Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Post-COVID Functional Status Score
研究概览
简要总结
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.
详细描述
Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of fatigue and post exertional malaise.
- •Presence of headache
- •Clinical diagnosis of post COVID syndrome.
- •They have consented to participate in the study
- •They have the ability to participate in all aspects of the study.
排除标准
- •Pregnant.
- •Prior adverse reaction to 14FDG.
- •Active implantable medical device e.g. pacemaker, hearing aid implant
- •Metallic device e.g. stent, orthopedic hardware in neck
- •Using another electronic device at the same time e.g. TENS, mobile phone.
- •Any other condition deemed exclusionary by the study principal investigator
研究组 & 干预措施
VNS Treatment
Subjects with post COVID syndrome with fatigue and headache will have vagal nerve stimulator applied to the neck for 2 minute intervals with two sets administered three times daily
干预措施: vagal nerve stimulator (Device)
Non-VNS Treatment
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
结局指标
主要结局
Change in Post-COVID Functional Status Score
时间窗: Baseline to 12 weeks
Measurement is the change in scoring determined through patients' self-reported Post-COVID Functional Status Score survey, which assesses COVID-19 symptom impact on a grading scale of 0 = no limitations to 4 = severe limitations. Thus, higher scores are a worse outcome, and a change indicating an increase is a worsening of functional status.
次要结局
- Change in PROMIS Fatigue Scale T Score(Baseline to 12 weeks)
研究者
Ryan T. Hurt, M.D., Ph.D.
Principal Investigator
Mayo Clinic