Effects of Chronic Non-invasive Vagus Nerve Stimulation in an Asplenic Individual Suffering From Rheumatoid Arthritis
Effects of Non-Invasive Vagus Nerve Stimulation on Rheumatoid Arthritis: A Longitudinal Prospective Case Study.
The goal of this clinical trial is to learn if chronic self-administrated non-invasive vagus nerve stimulation works to improves the disease activity in a single asplenic patient suffering from rheumatoid arthritis. It will also learn about the safety of at-home chronic non-invasive vagus nerve stimulation. The main questions it aims to answer are:
Does chronic non-invasive vagus nerve stimulation improves the disease activity? Does chronic non-invasive vagus nerve stimulation decrease CRP serum level? Does chronic non-invasive vagus nerve stimulation improve HRV and the sympathy-vagal balance?
Participant will:
Stimulate at home the left auricular branch of the vagus nerve for 24 months with three different protocol of stimulation (parameters and duration) Visit the clinic once every 2 months for checkups and tests Will have blood work for CRP level check every 8 months
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Brunswick
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Moncton、New Brunswick、加拿大、E1C 5N3
- OsteoFlow Health Clinic
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- diagnosed RA
- splenectomy
Exclusion Criteria:
Pharmaceutical treatment as:
- disease-modifying antirheumatic drugs (DMARDs)
- Biologics
- Jak inhibitors
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：n-of-1
|
24 months self-administrated trans-auricular vagus nerve stimulation in an asplenic patient.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis
大体时间：From enrollment to the end of treatment at 24 months
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the Simple Disease Activity Index (SDAI) for Rheumatoid Arthritis is measured using the online MDCalc (https://www.mdcalc.com/calc/2194/simple-disease-activity-index-sdai-rheumatoid-arthritis)
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From enrollment to the end of treatment at 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the sympathovagal balance
大体时间：From enrollment to the end of treatment at 24-month
|
the sympathovagal balance is calculated using the ratio of the power in normalized units of LF/HF.
The analysis is processed with Kubios HRV Premium 3.5.0
software
|
From enrollment to the end of treatment at 24-month
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Neuro-immunological (NIM) Index
大体时间：From enrollment to the end of treatment at 24-month
|
the neuro-immunological index express the effect of vagal modulation on inflammation and is the ratio of RMSSD / CRP
|
From enrollment to the end of treatment at 24-month
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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