Clinical trial NCT06953661: Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Official title: Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome: A Randomized Double Blind Sham Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Keywords: stellate ganglion block
regional anesthesia
nerve block
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty patients will be enrolled, with 10 patients allocated to each study arm (treatment and control).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: COMPASS 31 total score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
Secondary outcomes:
measure: Magnitude of postural tachycardia
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: Heart rate variability (HRV)
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: Plasma catecholamine levels
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention)
measure: Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)
timeFrame: Baseline (within 1 week before study intervention) to 1-2 weeks, then 12 weeks following study intervention
measure: VOSS score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: FSS score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: PROMIS Cognitive Function Short Form 6a
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: EQ-5D score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: PGI-C rating
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: CGI-C rating
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: BAI score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: BDI score
timeFrame: Baseline (1 week before study intervention), first follow-up (1-2 weeks after the intervention) and second follow-up (12 weeks after the intervention)
measure: Adrenergic G-protein-coupled receptor autoantibody activity
timeFrame: Baseline (1 week before study intervention) and first follow-up (1-2 weeks after the intervention)
measure: Inflammatory markers (IL1, IL6, IL8, TNF)
timeFrame: Baseline (1 week before study intervention) and first follow-up (1-2 weeks after the intervention)
measure: Horner's syndrome
timeFrame: Within 10 minutes after the procedure
measure: Facial skin temperature
timeFrame: Within 10 minutes after the procedure
measure: Facial sweating
timeFrame: Within 10 minutes after the procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
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