Study Summary
This trial will investigate if SGB can improve symptoms in people with ME/CFS, and if so, what changes in the body accompany those improvements.
- Chronic Fatigue Syndrome (CFS)
- Chronic Fatigue Syndrome
- Myalgic Encephalomyelitis (ME)
- Chronic Infectious Mononucleosis-Like Syndrome
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 4 Secondary · Reporting Duration: 2 months
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Stellate Ganglion Block
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Stellate Ganglion Block · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · Female Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Liu, Luke D., and Deborah L. Duricka. 2022. “Stellate Ganglion Block Reduces Symptoms of Long COVID: A Case Series”. Journal of Neuroimmunology. Elsevier BV. doi:10.1016/j.jneuroim.2021.577784.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kang, Chang-Ki, Seung-Taek Oh, Rack Kyung Chung, Hyon Lee, Chan-A Park, Young-Bo Kim, Jeong Hyun Yoo, Dong Yeon Kim, and Zang-Hee Cho. 2010. “Effect of Stellate Ganglion Block on the Cerebrovascular System”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0b013e3181ec63f5.
- 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.
- 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.
- 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. 2022 May 16:17423953221101606. doi: 10.1177/17423953221101606. Online ahead of print.
- Nkiliza, Aurore, Megan Parks, Adam Cseresznye, Sarah Oberlin, James E. Evans, Teresa Darcey, Kristina Aenlle, et al.. 2021. “Sex-specific Plasma Lipid Profiles of ME/CFS Patients and Their Association with Pain, Fatigue, and Cognitive Symptoms”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-021-03035-6.
- 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.
- 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.
- 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.
- Mandarano, Alexandra H., Jessica Maya, Ludovic Giloteaux, Daniel L. Peterson, Marco Maynard, C. Gunnar Gottschalk, and Maureen R. Hanson. 2020. “Myalgic Encephalomyelitis/chronic Fatigue Syndrome Patients Exhibit Altered T Cell Metabolism and Cytokine Associations”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci132185.
- Pongratz G, Straub RH. The sympathetic nervous response in inflammation. Arthritis Res Ther. 2014;16(6):504. doi: 10.1186/s13075-014-0504-2.
- 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.
- 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.
- 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.
- 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.
- 2023. "Effect of Stellate Ganglion Block on ME/CFS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664711.
Frequently Asked Questions
Is this research protocol accepting participants aged 30 and up?
"This trial is open to adults between the ages of 18 and 50." - Anonymous Online Contributor
To what extent might Stellate Ganglion Block endanger patients?
"Taking into consideration the limited evidence available, Stellate Ganglion Block has been assessed by our team at Power to be of low risk and granted a score of 1." - Anonymous Online Contributor
Are new volunteers being accepted for this scientific experiment?
"Presently, this clinical trial is not actively seeking patients. The study was initiated on 1/1/2023 and last updated on 12/21/2022 according to the details posted on clinicaltrials.gov. Nonetheless, there are over 1800 other studies currently in search of volunteer participants." - Anonymous Online Contributor
What are the ultimate goals of this experiment?
"The primary aim of this two-week clinical trial is to analyse the Changes in Subjective Rating of Symptoms at 2 Months. Secondary objectives include gauging changes in Orthostatic Tolerance, Autonomic Tone, and Blood Oxidation both after a fortnight and once two months have passed since treatment began. To measure these metrics accurately, The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used for orthostatic tolerance while wearables such as rings worn on fingers paired with smartphones apps are employed for autonomic tone measurements over both time frames." - Anonymous Online Contributor
Might I be eligible to participate in this trial?
"A total of 10 individuals between the ages 18 and 50, who have been diagnosed with chronic fatigue syndrome by both CCC and IOM criteria in less than three years prior to enrollment are eligible for this trial. Additionally, those admitted must demonstrate evidence of a viral illness preceeding their ME/CFS diagnosis (e.g., SARS-CoV-2, Epstein-Barr or Influenza), possess a BMI ranging from 18 - 29 kg/m^2 and be able to comprehend English language proficiently." - Anonymous Online Contributor