Note the current publication of two collections of research papers related to work backed by the Reeve Foundation: The Journal of Neurosurgery: Spine
dedicates an entire supplement to the workings of the North American Clinical Trials Network for the Treatment of Spinal Cord Injury (NACTN for short); and the Archives of Physical Medicine and Rehabilitation
features 11 papers on the workings of the NeuroRecovery Network (NRN), the locomotor (treadmill) training program.
This burst of literature speaks to the fact that spinal cord injury research has matured to the point that clinical trials are being held, or planned, for several promising therapies. This, the era of translational research — moving from labs to clinics — requires new infrastructure to manage the process, and coordination of preclinical data, clinical assessment, treatment and outcome measures, and at some point, commercialization and reimbursement.
Both sets of papers are loaded with nuts and bolts and detail that one would not say is consumer-friendly; the authors seek to systematically deconstruct the processes and procedures of setting up and then running complex collaborative networks, and to validate the role of NACTN and NRN protocols as new therapies are measured against highly tuned and standardized metrics for effective outcome and recovery.
NACTN, created in 2004, is a consortium of university hospital neurosurgical and neurorehabilitation teams. NACTN’s lead investigator, neurosurgeon Robert G. Grossman, (Methodist Hospital, Houston), explains that given the complexity of SCI and the high cost of mounting clinical trials:
“There can be no progress without partnerships, without collaborations, without alliance-building. Spinal cord injury is too difficult and too expensive to go-it-alone and there is no room for failure due to ill-conceived planning or lack of cutting-edge spinal cord expertise.”
The NACTN literature series is an academic collaboration between the journal and AOSpine North America, an international community of spine surgeons, orthopedic surgeons, neurosurgeons, academics, researchers, and spine care professionals. There are 17 papers; five are termed systematic reviews, which means the authors scan available literature for things such as, what are the known clinical indicators of of a person’s eventual functional status. The answer: severity and level of injury along with age are pretty good predictors.
Obviously, patients and their families want a reliable guide to what’s ahead. Also, the trials network itself needs to have a good predictive tools to better classify patient sub-sets for tests of drugs or interventions. Says Michael Fehlings, the Toronto neurosurgeon who directed the NACTN supplement, “Our reviews on the clinical predictors of neurological outcome, functional status, survival after traumatic SCI, and prognosis for thoracic SCI — together with the clinical prediction model developed in our study of early versus late decompression after SCI — will provide the clinician with information to help communicate prognosis to patients and their families.”
Seven NACTN papers are clinical articles — for example, why the development of sensitive functional measures is so critical, or why it’s important to know what sorts of complications are common in acute cervical injuries.
The remaining papers in the collection are research articles. Two center on the drug riluzole, which is the first, and so far, only drug to move through NACTN, and which is headed for a Phase II continuation study next year.
is a national network of rehabilitative centers established by the Reeve Foundation to translate scientific advances into activity-based rehabilitation treatment for individuals with neurological disorders. The NRN is funded by a cooperative agreement between the Foundation and the U.S. Centers for Disease Control and Prevention (CDC).
The Archives literature includes 11 peer-reviewed studies; they conclude that establishing a network of centers with a standardized training program can lead to significant functional improvements for chronically injured patients with incomplete injuries. Findings are based on standardized data from 300 spinal cord injury patients at seven centers using measures of function, health, and quality of life. NRN teams include the varied perspectives of scientists, physicians, physical and occupational therapists, and hospital administrators.
The collection of papers emphasizes that the damaged nervous system has the potential for recovery but that recovery should be broadly define to embrace an individual's sense of accomplishment and well-being, as well as function.
The NRN papers (click here
for a rundown of all) include several articles explaining how the network is organized and managed, and how the work is pinned to research showing that the spinal cord itself, with proper sensory inputs, can control locomotion without brain contact.
Among the findings reported in the Archives:Locomotor Training benefitted people with spinal cord injury by increasing muscle strength in the legs by almost 25% and strength in the arms by 8%.
Completing Locomotor Training in the NRN produced large improvements in walking speed for 70% of participants with incomplete spinal cord injury.
Significant functional recovery can continue to occur even years after injury; intensive activity-based rehabilitation can result in functional improvements in individuals with chronic incomplete SCI.
One other paper came out regarding the kind of NRN results that one hopes an insurance company might use to justify the cost of training, this in the Journal of Neurologic Physical Therapy
. Two cases are presented, one of a four-year-old child and the other of an age 61 adult, showing that locomotor training improved both patients’ walking ability to the extent that they no longer needed major architectural renovations in their homes and no longer needed special adaptive transportation. The adult no longer needed wheelchair equipment. Bottom line, in terms of life care planning costs:
The four year old male had a decrease of expected lifetime expenses between $437,790 and $571,618 due to the gained function following the intense locomotor training intervention.
The 61 year old female had a decrease of expected lifetime expenses between $148,237 and $197,208 due to the gained function following the intense locomotor training intervention.