Personalized tVNS device for research and treatment of PTSD

用于研究和治疗 PTSD 的个性化 tVNS 设备

• 批准号: 10156243
• 负责人: Neil R. Euliano
• 金额: $ 25.66万
• 依托单位: EVREN TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-05 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10156243
• 关键词: Address; American; Anxiety; Anxiety Disorders; Basic Science; COVID-19 pandemic; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Trials; Communities; Complex; Computer software; Data; Databases; Device Designs; Device or Instrument Development; Devices; Dose; Dropout; Ear; Emotional; Ensure; Evaluation; Exposure to; Feedback; Financial Hardship; Financial compensation; Frequencies; Fright; Gold; Home; Injury; Knowledge; Laboratories; Learning; Mental disorders; Nerve; Participant; Patients; Performance; Pharmacology; Pharmacotherapy; Phase; Physiologic Monitoring; Physiologic pulse; Physiological; Population; Post-Traumatic Stress Disorders; Prevalence; Psychotherapy; Quality of life; Relapse; Research; Research Personnel; Safety; Scientist; Secure; Severities; Societies; Stress; Symptoms; System; Technology; Testing; Titrations; Translating; Translational Research; Trauma; United States; United States Department of Veterans Affairs; Veterans; Visual Aid; Width; Work; associated symptom; base; behavioral health; clinical application; clinical development; clinical practice; cost; data exchange; disability; experience; flexibility; improved; innovation; memory process; miniaturize; neurophysiology; non-invasive system; portability; programs; prototype; psychologic; reduce symptoms; research and development; response; sensor; sexual violence; side effect; signal processing; social; stressor; symptom cluster; symptom treatment; tool; usability; vagus nerve stimulation; volunteer

Project Summary/Abstract Post-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.

项目总结/文摘