Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
- Conditions
- Postural Tachycardia Syndrome
- Interventions
- Procedure: Stellate ganglion blockProcedure: Sham injection of salineDrug: Normal saline
- Registration Number
- NCT06953661
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (stellate ganglion block) Stellate ganglion block Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine. Intervention Group (stellate ganglion block) Ropivacaine Patients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine. Control Group (sham injection with saline) Sham injection of 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. Control Group (sham injection with saline) Normal 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.
- Primary Outcome Measures
Name Time Method COMPASS 31 total score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks 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.
- Secondary Outcome Measures
Name Time Method Horner's syndrome Within 10 minutes after the procedure Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success
Facial skin temperature Within 10 minutes after the procedure Measure the change in facial skin temperature (C°) post-procedure
Plasma catecholamine levels Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) Measure the change in plasma catecholamine levels from baseline to first follow up visit
Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS) Baseline (within 1 week before study intervention) to 1-2 weeks, then 12 weeks following study intervention SPOTS evaluates the frequency and severity of common POTS symptoms, The higher the score, the greater the symptom burden. A reduction in SPOTS score suggests clinical improvement. SPOTS scores at 1st and 2nd FU are compared to baseline SPOTS scores.
VOSS score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in VOSS score at 1st and 2nd FU compared to baseline. The Vanderbilt Orthostatic Symptom Score (VOSS) is a tool used to assess and track the severity of symptoms associated with postural orthostatic tachycardia syndrome (POTS). It helps quantify a patient's symptom burden by having them rate the severity of 9 symptoms (mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea) on a scale of 0 to 10, where 0 indicates no symptoms.
CGI-C rating Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) The Clinical Global Impression of Change (CGI-C) is a scale used to assess the clinical change or improvement in a patient's condition over time. CGI-C scores range from 1 (very much improved) through to 7 (very much worse).
BAI score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Reduction in anxiety and depression symptoms as measured by the BAI score. Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Each item is rated on a 4-point scale (0 = not at all to 3 = severely). The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms.
BDI score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Reduction in anxiety and depression symptoms as measured by the BDI score. Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. The total score ranges from 0 to 63. Higher total scores indicate more severe depressive symptoms.
Adrenergic G-protein-coupled receptor autoantibody activity Baseline (1 week before study intervention) and first follow-up (1-2 weeks after the intervention) Measure the change in adrenergic G-protein-coupled receptor autoantibody concentrations from baseline to first follow up visit from stored serum samples.
Inflammatory markers (IL1, IL6, IL8, TNF) Baseline (1 week before study intervention) and first follow-up (1-2 weeks after the intervention) Measure the change in inflammatory markers concentrations (IL1, IL6, IL8, TNF) from baseline to first follow up visit from stored serum samples
Facial sweating Within 10 minutes after the procedure Sweat testing will be performed following the procedure. The patient is coated with a moisture-sensitive powder that changes color following the increase in facial blood flow following the intervention.
FSS score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in FSS score at 1st and 2nd FU compared to baseline. The Fatigue Severity Scale (FSS) is a questionnaire used to measure the severity of fatigue and its impact on daily activities. It's a 9-item scale where respondents rate their agreement with statements about fatigue using a 7-point scale, with 1 being "strongly disagree" and 7 being "strongly agree". The total FSS score is calculated by summing the responses, with a higher score indicating greater fatigue severity.
PROMIS Cognitive Function Short Form 6a Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in the PROMIS Cognitive Function Short Form 6a score at 1st and 2nd FU compared to baseline. Short Form 6a is a six-item sub-set scale of the PROMIS (Patient Reported Outcomes Measurement Information System) Cognitive Function item bank that assesses patient-perceived cognitive deficits. The questions use a 5-point response scale, ranging from "Not at all" to "Very much". A higher score generally indicates better perceived cognitive ability.
EQ-5D score Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in EQ-5D score at 1st and 2nd FU compared to baseline. The EQ-5D is a questionnaire for measuring patient-reported outcomes which assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 to 1, where 1 represents perfect health, 0 represents a state as bad as death, and values between 0 and 1 represent different levels of health, with higher values indicating better health.
PGI-C rating Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) The PGI-C (Patient Global Impression of Change) is a 7-point scale used to assess a patient's perceived change in their health or condition after an intervention. A rating of 1 indicates "very much improved," while a rating of 7 indicates "very much worse". It's a self-reported measure that reflects a patient's belief about the efficacy of treatment.
Magnitude of postural tachycardia Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in magnitude of postural tachycardia (a heart rate increase within the first 10 minutes of standing) from baseline to first and second follow up visit.
Heart rate variability (HRV) Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention) Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit
Trial Locations
- Locations (2)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Stanford University
🇺🇸Stanford, California, United States