In a groundbreaking clinical trial, scientists from The University of Texas at Dallas and Baylor University Medical Center found that patients with treatment-resistant PTSD remained symptom-free for up to six months after completing traditional therapy combined with vagus nerve stimulation (VNS).

Results from the Phase 1 trial, which included nine participants, were published online March 15 in Brain Stimulation. The study was led by researchers at UT Dallas’ Texas Biomedical Device Center (TxBDC) in partnership with the Baylor Scott & White Research Institute (BSWRI).

Dr. Michael Kilgard, the Margaret Fonde Jonsson Professor of Neuroscience, emphasized the significance of the results. “In trials like this, it’s rare to see complete loss of PTSD diagnosis, but here, every participant no longer met the criteria for PTSD. That’s extremely promising,” he said.

The therapy involved prolonged exposure a form of cognitive behavioral therapy that gradually helps patients confront trauma-related thoughts and situations paired with timed bursts of electrical stimulation delivered to the vagus nerve via a small implanted device. All nine participants completed 12 sessions, and follow-up assessments over six months confirmed lasting benefits.

According to Kilgard, this is the largest clinical study to date using an implanted device to treat PTSD. Prior research at TxBDC has shown that VNS can accelerate neuroplasticity when paired with rehabilitation, leading to FDA-approved treatments for post-stroke upper-limb recovery.

“We’re enhancing existing therapies like prolonged exposure by making them more effective with VNS,” Kilgard said.

The National Center for PTSD reports that around 5% of U.S. adults suffer from the condition annually, with women being twice as likely to be affected. Many patients don’t respond to existing treatments or suffer side effects, leaving few effective options.

Kilgard noted that PTSD affects not only veterans but also civilians exposed to traumatic events. “PTSD can result from any situation that involves serious threat or loss not just combat,” he said.

Dr. Seth Hays, co-corresponding author and director of preclinical research at TxBDC, highlighted the long journey of the VNS project. “It’s been incredibly fulfilling to see this technology go from lab discovery to improving lives in clinical settings.”

The current device, designed by Dr. Robert Rennaker, is about the size of a dime and is significantly smaller and more affordable than earlier versions. The latest model is wireless and compatible with standard medical imaging, with no reported device failures among users.

A double-blind, placebo-controlled Phase 2 trial is now underway in Dallas and Austin, aiming to bring this innovative therapy closer to FDA approval.

Source: https://www.sciencedaily.com/releases/2025/05/250505170641.htm