“Ground-breaking research could change the lives of millions.” You have read the headlines, but what happens when the spotlight dims, and the researcher goes back to the lab? How often do you see the resulting groundbreaking treatment or product in your hometown clinic or used by your loved ones? You may not know about the difficult challenges that must be overcome to bring these therapies to the people who need them.
A Lifetime of Research
Dr. Jonathan R. Wolpaw, Director of the National Center for Adaptive Neurotechnologies (NCAN), is internationally known for his 35-years of cutting-edge research in spinal cord plasticity, the nervous system’s ability to rewire and shape itself in response to the demands of function. Now, Dr. Wolpaw and his collaborator, Dr. Aiko Thompson at the Medical University of South Carolina, have created a new medical device to harness spinal cord plasticity to help people with neurological disorders.
Reflex abnormalities that disrupt muscle control are common in people with chronic neurological disorders. Affecting people with stroke, traumatic brain injury, multiple sclerosis, and cerebral palsy, they make movement difficult, painful, and sometimes even impossible. For example, people with spinal cord injury (SCI) often have spastic hyperreflexia (overactive reflexes) that impairs walking or other important motor functions. Current rehabilitation treatments, such as neuromotor retraining and stretching, and medications such as baclofen or botulinum toxin, address overall motor function but do not specifically target the underlying reflex abnormalities.
Unlike standard treatments, Spinal Reflex Conditioning targets reflex pathways specifically and it produces beneficial plasticity in the abnormal reflex pathways. Patients participate in a training program that produces long-term changes in neuromotor control of functions like walking. The beneficial effects persist long after treatment ends. After treatment with this training protocol, even patients who had chronic walking deficits walk faster, traverse greater distance, step more easily and have better foot placement, reduced spasticity, reduced foot drop, improved balance, and decreased use of assistive devices. In short, reflex-conditioning training with this technology can greatly improve motor control and hence quality of life for these patients. This new highly focused therapeutic approach can complement conventional less-specific therapies and enhance functional recovery for many people with spinal cord or brain injury, stroke, multiple sclerosis, or other chronic neuromuscular disorders.
Translating Research into Product
Health Research, Inc. (HRI) is a non-profit affiliate of the New York State Department of Health. Its technology transfer program facilitates the development of research discoveries made at the Health Department’s laboratories, including the Wadsworth Center, the home of NCAN where the research and development of this technology was initiated and is still taking place. HRI’s technology transfer program works to ensure that the scientific and technological developments of Department of Health researchers are made available for the advancement of public health. By partnering with public and private institutions, HRI delivers the resources necessary to translate research findings into products for the prevention, diagnosis, and treatment of disease. Since translation of NCAN’s rehabilitation device into a clinically available treatment involves unique challenges, HRI applied for an assistance grant from the Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT).
Commercialization Pearls and Pitfalls
Based in the Upper Connecticut River Valley of New Hampshire, with partners in Boston, TREAT’s mission is to bring evidence-based rehabilitation research into the market place where it can have a wide reach and get to the people it is intended to help.
“TREAT is using a methodology that is unique,” says Robert Gallo, Director of Intellectual Property and Licensing at HRI. “TREAT’s framework has made the process of taking an invention from the lab to market more understandable to our researchers.” TREAT provided a strategic assessment to the HRI and NCAN team and, first, encouraged them to talk to potential users of the Spinal Reflex Conditioning system to find out what information these users would require before they were willing to purchase and use a product that delivers this therapy. The team thus discovered the issues critical to the future adoption and success of the technology; these could then be addressed with forethought and strategy.
One of these issues happened to be a common barrier for new technology in physical rehabilitation: the existing payment structure for delivering physical therapy. When providing patient care, physical therapists are typically reimbursed a fixed amount by insurers based on the time spent with the patient during the therapy sessions and specific activities performed, not on the value of that care or improvement in clinical outcomes. Even with trends toward value-based payment models, private and public insurers cap the number of sessions a patient can receive and the opportunity to show clinical and cost effectiveness is limited. This payment structure constrains opportunities for new technology to be introduced since therapists and clinical staff do not have an immediate path for recuperating purchase costs for new equipment.
Value- and Evidence-Based Technology
Helping innovators identify these unforeseen commercial hurdles well in advance, and then plan for them, is a large part of TREAT’s work. The HRI and NCAN team now understands what their target users need. They are designing studies that will provide the data that physical and occupational therapists described as important to them in making the decision to incorporate the reflex-conditioning device in their clinics. Importantly, these studies will include commercially meaningful endpoints. HRI and NCAN will work on determining the required number of treatment sessions with consideration of insurance coverage parameters or how to demonstrate to insurers the need for lifting those session caps if Spinal Reflex Conditioning proves avoidance of costly future treatments. Giving thought to these elements at this early stage has reduced financial risk for purchasers and increased value for potential licensees or commercial enterprises.
Dr. Jon Lurie, Co-Director of TREAT and a Professor of Medicine and Orthopedics at the Geisel School of Medicine at Dartmouth says, “A major part of introducing a new therapy into today’s healthcare market includes demonstrating not only that it is safe and effective for regulatory purposes but also that it improves outcomes that are important to key stakeholders – those who are likely to recommend, use and/or pay for the technology – and that it provides greater or equal value compared to existing care.” With support from TREAT, Spinal Reflex Conditioning is moving out of the lab and into the clinic, reaching patients sooner.
About the Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT)
TREAT is part of the National Institutes of Health (NIH) Medical Rehabilitation Research Resource Network (MR3). Funding is provided by the National Center for Medical Rehabilitation Research (NCMRR) in the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) through awards R24HD065703 and P2CHD086841. For more, visit https://www.treatcenter.org/.
About Health Research, Inc. Technology Transfer – From Bench to Bedside
HRI has a long and distinguished history of recognizing, protecting and developing novel technologies. Successful transfers include a number of major medical technologies such as the prostate specific antigen (PSA) test, photodynamic cancer therapy, pox virus vectors, a diagnostic assay for HIV tropism, the blood thinner Angiomax, and the first effective antifungal agent Nystatin.
To learn more about collaborating with HRI or licensing technology for commercial applications contact:
Robert L. Gallo, Director – Intellectual Property & Licensing
About National Center for Adaptive Neurotechnologies (NCAN)
Medical University of South Carolina