Author: M B Powers1, Hays Sa2, Rosenfield D3, Porter Al4, Gallaway Hl4, Chauvette Gv5, Smits Jaj6, A M Warren5, Douglas M5, R Naftalis7, Wigginton Jg4, Foreman M7, Kilgard Mp8, Rennaker Rl8
Affiliation:
1 Baylor Scott & White Research Institute, Dallas, TX 75246 USA. Electronic address: mark.powers1@bswhealth.org.
2 Department of Bioengineering, Erik Jonsson School of Engineering and Computer Science, University of Texas at Dallas, Richardson, TX 75080 USA; Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX 75080 USA. Electronic address: seth.hays@utdallas.edu.
3 Department of Psychology, Southern Methodist University, Dallas, TX 75275, USA.
4 Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX 75080 USA.
5 Baylor Scott & White Research Institute, Dallas, TX 75246 USA.
6 Department of Psychology and Institute for Mental Health Research, The University of Texas at Austin, Austin, TX 78712, USA.
7 Department of Surgery, Baylor Scott & White Health, Dallas, TX 75246 USA.
8 Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX 75080 USA; Department of Neuroscience, School of Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX 75080 USA.
Conference/Journal: Brain Stimul
Date published: 2025 Mar 15
Other:
Pages: S1935-861X(25)00060-9 , Special Notes: doi: 10.1016/j.brs.2025.03.007. , Word Count: 244
Background:
Posttraumatic stress disorder (PTSD) is common and debilitating, and many individuals do not respond to existing therapies. We developed a fundamentally novel neuromodulation-based therapy for treatment-resistant PTSD. This approach is premised on coupling prolonged exposure therapy, a first-line evidence-based cognitive behavioral therapy that directs changes within fear networks, with concurrent delivery of short bursts of vagus nerve stimulation (VNS), which enhance synaptic plasticity.
Methods:
We performed a first-in-human prospective open-label early feasibility study (EFS) using a next-generation miniaturized system to deliver VNS therapy in nine individuals with moderate to severe treatment-resistant PTSD. All individuals received a standard 12-session course of prolonged exposure therapy combined with VNS. Assessments were performed before, 1 week after, and 1, 3, and 6 months after the completion of therapy.
Clinicaltrials:
gov registration: NCT04064762.
Results:
VNS therapy resulted in significant, clinically-meaningful improvements in multiple metrics of PTSD symptoms and severity compared to baseline (CAPS-5, PCL-5, and HADS all p < 0.001 after therapy). These benefits persisted at 6 months after the cessation of therapy, suggesting lasting improvements. All participants showed loss of PTSD diagnosis after completing treatment. No serious or unexpected device-related adverse events were observed.
Conclusions:
These findings provide a demonstration of the safety and feasibility of VNS therapy for PTSD and highlight the potential of this approach. Collectively, these support the validation of VNS therapy for PTSD in a rigorous randomized controlled trial.
Keywords: Cognitive Behavioral Therapy; Posttraumatic Stress Disorder; Prolonged Exposure Therapy; Vagal Nerve Stimulation; Vagus Nerve Stimulation.
PMID: 40097094 DOI: 10.1016/j.brs.2025.03.007
