Vagus Nerve Simulation for Long-COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Composite Dysautonomia Symptom Score (COMPASS 31)
研究概览
简要总结
The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.
This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.
详细描述
Participants will be randomized into one of two arms. Those in the "active VNS" arm will be sent home with a portable VNS device and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for six weeks.
Those in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks. Those randomized to the sham group will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm (Week 12). The participant and assessor will be blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study will have a blinded assessor and all participants will be blinded.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •At least 18 years of age
- •Clinical diagnosis of dysautonomia following an acute COVID-19 infection at least 3 months prior. See below for criteria:
- •clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider
- •2 or more if the following clinical assessment findings
- •symptomatic exacerbation during active stand test
- •tachycardia on active stand test
- •tachycardia on orthostatic vitals assessment
- •hypotension on orthostatic vitals assessment
- •hypertension in orthostatic vitals assessment
- •symptom exacerbation on orthostatic vitals assessment
- •English speaking
排除标准
- •Pregnancy or lactation:
- •Pregnant persons will not be included in this study for the following reasons:
- •There is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (PCD). The results could be skewed due to pregnancy.
- •Of note, there are no risks for pregnant persons to participate.
- •According to the device manufacturer, the following contraindications will be followed during the screening process:
- •Patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device
- •Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years)
- •Patients with diagnosed bradycardia
- •Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- •Patients whose pain syndromes are undiagnosed
- •Pediatric patients
- •Pregnant women
结局指标
主要结局
Composite Dysautonomia Symptom Score (COMPASS 31)
时间窗: Week 12
COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.
次要结局
- Fatigue Severity Scale (FSS)(Week 12)
- Neuro Quality of Life Score(Week 12)
- Post-Exertional Malaise (PEM) Screener(Week 12)
- Plasma HS-CRP levels(Week 12)
- Medical Research Council (MRC) Dyspnoea Scale(Week 12)
- End-tidal CO2 levels(Week 12)
- EQ-5D-5L Quality of Life Score(Week 12)
- Plasma IL-6 levels(Week 12)
- Plasma IL-1 levels(Week 12)
- Plasma IL-10 levels(Week 12)
- Morning salivary cortisol levels(Week 12)
研究者
David Putrino
Director of Rehabilitation Innovation, Mount Sinai Health System Associate Professor of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai