USF Health has commenced a state-funded clinical trial, backed by $28 million, to investigate the therapeutic potential of hyperbaric oxygen therapy (HBOT) for Florida service members and veterans suffering from traumatic brain injury (TBI). The study, recognized as one of the most rigorous of its kind, aims to provide long-term results that could redefine HBOT's role in treating neurological diseases.
The five-year, randomized, double-blind, placebo-controlled trial is being conducted at the newly established Hyperbaric Oxygen Therapy Center. Participants will undergo a four-month cycle involving pure oxygen breathing in a pressurized environment, with continuous monitoring of blood oxygen levels, brain activity, and other physiological indicators. Individuals in the placebo group will have the option to receive HBOT treatment after completing their participation.
State Support and Veteran Advocacy
Florida House Speaker Paul Renner, a retired Naval officer, has been a key advocate for the trial, citing positive feedback from service members who have previously used HBOT. Renner emphasized the importance of a large-scale study to rigorously assess the therapy's potential benefits. "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 stated.
USF Health's Expertise in TBI Research
The trial is led by principal investigator Dr. Harry van Loveren, chair of the USF Health Department of Neurosurgery and Brain Repair, along with a team of over 30 experts. USF Health's extensive experience in TBI research, including nearly 100 peer-reviewed publications and previous state-funded clinical trials, was a significant factor in securing funding for the study. "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," said Dr. van Loveren.
Study Design and Objectives
The study's primary objective is to determine the efficacy of HBOT in treating TBI in veterans. Researchers will closely monitor various physiological parameters and cognitive outcomes to assess the therapy's impact. The double-blind, placebo-controlled design ensures objectivity in evaluating the results. The trial also embodies a theme of "veterans helping veterans," with a team of veteran staff members providing support and guidance to participants.
Addressing Anecdotal Evidence with Scientific Rigor
Dr. Joseph Dituri, 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. He highlighted the importance of grounding anecdotal evidence with firm scientific data. "Science wins over conjecture at the end of the day," Dr. Dituri said.
