Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Stellate ganglion block
  Patients will receive a SGB
• Процедура Sham injection of saline
  Patients will receive a subcutaneous sham injection of saline
• Препарат Ropivacaine
  The SGB group will receive ropivacaine 0.5% 10ml
• Препарат Normal saline
  The control group will receive normal saline in the sham injection.

Первичные конечные точки

• COMPASS 31 total score [Срок оценки: 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)]

Вторичные конечные точки (12)

• Magnitude of postural tachycardia [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention]
• VOSS score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (day -21 to -1 before intervention)]
• PGI-C rating [Срок оценки: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)]
• CGI-S rating [Срок оценки: Baseline (day -21 to -1 before intervention)]
• CGI-C rating [Срок оценки: First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Stanford University School of Medicine — Stanford
• Stanford University — Stanford

Публикации

• 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 sci PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34265539

Идентификаторы

NCT: NCT06953661 · 80519

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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