The U.S. Department of Defense granted a four-year, $3 million funding to a research group at Florida State University College of Medicine to initiate a clinical trial on a potential treatment for post-traumatic stress disorder — marking the second DoD grant for the FSU clinical neuroscience team led by Dr. F. Andrew Kozel alongside co-director Kevin A. Johnson.
The treatment integrates virtual reality into the team’s already promising research involving transcranial magnetic stimulation (TMS) therapies. TMS employs magnetic fields to activate nerve cells in targeted regions of the brain. In this novel clinical trial, participants diagnosed with PTSD will first partake in two weeks of virtual reality mindfulness exercises twice daily.
“If at that juncture their symptoms have not alleviated, they will enter a protocol where they are randomized to either active or sham — or genuine versus placebo — accelerated TMS,” explained Kozel.
Participants involved in the TMS aspect of the research are randomized into three distinct groups. Two groups will receive active TMS targeting different brain areas, whereas the third group will receive a sham treatment. Ultimately, all participants will undergo an active accelerated TMS regimen. Consequently, every participant will experience at least one active TMS treatment throughout the study.
The treatments are “accelerated” in that, rather than adhering to the usual clinical protocol of one session each weekday for around six weeks, this fresh clinical trial requires volunteers to attend for just five consecutive days, receiving five treatments daily.
“Our objective is to ascertain whether accelerated TMS serves as an effective intervention for PTSD,” said Kozel. “This study will also provide us with valuable insights into which treatment parameters may prove more effective and the duration of their effects. One significant issue with numerous treatments is that they may demonstrate initial efficacy but then diminish swiftly. TMS therapies for depression traditionally exhibit sustained effects — often lasting years. This still requires investigation for accelerated TMS to determine if the same applies to PTSD.”
To evaluate long-lasting effects, researchers will follow up with participants at one, three, and six months intervals.
Kozel and Johnson indicate that PTSD can stem from any traumatic incident.
“PTSD manifests in various forms,” stated Johnson, who holds a doctorate in neuroscience and is also a licensed nurse. “It can arise from military conflict, car accidents, violent crimes, domestic violence — and numerous other situations.”
While there is a modest financial compensation for eligible participants who finish the trial, Johnson noted that this is not the primary motivator for individuals to take part.
“Part of the reason could be that they may feel they lack alternative treatment options. Not every individual will improve with research therapies. We will see a specific percentage that does, but even among those who do not experience improvement, they understand that we are gaining knowledge through the process, and they are aiding in supporting the wider community,” he remarked. “They recognize the extent of their struggles with PTSD, and even if this does not provide the right solution for them, they are aware that they are assisting us in uncovering the correct solutions for others.”
Those who are keen to engage in research at FSU Neuromodulation can navigate to the lab’s website med.fsu.edu/kozellab/fsu-neuromodulation to fill out a confidential contact survey.
The article Promising PTSD research gets boost with Department of Defense grant originally appeared on Florida State University News.