EVREN TECHNOLOGIES, INC. — Department of Defense STTR Phase I: A21C-T024

Description

Transcutaneous auricular vagal nerve stimulation (taVNS) has been shown to effectively reduce stress responses in single day laboratory tests and could mitigate the negative performance effects associated with Acute Stress Reactions (ASR). taVNS can be accomplished with a small device designed to fit inside the ear and gently stimulate the vagus nerve. This treatment is non-invasive, inherently safe and does not result in significant cognitive, motor or other functional side effects. It acts rapidly to sustain Soldier performance and can be safely administered in operational environments as part of pre-hospital care. The technical objective of this Phase I STTR is to develop pilot data demonstrating the effectiveness of the Phoenix CR-100 in treating ASR shortly after occurrence. The Phoenix CR-100, a dual-purpose in-clinic and at-home taVNS stimulator, is being developed under an NIH grant (1R43MH125660-01) to advance taVNS through the development of more effective research tools.  In particular, the Phase I Technical Objectives of this STTR are: Aim 1: Evaluate the effectiveness of taVNS using the Phoenix CR-100 versus sham stimulation in treating ASR in a laboratory setting. The study will use personalized trauma scripts in a PTSD population to simulate the psychological and physiological effects of ASR. The primary outcome measures will be cognitive performance, reaction time, and indicators of sympathetic/parasympathetic response. Aim 2: Develop relationships with Army and DoD personnel interested in utilizing the system, jointly develop requirements for the Phase II device and create a plan for a Phase II clinical trial.  Our team has been studying acute stress like reactions in PTSD patients with the administration of personalized trauma scripts and have demonstrated that VNS can produce significant changes in sympathetic nervous system response and memory encoding capability compared to sham stimulation. Using this model of acute stress, we propose to demonstrate the effectiveness of taVNS in reducing the effects of ASR using measures of cognition and performance. If proven effective in mitigating ASR, Evren Technologies is ready to develop a ruggedized version of our device, the Phoenix CR-100 specifically for real world trials in ASR with military relevant performance metrics.