USF Health welcomed its first participants of a $28 million state-funded clinical trial to study the effectiveness of hyperbaric oxygen therapy on Florida service members and veterans who suffer from traumatic brain injury. The scope of this ambitious project is recognized nationally as one of the most rigorous studies of its kind with long-term results that could reshape the narrative of hyperbaric oxygen therapy as a treatment of neurological diseases.
The five-year, randomized, double-blind, placebo-controlled study, led by the USF Health Department of Neurosurgery and Brain Repair, is taking place in the state-of-the-art Hyperbaric Oxygen Therapy Center, which completed construction earlier this fall. Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized environment to fill the blood with enough oxygen that allows tissues to repair. Participants will go through a four-month cycle in which their blood, oxygen, brain levels and a multitude of physiological signs are closely monitored and recorded. Participants who receive the placebo will be offered the option to be treated with hyperbaric oxygen at the end of their study cycle.
The clinical trial was championed by Florida House Speaker Paul Renner, who recently visited the newly-built USF Health HBOT Center. A retired Naval officer, Renner has been a strong supporter of hyperbaric oxygen therapy as a potential treatment for conditions, such as TBI. After receiving positive feedback from numerous service members who have used HBOT, he advocated for a large-scale trial to learn more about the therapy’s potential benefits and believed USF Health was best positioned to lead that effort.
“I had a great meeting with the scientists behind the study and I couldn’t be more excited about their comprehensive scientific approach that will hopefully allow us to make some definitive statements about the efficacy of this treatment for our veterans,” Renner said. “We will discover things that can also help people out in the general community. That is what’s so exciting about the depth and breadth of this kind of study.”
Florida House Speaker Paul Renner (left) receiving a briefing from Harry van Loveren, MD, and Joseph Dituri, PhD.
Principal investigator Harry van Loveren, MD, chair of the USF Health Department of Neurosurgery and Brain Repair, leads a team of more than 30 experts who have spent decades on TBI-focused research. They have produced nearly 100 peer-reviewed journal articles and conducted numerous smaller state-funded clinical trials. USF Health’s longstanding excellence in TBI-related research was one of many factors why Renner was inspired to advocate for the study to be funded in the state budget.
“Through this opportunity from the state of Florida, we have created multiple studies within the larger study, and we feel it is our duty to maximize the return in the research investment made to the Morsani College of Medicine. Even if hyperbaric oxygen does not show efficacy for TBI in veterans, we will publish the results and explore potential other therapies to help those that served our country,” Dr. van Loveren said. “It’s exciting that the state of Florida is supporting such an important multi-faceted research endeavor and we are thrilled to share the progress and outcomes.”
Those involved believe the study has taken on the theme of “veterans helping veterans,” Dr. van Loveren said. “It’s an opportunity for veterans to serve their country on behalf of their fellow veterans one more time.”
Joseph Dituri, PhD, a retired Naval diving officer and assistant vice president for Veteran’s Clinical Research at USF, serves as the safety director of the USF Health HBOT Center. His team of five, all veterans, are the primary points of contact for participants during their visits. Dr. Dituri, who set the world record for living underwater last year, says he’s excited for the prospect providing a firm scientific grounding to the current anecdotal evidence surrounding hyperbaric oxygen.
“Science wins over conjecture at the end of the day,” Dr. Dituri said.
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Interested potential active-duty service members or veterans can learn more about the HBOT trial by visiting hbot.usf.edu and completing a brief form.