Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Subjective Rating of Symptoms at 2 Weeks
研究概览
简要总结
The goal of this clinical trial is to study the effects of stellate ganglion block (SGB) in participants with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The main questions it aims to answer are:
Does SGB treatment improve symptoms of ME/CFS (e.g. brain fog, fatigue)? Do changes in symptoms go along with changes in blood or saliva?
Participants will receive a total of six blocks over three weeks (one block on each side, one day apart, per week). Prior to treatment and at two points following treatment, participants will complete surveys, take a cognitive (puzzle type) test, and provide blood and saliva for analysis. Participants will measure their heart rate daily using a free smart phone app.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age (18-50 years)
- •ME/CFS (CCC and IOM criteria) duration less than 4 years at time of study enrollment
- •Confirmed or suspected viral disease prior to ME/CFS onset (e.g., SARS-CoV-2, Epstein-Barr, Influenza)
- •BMI =18-29 kg/m^2
- •Ability to read, write and speak English language
排除标准
- •Prior SGB treatment
- •Allergy to amide local anesthetics (e.g. ropivacaine, bupivacaine)
- •Current anticoagulant use
- •History of bleeding disorder
- •History of glaucoma
- •Infection or mass at injection site
- •Anatomical abnormalities in C3-T1 region
- •Current pregnancy
- •Hypertension
- •Diabetes (any type)
- •Thyroid disease
- •History of neck or throat surgeries
- •Vocal cord problems or paralysis
- •Causalgia/Chronic Regional Pain Syndrome (CRPS)
- •Current cancer diagnosis
- •Diagnosis of Guillain-Barré syndrome
- •Diagnosis of current moderate or severe substance use disorder
- •History of neurological disease, seizure, or significant head trauma
- •Conditions or disorders (other than ME/CFS) that affect cognitive functioning including stroke, past or present diagnosis of psychosis or psychotic symptoms, diagnosis of bipolar I disorder, or severe depression
研究组 & 干预措施
Stellate Ganglion Block
The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Change in Subjective Rating of Symptoms at 2 Weeks
时间窗: 2 weeks
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two weeks for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).
Change in Subjective Rating of Symptoms at 2 Months
时间窗: 2 months
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two months for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).
Change in Cognitive Function at 2 Weeks
时间窗: 2 weeks
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces "brain fog" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two weeks post-treatment.
Change in Cognitive Function at 2 Months
时间窗: 2 months
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces "brain fog" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two months post-treatment.
次要结局
- Change in Orthostatic Tolerance at 2 Weeks(2 weeks)
- Change in Orthostatic Tolerance at 2 Months(2 months)
- Change in Autonomic Tone at 2 Weeks(2 weeks)
- Change in Autonomic Tone at 2 Months(2 months)