Groundbreaking research has revealed a new method of potentially eliminating hard-to-treat post-traumatic stress disorder (PTSD) diagnoses in patients by employing a novel kind of therapy: stimulation of the vagus nerve.
The new treatment offers new hope for those long afflicted by PTSD diagnoses that have traditionally proven to be resistant to conventional treatment methods.
Scientists from the University of Texas at Dallas (UTD) and Baylor University Medical Center conducted the research, discovering that participants were symptom-free for up to six months after completing the experimental therapy.
The findings, published in the journal Brain Stimulation, represent the most comprehensive trial yet that employs an implanted device for PTSD treatment. The U.S. Defense Department’s (DoD) Defense Advanced Research Projects Agency (DARPA) funded the research.
A Novel Treatment for PTSD
The study’s Phase 1 trial involved nine participants with PTSD symptoms that had shown to be difficult to treat in the past. Each of the participants underwent prolonged exposure therapy, a form of cognitive behavioral therapy that allows patients to confront trauma-related memories and other potentially stressful stimuli safely.
In every session, short bursts of stimulation were administered to each patient’s vagus nerve using a small device implanted in their necks. Over the following six months, ongoing monitoring of all nine participants revealed that each remained in remission following the innovative therapy.
“In a trial like this, some subjects usually do get better, but rarely do they lose their PTSD diagnosis,” said Dr. Michael Kilgard, the Margaret Fonde Jonsson Professor of neuroscience at UTD.
“In this case, we had 100% loss of diagnosis,” Jonsson added. “It’s very promising.”
Rewiring the Brain
A core component of the study is its reliance on more than a decade of studies of neuroplasticity—the brain’s ability to “rewire” itself—conducted at UTD’s Texas Biomedical Device Center (TxBDC). Building on past research, the team was able to demonstrate that similar approaches helped treat patients with PTSD symptoms.
“The common theme in our VNS work is that we’re taking therapies that show potential, like prolonged exposure therapy for PTSD, and making them work better,” Kilgard said.
Kilgard also says that while PTSD is often associated with military veterans, many civilians also experience it as a result of extreme trauma. On average, around 5% of adults in the U.S. are affected by PTSD each year, based on information from the National Center for PTSD.
“When you hear PTSD, you may picture a combat zone, but it’s much more prevalent than that,” he said. “It can stem from any event that inspires fear of death or bodily injury, or death of a loved one.”
Another misperception is that PTSD most commonly affects the lives of men. However, according to current data, women are twice as likely to develop the condition. Further complicating treatment, many patients also experience relapse, side effects, or simply fail to respond to treatments that have been employed in recent decades, which leave them with few options for lasting recovery.
Implantable Technology
Fundamental to the new research was the team’s use of a dime-sized wireless implantable VNS device designed by UTD neuroscientist Dr. Robert Rennaker. The version the team employed for their recent study is roughly 50 times smaller than the initial prototype developed three years ago. In recent trials, no interference has been reported in standard medical imaging, such as MRIs or CT scans.
“The technology we have is above and beyond anything else that’s out there,” Rennaker said in a press release.
During the study’s second phase, which is presently underway, a placebo-controlled pilot study is being conducted in Dallas and Austin to build on the promising results of the study’s initial phase. If the second phase is successful, it could help the team secure approval from the FDA, which would expand the reach of the team’s new treatment, potentially making it available to a wider range of patients whose experiences with PTSD have proven to be difficult to treat in the past.
“Soon we could have the option of VNS for people who don’t get better with cognitive behavioral therapy alone,” said Dr. Mark Powers, co-corresponding author and director of the Trauma Research Center at Baylor Scott & White Research Institute. “VNS has changed the game by improving both treatment efficacy and its tolerability.”
“It’s been an incredibly rewarding experience to see this technology evolve from early discovery experiments in the lab to clinical benefits in patients,” said Dr. Seth Hays, associate professor of bioengineering at UTD.
“This whole process truly highlights the value of team-based science,” Hays said.
Micah Hanks is the Editor-in-Chief and Co-Founder of The Debrief. He can be reached by email at micah@thedebrief.org. Follow his work at micahhanks.com and on X: @MicahHanks.