Effect of Stellate Ganglion Block on ME/CFS (SGB_ME)

March 19, 2024 updated by: Neuroversion, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Neuroversion
        • Contact:
        • Principal Investigator:
          • Deborah L Duricka, PhD
        • Sub-Investigator:
          • Luke D Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate Ganglion Block
The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.
Drug: Bupivacaine Injection

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.

Other Names:
  • stellate ganglion block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Rating of Symptoms at 2 Weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Salivary Cortisol upon Awakening at 2 Weeks
Time Frame: 2 weeks
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.
2 weeks
Change in Salivary Cortisol Upon Awakening at 2 Months
Time Frame: 2 months
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.
2 months
Change in Metabolites at 2 Weeks
Time Frame: 2 weeks
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.
2 weeks
Change in Metabolites at 2 Months
Time Frame: 2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroversion, Inc.

Investigators

  • Principal Investigator: Deborah L Duricka, PhD, Neuroversion, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

December 21, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20193104

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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