PhD Candidate, Dulin Lab, Texas A&M University Department of Biology
Fighting for Recovery on Multiple Fronts: The Past, Present, and Future of Clinical Trials for Spinal Cord Injury
Valerie A. Dietz (1), Nolan Roberts (1), Katelyn Knox (1), Sherilynne Moore (1), Michael Pitonak(1), Chris Barr (2), Jesus Centeno (2), Allison Leatherman (2), Scott Leininger (2), Kent New (2), Peter Nowell (2), Matthew Rodreick (2), Cedric G. Geoffroy (3,4), Argyrios Stampas (5), Jennifer N. Dulin (1,4)
(1) Department of Biology, Texas A&M University, College Station, TX 77843
(2) Unite 2 Fight Paralysis, Minneapolis, MN 55403
(3) Department of Neuroscience and Experimental Therapeutics, Texas A&M University, College Station, TX 77843
(4) Texas A&M Institute for Neuroscience, Texas A&M University, College Station, TX 77843
(5) Department of Physical Medicine and Rehabilitation, UTHealth Houston McGovern Medical School, Houston, TX, 77030
Through decades of preclinical research, great progress has been achieved in understanding the complex nature of spinal cord injury (SCI), and preclinical research efforts are continually focused on developing and optimizing effective therapies to improve the quality of life for individuals living with SCI. Preclinical discoveries have ultimately guided and shaped clinical trials, which are growing in number by the year. However, despite tremendous effort by scientists and physicians, no singular treatment has been generated for SCI. In order to understand where the limiting factor lies, we performed a meta-analysis of all the clinical trials registered in the U.S. National Library of Medicine (ClinicalTrials.gov) focused on improving outcomes after SCI. Using publicly accessible data downloaded from the ClinicalTrials.gov database, we reviewed 1149 interventional SCI clinical trials by classifing each trial according to the types of interventions being tested and outcome measures. With regard to clinical trial attributes, we found that most trials have low enrollment, only test single interventions, and have limited numbers of primary outcomes. Some gaps in reporting are apparent; for instance, 80% of clinical trials with “Completed” status do not have results posted, and the Phase of some trials is incorrectly classified as “Not applicable” despite testing a drug or biological compound. When analyzing trials based on types of interventions assessed, we identified the largest representation in trials testing rehab/training/exercise, neuromodulation, and behavioral modifications. Most represented primary outcomes include motor function of the upper and lower extremities, safety, and pain. The most overrepresented secondary outcomes include quality of life and pain. Over the past 15 years, we identified increased representation of neuromodulation and rehab trials, and decreased representation of drug trials. Together, our work provides a comprehensive glimpse into the past, present, and future of SCI clinical trials, and suggests areas for improvement in clinical trial reporting.
Valerie Dietz is a PhD candidate in the laboratory of Dr. Jennifer Dulin in the Texas A&M University Department of Biology. Valerie graduated in 2018 from Texas A&M with her BS in Biology, where she began research as an undergraduate student. During her graduate studies, she has worked on a project characterizing anatomical correlates of neuropathic pain in a spinal cord contusion injury model, published this year in Experimental Neurology. She is now working on a project to characterize how regional identity influences synaptic integration of neural progenitor cell grafts into the injured spinal cord. In addition to doing bench work, Valerie has found a passion for understanding how lab work translates into clinical settings, which served as inspiration for the meta-analysis of all clinical trials that have been conducted in SCI research thus far. She is passionate about patient advocacy and hoping to continue her career in this area.