Effect of Stellate Ganglion Block on ME/CFS

NCT05664711 | Completed Phase 1 FDA Drug

• 1 other identifier: 20193104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in Orthostatic Tolerance at 2 Weeks

  2 weeks

• Change in Orthostatic Tolerance at 2 Months

  2 months

• Change in Autonomic Tone at 2 Weeks

  2 weeks

• Change in Autonomic Tone at 2 Months

  2 months

Other Outcomes (4)

• Change in Salivary Cortisol upon Awakening at 2 Weeks

  2 weeks

• Change in Salivary Cortisol Upon Awakening at 2 Months

  2 months

• Change in Metabolites at 2 Weeks

  2 weeks

Study Arms (1)

Stellate Ganglion Block

EXPERIMENTAL

The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.

Drug: Bupivacaine Injection

Interventions

Bupivacaine Injection DRUG

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.

Also known as: stellate ganglion block

Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuroversion, Inc.: lead

Study Sites (1)

Neuroversion

Anchorage, Alaska, 99508, United States

Location

Related Publications (20)

• Liu LD, Duricka DL. Stellate ganglion block reduces symptoms of Long COVID: A case series. J Neuroimmunol. 2022 Jan 15;362:577784. doi: 10.1016/j.jneuroim.2021.577784. Epub 2021 Dec 8.

  PMID: 34922127 BACKGROUND

• van Campen CLMC, Rowe PC, Visser FC. Cerebral blood flow remains reduced after tilt testing in myalgic encephalomyelitis/chronic fatigue syndrome patients. Clin Neurophysiol Pract. 2021 Sep 23;6:245-255. doi: 10.1016/j.cnp.2021.09.001. eCollection 2021.

  PMID: 34667909 BACKGROUND

• Campen CLMCV, Rowe PC, Visser FC. Orthostatic Symptoms and Reductions in Cerebral Blood Flow in Long-Haul COVID-19 Patients: Similarities with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Medicina (Kaunas). 2021 Dec 24;58(1):28. doi: 10.3390/medicina58010028.

  PMID: 35056336 BACKGROUND

• Tokumasu K, Honda H, Sunada N, Sakurada Y, Matsuda Y, Yamamoto K, Nakano Y, Hasegawa T, Yamamoto Y, Otsuka Y, Hagiya H, Kataoka H, Ueda K, Otsuka F. Clinical Characteristics of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Diagnosed in Patients with Long COVID. Medicina (Kaunas). 2022 Jun 25;58(7):850. doi: 10.3390/medicina58070850.

  PMID: 35888568 BACKGROUND

• Umeyama T, Kugimiya T, Ogawa T, Kandori Y, Ishizuka A, Hanaoka K. Changes in cerebral blood flow estimated after stellate ganglion block by single photon emission computed tomography. J Auton Nerv Syst. 1995 Jan 3;50(3):339-46. doi: 10.1016/0165-1838(94)00105-s.

  PMID: 7714328 BACKGROUND

• Park HM, Kim TW, Choi HG, Yoon KB, Yoon DM. The change in regional cerebral oxygen saturation after stellate ganglion block. Korean J Pain. 2010 Jun;23(2):142-6. doi: 10.3344/kjp.2010.23.2.142. Epub 2010 May 31.

  PMID: 20556217 BACKGROUND

• Kang CK, Oh ST, Chung RK, Lee H, Park CA, Kim YB, Yoo JH, Kim DY, Cho ZH. Effect of stellate ganglion block on the cerebrovascular system: magnetic resonance angiography study. Anesthesiology. 2010 Oct;113(4):936-44. doi: 10.1097/ALN.0b013e3181ec63f5.

  PMID: 20823762 BACKGROUND

• Medow MS, Sood S, Messer Z, Dzogbeta S, Terilli C, Stewart JM. Phenylephrine alteration of cerebral blood flow during orthostasis: effect on n-back performance in chronic fatigue syndrome. J Appl Physiol (1985). 2014 Nov 15;117(10):1157-64. doi: 10.1152/japplphysiol.00527.2014. Epub 2014 Oct 2.

  PMID: 25277740 BACKGROUND

• Staud R, Boissoneault J, Craggs JG, Lai S, Robinson ME. Task Related Cerebral Blood Flow Changes of Patients with Chronic Fatigue Syndrome: An Arterial Spin Labeling Study. Fatigue. 2018;6(2):63-79. doi: 10.1080/21641846.2018.1453919. Epub 2018 Mar 20.

  PMID: 29707427 BACKGROUND

• Jason LA, Gaglio CL, Furst J, Islam M, Sorenson M, Conroy KE, Katz BZ. Cytokine network analysis in a community-based pediatric sample of patients with myalgic encephalomyelitis/chronic fatigue syndrome. Chronic Illn. 2023 Sep;19(3):571-580. doi: 10.1177/17423953221101606. Epub 2022 May 16.

  PMID: 35570777 BACKGROUND

• Nkiliza A, Parks M, Cseresznye A, Oberlin S, Evans JE, Darcey T, Aenlle K, Niedospial D, Mullan M, Crawford F, Klimas N, Abdullah L. Sex-specific plasma lipid profiles of ME/CFS patients and their association with pain, fatigue, and cognitive symptoms. J Transl Med. 2021 Aug 28;19(1):370. doi: 10.1186/s12967-021-03035-6.

  PMID: 34454515 BACKGROUND

• Giloteaux L, O'Neal A, Castro-Marrero J, Levine SM, Hanson MR. Cytokine profiling of extracellular vesicles isolated from plasma in myalgic encephalomyelitis/chronic fatigue syndrome: a pilot study. J Transl Med. 2020 Oct 12;18(1):387. doi: 10.1186/s12967-020-02560-0.

  PMID: 33046133 BACKGROUND

• Wirth K, Scheibenbogen C. A Unifying Hypothesis of the Pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Recognitions from the finding of autoantibodies against ss2-adrenergic receptors. Autoimmun Rev. 2020 Jun;19(6):102527. doi: 10.1016/j.autrev.2020.102527. Epub 2020 Apr 1.

  PMID: 32247028 BACKGROUND

• Che X, Brydges CR, Yu Y, Price A, Joshi S, Roy A, Lee B, Barupal DK, Cheng A, Palmer DM, Levine S, Peterson DL, Vernon SD, Bateman L, Hornig M, Montoya JG, Komaroff AL, Fiehn O, Lipkin WI. Metabolomic Evidence for Peroxisomal Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Int J Mol Sci. 2022 Jul 18;23(14):7906. doi: 10.3390/ijms23147906.

  PMID: 35887252 BACKGROUND

• Mandarano AH, Maya J, Giloteaux L, Peterson DL, Maynard M, Gottschalk CG, Hanson MR. Myalgic encephalomyelitis/chronic fatigue syndrome patients exhibit altered T cell metabolism and cytokine associations. J Clin Invest. 2020 Mar 2;130(3):1491-1505. doi: 10.1172/JCI132185.

  PMID: 31830003 BACKGROUND

• Pongratz G, Straub RH. The sympathetic nervous response in inflammation. Arthritis Res Ther. 2014;16(6):504. doi: 10.1186/s13075-014-0504-2.

  PMID: 25789375 BACKGROUND

• Jonsjo MA, Olsson GL, Wicksell RK, Alving K, Holmstrom L, Andreasson A. The role of low-grade inflammation in ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) - associations with symptoms. Psychoneuroendocrinology. 2020 Mar;113:104578. doi: 10.1016/j.psyneuen.2019.104578. Epub 2019 Dec 26.

  PMID: 31901625 BACKGROUND

• Sharma D, Farrar JD. Adrenergic regulation of immune cell function and inflammation. Semin Immunopathol. 2020 Dec;42(6):709-717. doi: 10.1007/s00281-020-00829-6. Epub 2020 Nov 20.

  PMID: 33219396 BACKGROUND

• Sugimoto M, Shimaoka M, Taenaka N, Kiyono H, Yoshiya I. Lymphocyte activation is attenuated by stellate ganglion block. Reg Anesth Pain Med. 1999 Jan-Feb;24(1):30-5. doi: 10.1016/s1098-7339(99)90162-1.

  PMID: 9952092 BACKGROUND

• Yokoyama M, Nakatsuka H, Itano Y, Hirakawa M. Stellate ganglion block modifies the distribution of lymphocyte subsets and natural-killer cell activity. Anesthesiology. 2000 Jan;92(1):109-15. doi: 10.1097/00000542-200001000-00021.

  PMID: 10638906 BACKGROUND

Related Links

• Solve M.E. Ramsay Grant 2022-2023-- Meet the Researchers
• Centers for Disease Control and Prevention (CDC). Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Last Reviewed: November 25, 2022
• ME/CFS clinical trials

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Mental Fatigue; Orthostatic Intolerance

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior; Primary Dysautonomias; Autonomic Nervous System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Deborah L Duricka, PhD

  Neuroversion, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 27, 2022
• Study Start: March 15, 2023
• Primary Completion: December 21, 2023
• Study Completion: January 15, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)