Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
Abstract
Post-traumatic stress disorder (PTSD) is a common source of service-connected disability. Although current treatments can help some people, many others do not benefit or experience intolerable side effects. Providing consistent, effective relief for individuals with PTSD is of clear importance to our Service Members and Veterans. This project builds on our initial success toward developing a novel therapy to treat chronic PTSD. Our approach uses electrical stimulation of a nerve in the neck to promote rewiring of specific cells in the brain and to activate the calming rest-and-digest response. Combining this nerve stimulation with prolonged exposure (PE), a common type of behavioral therapy, serves to potentiate the benefits of PE and thereby reduce the symptoms of PTSD. Our research in animal models shows the potential of this nerve stimulation therapy. Building on these studies, we have begun a first-in-human trial to test this intervention in individuals with chronic PTSD. Preliminary findings show that the therapy is safe, tolerable, and reduces core symptoms in individuals with treatment-resistant PTSD. The remaining steps to bring this therapy to clinical practice are completion of successful phase 2 and 3 studies. Here, we propose an expeditious effort to accomplish the first of these goals and lay the foundation to complete the second. In this project, we will perform a rigorous phase 2 clinical study to investigate whether the therapy improves recovery in individuals with chronic PTSD. Additionally, we will determine the most effective way to deliver therapy in order to maximize benefits. Finally, we will begin the steps needed to smoothly transition to a subsequent phase 3 study once the proposed project is completed. We will leverage the expertise of our community- based lived experience consultant throughout the study to gain perspective on recruitment, implementation, and future application of our therapy. Our group is seriously committed to developing new and improved treatments for neurological disorders. We have successfully converted a similar approach into the first FDA-approved treatment for chronic stroke. The project proposed here will lead directly to a Phase 3 pivotal study for chronic treatment-resistant PTSD, which is a necessary step toward eventual clinical use. Ultimately, these efforts are focused on translating this innovative therapy to yield real, tangible benefits for Service Members, Veterans, and their families.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310818
Entities
People
- Seth A Hays
Organizations
- United States Army
- University of Texas at Dallas