduction, they have also been studying in great detail the factors that are responsible for the decline in fertility that is commonly associated with SCI. There were a number of factors that, through common folklore, had been suggested to be detrimental-temperature, seating position, lack of mobility, etc.-which can probably be ruled out. They are now honing in on one or two factors that appear to be primarily responsible for this reduced fertility.

One of their recent publications showed that some men can respond to a special vibrator rather than going through electroejaculation, and that sperm motility is better with the less invasive technique, even from the same man. That means reduced expense, reduced time, reduced discomfort and fewer side effects. Everybody benefits, especially if you can use a less invasive approach and get a better outcome.

That study also brings up the extraordinary cooperation that we almost take for granted from our research population. For a person with an incomplete injury the electroejaculation is, to say the least, uncomfortable. Some men learned through these studies that they can get good responses with vibration, and yet they were still willing to subject themselves to the more invasive, more uncomfortable technique, to help us answer this question.

Not all clinical research benefits the subjects, does it?

One of the things that we routinely will tell our subjects is that what we're doing may not benefit them directly but what we learn may be of some benefit to other persons with SCI. And one of the overwhelming constants in our subjects is their willingness to accept that aspect of the study as being appropriate and justifying their participation. We've heard so many times, "I've come to live with myself in this chair and it would be great if I could get up and walk someday; if you guys come up with a cure I want to be first in line. But in the meantime, if what you do here can benefit someone else who's just recently in a chair, who has just had an accident, that's enough for me."

Most of all, I want to convey a sense of-appreciation isn't enough-a sense of gratitude to our subjects. Most of them are willing to accept the idea that we don't have a cure today or next week or next month or next year, and they're taking it with tremendous patience and cooperation, which makes our job tremendously more pleasurable, easier, more satisfying. When we do come up with something where we can see that some of these patients actually are benefitting, that's even better!

A study in motion.

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