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Recruiting NCT05664711

Effect of Stellate Ganglion Block on ME/CFS

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

Sex: Female
Ages: 18 Years – 50 Years
Phase: PHASE1
Enrollment: 10
Sponsor: Neuroversion, Inc.

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Age (18-50 years)FemaleME/CFS (CCC and IOM criteria) duration less than 4 years at time of study enrollmentConfirmed or suspected viral disease prior to ME/CFS onset (e.g., SARS-CoV-2, Epstein-Barr, Influenza)BMI =18-29 kg/m^2Ability to read, write and speak English languageExclusion Criteria:Prior SGB treatmentAllergy to amide local anesthetics (e.g. ropivacaine, bupivacaine)Current anticoagulant useHistory of bleeding disorderHistory of glaucomaInfection or mass at injection siteAnatomical abnormalities in C3-T1 regionCurrent pregnancyHypertensionDiabetes (any type)Thyroid diseaseHistory of neck or throat surgeriesVocal cord problems or paralysisCausalgia/Chronic Regional Pain Syndrome (CRPS)Current cancer diagnosisDiagnosis of Guillain-Barré syndromeDiagnosis of current moderate or severe substance use disorderHistory of neurological disease, seizure, or significant head traumaConditions 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05664711). StuddyBuddy aggregates publicly available trial information.