Effect of Stellate Ganglion Block on ME/CFS

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.

Timeline

Start

2023-03-15

Primary completion

2023-12-21

Completion

2024-01-15

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications