Effect of Stellate Ganglion Block on ME/CFS

Study Overview
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Brief Summary
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The goal of this clinical trial is to study the effects of stellate ganglion block (SGB) in participants with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The main questions it aims to answer are: Does SGB treatment improve symptoms of ME/CFS (e.g. brain fog, fatigue)? Do changes in symptoms go along with changes in blood or saliva? Participants will receive a total of six blocks over three weeks (one block on each side, one day apart, per week). Prior to treatment and at two points following treatment, participants will complete surveys, take a cognitive (puzzle type) test, and provide blood and saliva for analysis. Participants will measure their heart rate daily using a free smart phone app.

Official Title
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Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites

Conditions
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Encephalomyelitis, Myalgic, Chronic Fatigue Syndrome, Chronic Fatigue Disorder, Chronic Fatigue and Immune Dysfunction Syndrome, Myalgic Encephalomyelitis, Postviral Fatigue Syndrome, Systemic Exertion Intolerance Disease, Infectious Mononucleosis-Like Syndrome, Chronic, Chronic Fatigue-Fibromyalgia Syndrome

Intervention / Treatment
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* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (18-50 years) Female ME/CFS (CCC and IOM criteria) duration less than 4 years at time of study enrollment Confirmed or suspected viral disease prior to ME/CFS onset (e.g., SARS-CoV-2, Epstein-Barr, Influenza) BMI =18-29 kg/m^2 Ability to read, write and speak English language Exclusion Criteria: Prior SGB treatment Allergy to amide local anesthetics (e.g. ropivacaine, bupivacaine) Current anticoagulant use History of bleeding disorder History of glaucoma Infection or mass at injection site Anatomical abnormalities in C3-T1 region Current pregnancy Hypertension Diabetes (any type) Thyroid disease History of neck or throat surgeries Vocal cord problems or paralysis Causalgia/Chronic Regional Pain Syndrome (CRPS) Current cancer diagnosis Diagnosis of Guillain-Barré syndrome Diagnosis of current moderate or severe substance use disorder History of neurological disease, seizure, or significant head trauma Conditions or disorders (other than ME/CFS) that affect cognitive functioning including stroke, past or present diagnosis of psychosis or psychotic symptoms, diagnosis of bipolar I disorder, or severe depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate Ganglion Block<br>The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance. | Drug: Bupivacaine Injection<br>* Reciprocal unilateral stellate ganglion blocks, separated by at least 16 hours, will be given once per week for three weeks (for a total of 6 blocks). This study is not intended to be reported to FDA as a well-controlled study in support of a new indication for bupivacaine or to support any other significant change in the labeling for the drug.<br>* Other names: stellate ganglion block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Rating of Symptoms at 2 Weeks | The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two weeks for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation). | 2 weeks | 
| Change in Subjective Rating of Symptoms at 2 Months | The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two months for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation). | 2 months | 
| Change in Cognitive Function at 2 Weeks | The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces brain fog as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two weeks post-treatment. | 2 weeks | 
| Change in Cognitive Function at 2 Months | The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces brain fog as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two months post-treatment. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Orthostatic Tolerance at 2 Weeks | The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 weeks post-treatment. | 2 weeks | 
| Change in Orthostatic Tolerance at 2 Months | The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 months post-treatment. | 2 months | 
| Change in Autonomic Tone at 2 Weeks | A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two weeks after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka autonomic tone). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation. | 2 weeks | 
| Change in Autonomic Tone at 2 Months | A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two months after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka autonomic tone). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation compared to baseline. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ME/CFS, myalgic encephalomyelitis, chronic fatigue syndrome, stellate ganglion block, SGB, cervical sympathetic block, post-exertional malaise, PEM, exertional intolerance, brain fog, orthostatic intolerance