Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome: A Randomized Double Blind Sham Placebo-controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- COMPASS 31 total score
研究概览
简要总结
This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.
详细描述
Postural Tachycardia Syndrome (POTS) is a heterogeneous condition affecting approximately 0.2% of the global population, predominantly young women of childbearing age. It is characterized by significant functional impairment and a constellation of symptoms, including lightheadedness, cognitive dysfunction, blurred vision, irritability, palpitations, and chest discomfort, which occur upon standing and improve when lying down. Although current pharmacological and non-pharmacological treatments alleviate symptoms for some patients, many remain significantly disabled. These challenges highlight the urgent need for novel treatment strategies, particularly non-pharmacological approaches.
This study is a randomized controlled trial with a control group. The study team will enroll 20 patients with POTS, assigning 10 to the intervention group and 10 to the control group.
The goal of the study is to evaluate the effectiveness of SGB in improving heart rate, markers of sympathetic hyperactivity, and POTS symptoms comparing to a sham saline injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult patients (>18 years of age) diagnosed with POTS
- •Ability to provide informed consent
- •Ability to comply with 3 follow up visits
- •English speaking and capable of signing informed consent and complying with protocol requirements
排除标准
- •Allergy to local anesthetics
- •Severe coagulopathy
- •History of or currently being treated for clinically significant ongoing cardiac arrhythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS
- •Inability to maintain a stable medication regiment for the duration of the study
研究组 & 干预措施
Intervention Group (stellate ganglion block)
Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine.
干预措施: Stellate ganglion block (Procedure)
Intervention Group (stellate ganglion block)
Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine.
干预措施: Ropivacaine (Drug)
Control Group (sham injection with saline)
Patients will receive a subcutaneous sham injection with saline. Ultrasound imaging will be used to simulate the guidance process as in the active procedure, maintaining consistency in the procedural experience.
干预措施: Sham injection of saline (Procedure)
Control Group (sham injection with saline)
Patients will receive a subcutaneous sham injection with saline. Ultrasound imaging will be used to simulate the guidance process as in the active procedure, maintaining consistency in the procedural experience.
干预措施: Normal saline (Drug)
结局指标
主要结局
COMPASS 31 total score
时间窗: Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)
The change in Composite Autonomic Symptom Score 31 (COMPASS-31) from baseline to first follow-up visit. The COMPASS-31 scale measures autonomic dysfunctions through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction.
次要结局
- Facial skin temperature(Within 10 minutes after the procedure)
- Facial sweating(Within 10 minutes after the procedure)
- Magnitude of postural tachycardia(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Heart rate variability (HRV)(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Plasma catecholamine levels(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)(Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention)
- VOSS score(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- FSS score(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- PROMIS Cognitive Function Short Form 6a(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- EQ-5D score(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- PGI-S rating(Baseline (day -21 to -1 before intervention))
- PGI-C rating(First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- CGI-S rating(Baseline (day -21 to -1 before intervention))
- CGI-C rating(First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- BAI score(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- BDI score(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Adrenergic G-protein-coupled receptor autoantibody activity(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Inflammatory markers (including but not limited to IL1, IL6, IL8, TNF)(Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention))
- Horner's syndrome(Within 10 minutes after the procedure)
研究者
Anna Maria Bombardieri
Clinical Associate Professor
Stanford University