Study Summary
This trial will assess if a nerve block can help reduce symptoms of long COVID.
- Dysautonomia
- Dysautonomia Orthostatic Hypotension Syndrome
- Post-COVID Syndrome
- Long COVID
- COVID-19 Recurrence
- COVID-19
- Post-Acute COVID-19 Syndrome
- Post-Acute COVID-19 Infection
- Long COVID Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
8 Primary · 1 Secondary · Reporting Duration: 1 month
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Active
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Active · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 100 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Ganesh R, Ghosh AK, Nyman MA, Croghan IT, Grach SL, Anstine CV, Salonen BR, Hurt RT. PROMIS Scales for Assessment of Persistent Post-COVID Symptoms: A Cross Sectional Study. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211030413. doi: 10.1177/21501327211030413.
- Kenney MJ, Ganta CK. Autonomic nervous system and immune system interactions. Compr Physiol. 2014 Jul;4(3):1177-200. doi: 10.1002/cphy.c130051.
- 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.
- Carod-Artal FJ. Infectious diseases causing autonomic dysfunction. Clin Auton Res. 2018 Feb;28(1):67-81. doi: 10.1007/s10286-017-0452-4. Epub 2017 Jul 20.
- Qin Y, Wu J, Chen T, Li J, Zhang G, Wu D, Zhou Y, Zheng N, Cai A, Ning Q, Manyande A, Xu F, Wang J, Zhu W. Long-term microstructure and cerebral blood flow changes in patients recovered from COVID-19 without neurological manifestations. J Clin Invest. 2021 Apr 15;131(8):e147329. doi: 10.1172/JCI147329.
- Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20. Erratum In: Diabetes Metab Syndr. 2022 May;16(5):102504. Diabetes Metab Syndr. 2022 Nov 7;:102660.
- Tian T, Wu J, Chen T, Li J, Yan S, Zhou Y, Peng X, Li Y, Zheng N, Cai A, Ning Q, Xiang H, Xu F, Qin Y, Zhu W, Wang J. Long-term follow-up of dynamic brain changes in patients recovered from COVID-19 without neurological manifestations. JCI Insight. 2022 Feb 22;7(4):e155827. doi: 10.1172/jci.insight.155827.
- Wadehra S. COVID Long Haulers and the New Chronic Pain Profile . Pract Pain Manag. 2022;22(1).
- Wulf H, Maier C. [Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. Anaesthesist. 1992 Mar;41(3):146-51. German.
- Attal N, Martinez V, Bouhassira D. Potential for increased prevalence of neuropathic pain after the COVID-19 pandemic. Pain Rep. 2021 Jan 27;6(1):e884. doi: 10.1097/PR9.0000000000000884. eCollection 2021 Jan-Feb.
- Datta R, Agrawal J, Sharma A, Rathore VS, Datta S. A study of the efficacy of stellate ganglion blocks in complex regional pain syndromes of the upper body. J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):534-540. doi: 10.4103/joacp.JOACP_326_16.
- Grebe KM, Takeda K, Hickman HD, Bailey AL, Embry AC, Bennink JR, Yewdell JW. Cutting edge: Sympathetic nervous system increases proinflammatory cytokines and exacerbates influenza A virus pathogenesis. J Immunol. 2010 Jan 15;184(2):540-4. doi: 10.4049/jimmunol.0903395. Epub 2009 Dec 16. Erratum In: J Immunol. 2010 Mar 1;184(5):2736. Bailey, Adam M [corrected to Bailey, Adam L].
- Lipov EG, Navaie M, Brown PR, Hickey AH, Stedje-Larsen ET, McLay RN. Stellate ganglion block improves refractory post-traumatic stress disorder and associated memory dysfunction: a case report and systematic literature review. Mil Med. 2013 Feb;178(2):e260-4. doi: 10.7205/MILMED-D-12-00290.
- Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. Erratum In: JAMA Psychiatry. 2020 Jan 2;: JAMA Psychiatry. 2020 Sep 1;77(9):982.
- Tian Y, Wittwer ED, Kapa S, McLeod CJ, Xiao P, Noseworthy PA, Mulpuru SK, Deshmukh AJ, Lee HC, Ackerman MJ, Asirvatham SJ, Munger TM, Liu XP, Friedman PA, Cha YM. Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007118. doi: 10.1161/CIRCEP.118.007118. Epub 2019 Sep 13.
- Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
- 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.
- Carmona-Torre F, Minguez-Olaondo A, Lopez-Bravo A, Tijero B, Grozeva V, Walcker M, Azkune-Galparsoro H, Lopez de Munain A, Alcaide AB, Quiroga J, Del Pozo JL, Gomez-Esteban JC. Dysautonomia in COVID-19 Patients: A Narrative Review on Clinical Course, Diagnostic and Therapeutic Strategies. Front Neurol. 2022 May 27;13:886609. doi: 10.3389/fneur.2022.886609. eCollection 2022.
- Pongratz G, Straub RH. The sympathetic nervous response in inflammation. Arthritis Res Ther. 2014;16(6):504. doi: 10.1186/s13075-014-0504-2.
- Bucsek MJ, Giridharan T, MacDonald CR, Hylander BL, Repasky EA. An overview of the role of sympathetic regulation of immune responses in infectious disease and autoimmunity. Int J Hyperthermia. 2018 Mar;34(2):135-143. doi: 10.1080/02656736.2017.1411621.
- Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
- Goodman BP, Khoury JA, Blair JE, Grill MF. COVID-19 Dysautonomia. Front Neurol. 2021 Apr 13;12:624968. doi: 10.3389/fneur.2021.624968. eCollection 2021.
- 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.
- 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.
- Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4.
- Scala I, Bellavia S, Luigetti M, Brunetti V, Broccolini A, Gabrielli M, Zileri Dal Verme L, Calabresi P, Della Marca G, Frisullo G. Autonomic dysfunction in non-critically ill COVID-19 patients during the acute phase of disease: an observational, cross-sectional study. Neurol Sci. 2022 Aug;43(8):4635-4643. doi: 10.1007/s10072-022-06136-2. Epub 2022 May 24.
- Sletten, David M., Guillermo A. Suarez, Phillip A. Low, Jay Mandrekar, and Wolfgang Singer. 2012. “COMPASS 31: A Refined and Abbreviated Composite Autonomic Symptom Score”. Mayo Clinic Proceedings. Elsevier BV. doi:10.1016/j.mayocp.2012.10.013.
- Vallee A. Dysautonomia and Implications for Anosmia in Long COVID-19 Disease. J Clin Med. 2021 Nov 25;10(23):5514. doi: 10.3390/jcm10235514.
- Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20. Erratum In: Diabetes Metab Syndr. 2022 May;16(5):102504. Diabetes Metab Syndr. 2022 Dec;16(12):102660.
- Jonathann Kuo, MD 2023. "Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05638620.
Frequently Asked Questions
Has the Active compound been verified by the FDA?
"Since this is a preliminary phase 1 trial, the safety of Active was estimated to be at level one due to limited data on their efficacy and security." - Anonymous Online Contributor
Are there any unfilled slots available in this research project?
"Affirmative. Per clinicaltrials.gov, this research initiative is actively accepting new participants. It was initially launched on December 1st 2022 and most recently amended on the same date, with a target of 20 patients at one single medical centre." - Anonymous Online Contributor
Do I satisfy the qualifications to enroll in this clinical experiment?
"This clinical trial seeks 20 individuals, ranging between 18 to 100 years of age, who are suffering from dysautonomia. Qualifying patients must have had a confirmed COVID-19 diagnosis by RT-PCR or equivalent testing and display lingering symptoms four weeks after the start of the infection. The COMPASS-31 is used to quantify autonomic symptom domains such as Orthostatic Intolerance and Vasomotor Alterations while PROMIS-29 measures patient reported pain interference or intensity." - Anonymous Online Contributor
Does this research permit elderly participants?
"The most recent review of the inclusion criteria specifies that patients must fall between 18-100 years old in order to participate. Separately, there are 947 separate clinical trials designed for minors and 3088 specifically tailored towards seniors." - Anonymous Online Contributor