Personalized tVNS device for research and treatment of PTSD

Project Summary/AbstractPost-Traumatic Stress Disorder (PTSD) afflicts as many as 8% of Americans and is growing rapidly, including a 400% increase in veterans receiving disability benefits for PTSD since 2005 and an expected uptick in cases for patients and clinicians from the COVID-19 pandemic. In the VA alone, the cost of treating veterans is over $15B. Unfortunately, treatments for PTSD are often ineffective, have side effects, and high rates of dropout. Transcutaneous Vagal Nerve Stimulation (tVNS) has shown promise in treatment of symptoms of PTSD but there are no commercially available tVNS devices that meet the needs of researchers to develop clinically usable solutions. Problems include device form factors (interface), dosing strategy, and the ability to adjust stimulation titration based on patient need. This project builds on our team’s early stage prototypes to create a clinical research tool that will accelerate the community’s (and our) ability to determine the most efficacious use of tVNS to improve quality of life for patients with PTSD.Current implementations of non-invasive vagal nerve stimulation do not meet patient or researcher needs for PTSD patients. Improved devices are needed to move this promising technology to a commercial product that is flexible, comfortable, portable, and effectively addresses the needs of this population. Clinician-scientists require a system which meets the complex needs for tVNS research, including high quality stimulation, programmable stimulation parameter control, and logging of physiologic response and patient usage; while also presenting a simple user interface for home use by patients.In this project we will develop Evren’s Phoenix Laboratory, which will be the first tVNS device able to meet these complex needs for both researchers and patients. In Phase I we will develop the stimulator and sensor hardware (Aim 1A) that serves both as the patient home-use system and also as the tethered researcher stimulator. Next we develop the PC-based researcher interface (Aim 1B) that provides the ability to fully optimize and configure the stimulator for clinical use, as well as securely integrate data from other systems and store/transfer the data into secure databases. Lastly, we will implement usability testing (Aim 2) with researchers and volunteers to obtain feedback on the performance and comfort of the system.Project Narrative Transcutaneous Vagus Nerve Stimulation (tVNS) has shown significant promise in reducing symptoms associated with PTSD. Since there are no commercially available tVNS devices with sufficient configurability for research development for clinical deployment, we will develop an easy to use tVNS device designed for researchers that enables translational research. These features are important for dosing trials and mechanistic work to optimize neurophysiological effects of this technology and successfully translate promising basic science work to clinical application.