Back to resultsEffect of Stellate Ganglion Block on ME/CFS (SGB_ME)
Primary Purpose
Encephalomyelitis, Myalgic, Chronic Fatigue Syndrome, Chronic Fatigue Disorder
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Encephalomyelitis, Myalgic focused on measuring ME/CFS, myalgic encephalomyelitis, chronic fatigue syndrome, stellate ganglion block, SGB, cervical sympathetic block, post-exertional malaise, PEM, exertional intolerance, brain fog, orthostatic intolerance
Eligibility Criteria
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
Sites / Locations
- Neuroversion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stellate Ganglion Block
Arm Description
The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05664711
Brief Title
Effect of Stellate Ganglion Block on ME/CFS
Acronym
SGB_ME
Official Title
Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuroversion, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
ME/CFS, myalgic encephalomyelitis, chronic fatigue syndrome, stellate ganglion block, SGB, cervical sympathetic block, post-exertional malaise, PEM, exertional intolerance, brain fog, orthostatic intolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion Block
Arm Type
Experimental
Arm Description
The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
stellate ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Subjective Rating of Symptoms at 2 Weeks
Description
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).
Time Frame
2 weeks
Title
Change in Subjective Rating of Symptoms at 2 Months
Description
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).
Time Frame
2 months
Title
Change in Cognitive Function at 2 Weeks
Description
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.
Time Frame
2 weeks
Title
Change in Cognitive Function at 2 Months
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in Orthostatic Tolerance at 2 Weeks
Description
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.
Time Frame
2 weeks
Title
Change in Orthostatic Tolerance at 2 Months
Description
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.
Time Frame
2 months
Title
Change in Autonomic Tone at 2 Weeks
Description
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.
Time Frame
2 weeks
Title
Change in Autonomic Tone at 2 Months
Description
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.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Change in Salivary Cortisol upon Awakening at 2 Weeks
Description
Concentration of free cortisol in saliva upon awakening will be measured in micrograms per deciliter (ug/dL) using Enzyme-Linked Immunosorbent Assay (ELISA), at baseline and two weeks after treatment. ME/CFS patients have abnormally low levels of cortisol in general and upon awakening. An increased concentration within the normal range (from 0.007 ug/dL to 0.115 ug/dL) indicates a better outcome.
Time Frame
2 weeks
Title
Change in Salivary Cortisol Upon Awakening at 2 Months
Description
Concentration of free cortisol in saliva upon awakening will be measured in micrograms per deciliter (ug/dL) using Enzyme-Linked Immunosorbent Assay (ELISA), at baseline and two months after treatment. ME/CFS patients have abnormally low levels of cortisol in general and upon awakening. An increased concentration within the normal range (from 0.007 ug/dL to 0.115 ug/dL) indicates a better outcome.
Time Frame
2 months
Title
Change in Metabolites at 2 Weeks
Description
Plasma will be analyzed by liquid chromatography/mass spectrometry (LC/MS) to determine the levels of 433 hydrophilic metabolites (relative to an unchanging molecule in plasma) at baseline and at two weeks after treatment. ME/CFS patients are known to have abnormally high or low amounts of many metabolites, indicating mitochondrial dysfunction. Changes in abnormal metabolites toward normal values would indicate a better outcome.
Time Frame
2 weeks
Title
Change in Metabolites at 2 Months
Description
Plasma will be analyzed by liquid chromatography/mass spectrometry (LC/MS) to determine the levels of 433 hydrophilic metabolites (relative to an unchanging molecule in plasma) at baseline and at two months after treatment. ME/CFS patients are known to have abnormally high or low amounts of many metabolites, indicating mitochondrial dysfunction. Changes in abnormal metabolites toward normal values would indicate a better outcome.
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L Duricka, PhD
Organizational Affiliation
Neuroversion, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuroversion
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
12. IPD Sharing Statement
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Links:
URL
https://solvecfs.org/research/ramsay-research-grants/meet-the-researchers/
Description
Solve M.E. Ramsay Grant 2022-2023-- Meet the Researchers
URL
https://www.cdc.gov/me-cfs/index.html
Description
Centers for Disease Control and Prevention (CDC). Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Last Reviewed: November 25, 2022
URL
https://clinicaltrials.gov/ct2/results?term=chronic+fatigue+syndrome+myalgic+encephalomyelitis&Search=Search
Description
ME/CFS clinical trials
Learn more about this trial
Effect of Stellate Ganglion Block on ME/CFS
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