Randomized Trial of Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Spectral analysis of heart rate variability
研究概览
简要总结
The tVNS-PP trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on autonomic functions, immune responses, and disease severity in chronic pain and restless legs syndrome (RLS) patients as compared to healthy controls.
详细描述
A pilot study with healthy participants will investigate whether transcutaneous vagus nerve stimulation at the inner tragus reduces heart rate variability and lowers blood pressure without causing undesirable, severe side effects. In addition, changes in immune markers will be analyzed in blood samples before and after the interventions. Patients with primary restless legs syndrome will undergo a similar experimental protocol, except that transcutaneous vagus nerve stimulation will be performed daily. The aim is to determine whether stimulation reduces disease severity and chronic pain while improving quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants between 18 and 80 years old
- •Written informed consent
排除标准
- •Age younger than 18 years or older than 80 years
- •Participants with somatic or mental comorbidities, especially malignant tumor diseases, cardiac insufficiencies > NYHA II, severe depressive episodes, psychosis or dementia
- •Pregnancy or breast feeding
- •Addictions to alcohol, medications or drugs (except tobacco)
- •An existing legal guardianship
- •Participation in another scientific study within the previous eight weeks before enrollment
- •Restless Legs Syndrome patients with one of the following secondary predispositions: iron deficiency, polyneuropathy, prolapsed disk, spinal stenosis or chronic obstructive pulmonary disease
结局指标
主要结局
Spectral analysis of heart rate variability
时间窗: Two days
The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage.
Spontaneous baroreceptor sensitivity
时间窗: Two days
The average baroreceptor sensitivity in ms/mmHg.
Time domain analysis of heart rate variability
时间窗: Two days
The standard deviation of the RR intervals (SDNN) and the root mean square of successive differences (RMSSD) in milliseconds.
International RLS Severity Scale
时间窗: Seven days
Numeric score quantifying disease severity. This numeric rating scale ranges from 0 to 40 points. The higher the achieved score, the higher is the RLS disease severity. 0 points: no symptoms, 1-10 points: mild symptoms, 11-20 points: moderate symptoms, 21-30 points: severe symptoms, 31-40 points: extreme symptoms
次要结局
- Hospital Anxiety and Depression scale(Two days)
- Median nerve stimulation(Two days)
- Brief Pain Inventory(Two days)
- Serum cytokine concentrations(Two days)
- Sudoscan(Two days)
- Short Form 12 (SF-12)(Two days)
研究者
Prof. Thomas Meyer
Head of Laboratory
University Medical Center Goettingen