Summary: A groundbreaking clinical study revealed that combining vagus nerve stimulation (VNS) with standard therapy eradicated PTSD diagnoses in all participants for up to six months after treatment. This trial integrated prolonged exposure therapy with brief VNS bursts from an implanted device, promoting neuroplasticity and ensuring sustained remission.
Previous studies indicate that many individuals with PTSD don’t respond to conventional treatments, making this method particularly promising. Future research will delve deeper into this therapy, hoping to provide new solutions for those unresponsive to typical practices.
Key Facts:
- Complete Remission: Every participant was free of a PTSD diagnosis six months following the therapy with VNS.
- Enhanced Neuroplasticity: VNS supports brain rewiring, leading to better outcomes for patients resistant to traditional PTSD treatments.
- Future Directions: A double-blind Phase 2 trial is being conducted to affirm the findings and work towards FDA approval.
Source: UT Dallas
In a pioneering clinical study, researchers at The University of Texas at Dallas, along with Baylor University Medical Center, demonstrated that patients suffering from treatment-resistant PTSD were free of symptoms up to six months after undergoing traditional therapy combined with vagus nerve stimulation (VNS).
The findings from a nine-participant Phase 1 trial, conducted by the Texas Biomedical Device Center (TxBDC) at UT Dallas in partnership with the Baylor Scott & White Research Institute (BSWRI), were published online on March 15 in Brain Stimulation.
According to Dr. Michael Kilgard, the Margaret Fonde Jonsson Professor of neuroscience at the School of Behavioral and Brain Sciences, this outcome illustrates the potential of this innovative approach.
“In studies like this, some participants typically show improvement, but it’s rare for them to lose their PTSD diagnosis completely. Most will have it for life,” Kilgard noted. “Here, we saw a 100% loss of diagnosis. That’s incredibly hopeful.”
Prolonged exposure therapy, a key part of mainstream PTSD treatment, is a cognitive behavioral therapy method that allows individuals to gradually confront traumatic thoughts, memories, and situations in a safe environment.
In this study, researchers combined this therapy with short bursts of stimulation delivered to the vagus nerve via a device implanted in the neck of the participants.
Following a standardized 12-session therapy regimen, assessments were conducted four times during the six months post-treatment, showing sustained benefits for all nine participants.
This trial stands out as the largest clinical effort to date utilizing an implanted device for PTSD treatment, according to Kilgard.
Research from TxBDC has shown that VNS combined with physical rehabilitation can hasten neuroplasticity—the process of rewiring the brain.
Their 13-year research initiative aimed at treating various conditions with VNS has led to FDA approval for improving upper-limb movement in stroke victims.
“Our VNS work consistently shows that we can enhance therapies with potential, such as prolonged exposure therapy for PTSD,” he mentioned.
The National Center for PTSD, from the Department of Veterans Affairs, estimates that 5% of U.S. adults experience post-traumatic stress disorder each year, with women being twice as likely to develop it during their lifetime.
Unfortunately, many PTSD sufferers do not respond well to existing therapies or medications, often facing severe side effects, leaving them without effective pathways to recovery.
Kilgard emphasized that PTSD isn’t just confined to military veterans; everyday people can also be affected by traumatic events.
“When people think of PTSD, they often picture combat scenarios, but it is actually much more widespread,” he remarked. “It can arise from any situation that triggers a fear of death or serious injury, or the loss of a loved one.”
Co-corresponding author Dr. Seth Hays, who serves as an associate professor of bioengineering and director of preclinical research at TxBDC, has been involved with the VNS project since its inception.
“It’s incredibly gratifying to witness this technology transition from early laboratory discoveries to real-world patient benefits,” Hays commented, emphasizing the importance of collaborative science.
More than ten years back, Dr. Robert Rennaker, a neuroscience professor and the Texas Instruments Distinguished Chair in Bioengineering, initiated the design of a smaller and more affordable implantable VNS device. The latest wireless model is about the size of a dime.
“Our device technology surpasses anything currently available. It’s around 50 times smaller than our version from just three years ago,” he added.
“The 49 people in the Dallas area using our devices have accumulated a collective 100 years of experience with them. There have been no issues; the devices are all still operational and do not interfere with standard medical care, including MRIs, CT scans, or ultrasounds.”
The next phase of PTSD research— a double-blind, placebo-controlled Phase 2 pilot study—is currently underway in Dallas and Austin.
“We hope this will mark another stride toward FDA approval for a treatment that is currently unavailable, invented, tested, and implemented by UT Dallas, similar to the upper-limb recovery tech after stroke,” Kilgard stated.
Dr. Mark Powers, a licensed clinical psychologist and director of the Trauma Research Center at BSWRI, is the lead and co-corresponding author of the study.
Motivated by the desire to enhance the quality of life for those who deal with psychological trauma, Powers asserted that VNS represents a significant advancement by enhancing both effectiveness and tolerability of treatments.
“VNS has drastically transformed my work,” he said.
“The best treatments we have for PTSD yield about an 85% response rate, with 40% completely losing their diagnosis, alongside a 20% dropout rate. Soon, VNS could provide options for those who don’t improve with cognitive behavioral therapy alone.”
Powers highlighted the synergy achieved through collaboration with UTD, categorizing it as a unique multidisciplinary effort.
“This partnership allows for simultaneous preclinical and clinical work that fosters feedback and fresh ideas,” he added. “Neither team could achieve this independently.”
Other authors affiliated with UTD include Dr. Jane Wigginton, medical director and co-director of the UT Dallas Clinical and Translational Research Center; Amy Porter, director of operations at TxBDC; and Holle Carey Gallaway, a research biomedical engineer at TxBDC.
Researchers from Southern Methodist University, UT Austin, and Baylor Scott & White Health also contributed to the study.
Funding: The research received a grant (N66001-15-2-4057) from the Biological Technologies Office at the Defense Advanced Research Projects Agency, part of the Department of Defense.
