Thanks to Susan Harkema and her team, four completely paralysed patients have been able to voluntarily move their legs again. Now the American neurologist and epidural stimulation specialist is putting her findings to the test with The Big Idea, a study involving a further 36 patients. But before she can begin, preparation and approvals are needed.
Dr Harkema, let´s start at the beginning: what was it like when the first patient was able to move his leg?
It was shocking and mystifying. At first I didn’t believe it and thought it was the stimulation directly moving the leg. But then I had him lay back, close his eyes and move on my command. And, yes, it worked again. It was astonishing and made me reassess how the human nervous system controls movement. The spinal cord must have a very significant level of control of movement for this to occur in someone who, as far as we can detect, is receiving no input from the brain to that area.
When will you start work on The Big Idea?
There are a few preconditions for such a large study. The most important is approval from the FDA* and the relevant ethical review commission. Then you need support from technology companies for the electronic equipment and availability at the hospital. And, last but not least, you need enough patients who both fit the criteria to be included in the study and can spend a certain amount of time with us here in Louisville. We are working on all of these now and will be able to start when we have reached all these objectives.
How long have the preparations taken?
Many months. We began with the early design of this study almost two years ago. We brought in experts in the field, set up an advisory board and revised the protocol based on all of their input. We have also learned a tremendous amount from ongoing studies we are doing in the laboratory now to help us prepare for a larger cohort of people with severe paralysis.
What are the greatest challenges?
Four very specific areas: receiving sufficient funding, getting the go-ahead from the authorities, having access to the right technology and training the research team. How many people are working on the study? I would say at least 50, including investigators, research staff, collaborators, physicians, therapists, and advisory board members.
What are the criteria for selecting patients?
In general, the person must have significant deficits in cardiovascular function and be unable to stand or move all of the joints of their legs voluntarily. These most likely would be people with ASIA A, B or C classifications ** and most often are people with upper thoracic or cervical injury. However, the criteria are based on the deficits, not the level or ASIA classification exclusively.
What’s the breakdown of patients in terms of sex and age?
We won’t know that until we complete recruitment. However, most people with SCI are male and below the age of 50, so it’s likely this group will be represented more.
There’s normally a control group which isn’t treated or doesn’t receive medication. How will that be managed in this case?
Each research participant will serve as their own control. Other control groups will compare the effects of stimulation alone to stimulation with intensive task-specific.
Thanks for sharing your work with us. We wish you all the best for the following steps of your study.
* Food and Drug Administration, an American federal agency
** Classification system for the severity of loss of function, as developed by the American Spinal Injury Association:
A = Complete, no motor or sensory function is preserved
B = Incomplete, sensory but no motor function is preserved
C = Incomplete, motor function is preserved
THE BIG IDEA
Project leader: Dr Susan Harkema
Initiator: Christopher & Dana Reeve Foundation
Study due to start: Early 2016
Duration: Five years
Location: Louisville, USA
Number of patients: 36
Overall cost: at least $15 million
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