Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Score of Patient Health Questionnaire-9
研究概览
简要总结
The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID positive
- •Depression
- •Headaches
- •Irritability
- •Cognitive Processing
排除标准
- •Damage to left ear anatomy
- •Unstable hemodynamic effects
- •Ischemic or hemorrhagic stroke after developing COVID
- •Unable to give consent, follow instructions
- •Unable to read or write or speak English
- •No access to home WiFi
结局指标
主要结局
Change in Score of Patient Health Questionnaire-9
时间窗: Baseline and week 4 (End of Treatment)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score \< 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.
次要结局
未报告次要终点
研究者
Mark S. George , MD
Distinguished University Professor
Medical University of South Carolina