S. Hays, M. Powers, M. Kilgard, M. Douglas, J. Wigginton, M. Foreman, R. Rennaker
University of Texas at Dallas, Texas, United States
Keywords: Posttraumatic stress, prolonged exposure therapy, vagus nerve stimulation
Posttraumatic stress disorder (PTSD) is a major source of disability in veterans and active-duty military personnel. While some individuals with PTSD respond well existing treatments, many others fail to adequately respond, exhibit intolerable side effects, or relapse. PTSD exacts an outsized economic burden, reduces operational capabilities, and is linked to increased risk for suicidal ideation. The translation of an effective therapy is of clear importance. We have developed a novel therapy using vagus nerve stimulation (VNS) to treat chronic PTSD. Short bursts of VNS are delivered concurrent with prolonged exposure therapy (PE) in order to facilitate the benefits of this cognitive behavioral therapy. As part of a previous DARPA-funded project, we performed a Phase 1 early feasibility study (EFS) in individuals with chronic, treatment resistant PTSD that demonstrates that VNS therapy is safe, feasible to deliver, and substantially improves core symptoms. At the completion of therapy, 78% of individuals no longer met the criteria for PTSD, approximately double the rate of existing therapies. We are now performing a CDMRP-funded rigorous Phase 2a trial, and we are seeking partners to continue progress towards FDA approval and clinical delivery.