Vagus Nerve Stimulation as Treatment for Long Covid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Success
研究概览
简要总结
Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.
详细描述
Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation [application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had to have had COVID
- •Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.
排除标准
- •BMI > 30
结局指标
主要结局
Number of Participants With Treatment Success
时间窗: Baseline to post-treatment at 6-weeks
Treatment success is defined as patient had to improve on 2 of the following: a 14% improvement in SF-36 -- physical function (0-100 scale, higher score = less disability; report of marked or moderate improvement (2-3 on a scale going from +3 to -3\] based on the treatment \[patient global indication of change (0-7, higher score = more improvement); going from fatigue case to no fatigue on Chalder fatigue scale (0-3, higher score = more fatigue; improvement on VAS of at least 2 points \[VAS going from none \[0\] to 5 \[very severe\] with at least a 3 \[substantial\] on one of the following Sx --\> fatigue, brain fog, widespread pain
次要结局
- Number of Participants With Change in the Profile of Mood States (POMS)(6 weeks)
研究者
Benjamin Natelson
Professor of Neurology
Icahn School of Medicine at Mount Sinai