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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Patients will receive a SGB
Patients will receive a subcutaneous sham injection of saline
The SGB group will receive ropivacaine 0.5% 10ml
Stanford University School of Medicine
Stanford, California, United States
Stanford University
Stanford, California, United States
COMPASS 31 total score
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.
Time frame: 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)
Magnitude of postural tachycardia
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.
Time frame: 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)
Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit
Time frame: 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
Measure the change in plasma catecholamine levels from baseline to first and second follow up visits
Time frame: 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)
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.
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The control group will receive normal saline in the sham injection.
Time frame: Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention
VOSS score
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
The PGI-S (Patient Global Impression of Severity) is a single-item, 7-point scale used to assess a patient's perception of the current severity of their condition. A rating of 1 indicates "normal, not at all ill," while a rating of 7 indicates "among the most extremely ill patients." This self-reported measure provides a global assessment of illness severity from the patient's perspective and is commonly used in clinical trials to gauge baseline condition or monitor progression over time.
Time frame: Baseline (day -21 to -1 before intervention)
PGI-C rating
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.
Time frame: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)
CGI-S rating
The CGI-S (Clinical Global Impression of Severity) is a 7-point scale used by clinicians to assess the severity of a patient's illness at a given point in time. A rating of 1 indicates "normal, not at all ill," while a rating of 7 indicates "among the most extremely ill patients." This clinician-rated measure provides an overall impression of the patient's current condition, based on clinical judgment and all available information, including patient history, symptoms, and behavior.
Time frame: Baseline (day -21 to -1 before intervention)
CGI-C rating
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).
Time frame: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)
BAI score
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.
Time frame: 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
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.
Time frame: 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
Measure the change in adrenergic G-protein-coupled receptor autoantibody concentrations from baseline to first and second follow up visits from stored serum samples.
Time frame: 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)
Measure the change in inflammatory markers concentrations (including but not limited to IL1, IL6, IL8, TNF) from baseline to first and second follow up visits from stored serum samples
Time frame: 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
Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success
Time frame: Within 10 minutes after the procedure
Facial skin temperature
Measure the change in facial skin temperature (C°) post-procedure
Time frame: Within 10 minutes after the procedure
Facial sweating
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.
Time frame: Within 10 minutes after the procedure