6 NSU CLINICAL TRIAL AND LICENSING OPPORTUNITIES Room to Breathe Starting out in an amyotrophic lateral sclerosis (ALS) clinic as a University of South Florida student in Tampa, Florida, Lauren Tabor Gray, Ph.D., CCC-SLP, noted a lack of interventions. Loss of breathing and inability to clear the airway are the leading causes of death among ALS patients, yet “We had absolutely nothing to offer these patients as a speech pathologist or respiratory therapist,” Tabor Gray said. The modus operandi was to wait until breathing became bad and then use an exterior breathing device, such as a noninvasive volume ventilator. Patients with less fragile diseases like Parkinson’s disease have benefited from exercise programs and Lee Silverman Voice Treatment (LSVT) for decades. During her doctoral studies, Tabor Gray mentored under the first clinical researcher to investigate early intervention respiratory training in ALS, Emily Plowman, Ph.D. The pursuit became the focus of her doctoral degree work in neurorehabilitation. In her own line of research, she further investigated exercise-based respiratory interventions that are implemented early in the disease to improve function over time and to mitigate the loss of critical breathing and swallowing functions. Last year, her lifelong dedication to ALS patients led her to NSU. NSU boasts the largest speech-language pathology master’s degree program in the country, she noted. The juxtaposition in resources for academics and research opened new doors and paved the way to securing larger grants that can help ALS and other patient populations as well. “My team and I have received smaller foundation grants in the past, but we needed an administrative research team to help collate all the ancillary documents needed to secure our first U.S. Department of Defense grant,” Tabor Gray said. “At NSU, everyone rallies behind you.” Attending the NSU Grant Lab Chat sessions opened Tabor Gray’s eyes to “all the things that were possible and the people poised to help connect the silos that can exist within a university.” She also leveraged NSU’s grant writing assistance and carved out time for research writing thanks to the support of leadership at the NSU Health Neuroscience Institute. When research implications extend beyond the lab, NSU’s Office of Clinical Research steps in to help. Our experts support investigative teams through standardized procedures and regulatory and operational assistance. Best practices ensure participant safety as NSU advances human health through clinical trials. One bonus? Faculty members from across the university can collaborate with these centralized colleagues whose own bodies of work are impressive. Here are two stories to that point. The primary question of the new grant is whether an early intervention can be implemented that combines lung volume recruitment and expiratory muscle strength training to improve breathing, airway protection, and clearance in patients. “The study fills a very important gap in current literature,” Tabor Gray added. We need to know if professionals can intervene early and if such interventions change the trajectory of decline in the short term, with longer-term outcome implications. Among the other grant facets is the ability to work with a respiratory physiotherapist in Melbourne, Australia, who has been performing a standard of care for ALS patients that has not yet been introduced in the United States. For Tabor Gray’s purposes, the team is using FDA-approved devices that have just never been combined with ALS treatment in this country. “What I like about clinical research is that you can implement it pretty directly,” Tabor Gray said. “There are not a lot of steps in between what we are doing in this grant and what we are able to use in a clinic with an actual patient.”
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