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Postural Tachycardia SyndromeNCT06953661

Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

A study testing Stellate ganglion block, Ropivacaine and Normal saline in people with Postural Tachycardia Syndrome, run by Stanford University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postural Tachycardia Syndrome
What is being tested?
Stellate ganglion block, Ropivacaine and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesUnited States
Study dates
16 Oct 2025to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Maria Bombardieri, MD, PhD contact

3143269107

abomba@stanford.edu

Ksenia Kasimova, MD contact

6507889458

kasimova@stanford.edu

United States2 sites, 2 recruiting
  • Stanford University School of Medicine

    Stanford, California, 94304

    Anna Maria Bombardieri, MD, PhD, 314-326-9107, abomba@stanford.edu

    Recruiting
  • Stanford University

    Stanford, California, 94305

    Anna Maria Bombardieri, MD, abomba@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome: A Randomized Double Blind Sham Placebo-controlled Pilot Study

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.

Read the 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.

Being tested
Stellate ganglion block, Sham injection of saline, Ropivacaine, Normal saline
Keywords
stellate ganglion block, regional anesthesia, nerve block
Medical subject headings
Postural Orthostatic Tachycardia Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stellate ganglion blockProcedure or surgery

    Patients will receive a SGB

  • Sham injection of salineProcedure or surgery

    Patients will receive a subcutaneous sham injection of saline

  • RopivacaineDrug

    The SGB group will receive ropivacaine 0.5% 10ml

  • Normal salineDrug

    The control group will receive normal saline in the sham injection.

Study groups in NCT06953661
Study groupRoleWhat they receive
Intervention Group (stellate ganglion block)ExperimentalPatients will receive an ultrasound guided stellate ganglion block (SGB) with 10 ml of 0.5% ropivacaine.
Receives: Procedure: Stellate ganglion block; Drug: Ropivacaine
Control Group (sham injection with saline)Sham comparatorPatients 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.
Receives: Procedure: Sham injection of saline; Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

Secondary outcomes (19)
  1. 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.

    Measured: 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)

  2. Heart rate variability (HRV)

    Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit

    Measured: 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)

  3. Plasma catecholamine levels

    Measure the change in plasma catecholamine levels from baseline to first and second follow up visits

    Measured: 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)

  4. 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.

    Measured: Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: Baseline (day -21 to -1 before intervention)

  10. 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.

    Measured: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

  11. 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.

    Measured: Baseline (day -21 to -1 before intervention)

  12. 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).

    Measured: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)

  13. 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.

    Measured: 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)

  14. 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.

    Measured: 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)

  15. 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.

    Measured: 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)

  16. 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

    Measured: 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)

  17. Horner's syndrome

    Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success

    Measured: Within 10 minutes after the procedure

  18. Facial skin temperature

    Measure the change in facial skin temperature (C°) post-procedure

    Measured: Within 10 minutes after the procedure

  19. 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.

    Measured: Within 10 minutes after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start16 Oct 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Twenty patients will be enrolled, with 10 patients allocated to each study arm (treatment and control).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06953661
Sponsor's protocol ID
80519
Status last verified
Oct 2026
First submitted
22 Apr 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vernino S, Bourne KM, Stiles LE, Grubb BP, Fedorowski A, Stewart JM, Arnold AC, Pace LA, Axelsson J, Boris JR, Moak JP, Goodman BP, Chemali KR, Chung TH, Goldstein DS, Diedrich A, Miglis MG, Cortez MM, Miller AJ, Freeman R, Biaggioni I, Rowe PC, Sheldon RS, Shibao CA, Systrom DM, Cook GA, Doherty TA, Abdallah HI, Darbari A, Raj SR. Postural orthostatic tachycardia syndrome (POTS): State of the science and clinical care from a 2019 National Institutes of Health Expert Consensus Meeting - Part 1. Auton Neurosci. 2021 Nov;235:102828. doi: 10.1016/j.autneu.2021.102828. Epub 2021 Jun 5.

    PubMed 34144933
  • Doherty TA, White AA. Postural orthostatic tachycardia syndrome and the potential role of mast cell activation. Auton Neurosci. 2018 Dec;215:83-88. doi: 10.1016/j.autneu.2018.05.001. Epub 2018 May 4.

    PubMed 30033040
  • Duricka D, Liu L. Reduction of long COVID symptoms after stellate ganglion block: A retrospective chart review study. Auton Neurosci. 2024 Aug;254:103195. doi: 10.1016/j.autneu.2024.103195. Epub 2024 Jun 13.

    PubMed 38901177
  • Pearson L, Maina A, Compratt T, Harden S, Aaroe A, Copas W, Thompson L. Stellate Ganglion Block Relieves Long COVID-19 Symptoms in 86% of Patients: A Retrospective Cohort Study. Cureus. 2023 Sep 13;15(9):e45161. doi: 10.7759/cureus.45161. eCollection 2023 Sep.

    PubMed 37711269
  • Cha YM, Li X, Yang M, Han J, Wu G, Kapa SC, McLeod CJ, Noseworthy PA, Mulpuru SK, Asirvatham SJ, Brady PA, Rho RH, Friedman PA, Lee HC, Tian Y, Zhou S, Munger TM, Ackerman MJ, Shen WK. Stellate ganglion block and cardiac sympathetic denervation in patients with inappropriate sinus tachycardia. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2920-2928. doi: 10.1111/jce.14233. Epub 2019 Nov 6.

    PubMed 31625219
  • Larsen NW, Stiles LE, Miglis MG. Preparing for the long-haul: Autonomic complications of COVID-19. Auton Neurosci. 2021 Nov;235:102841. doi: 10.1016/j.autneu.2021.102841. Epub 2021 Jul 3.

    PubMed 34265539

Questions about this trial

What is this clinical trial studying?

A study testing Stellate ganglion block, Ropivacaine and Normal saline in people with Postural Tachycardia Syndrome, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Maria Bombardieri, MD, PhD (3143269107, abomba@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COMPASS 31 total score (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06953661, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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