Effect of Stellate Ganglion Block on ME/CFS (NCT05664711) | Clinical Trial Compass
CompletedPhase 1
Effect of Stellate Ganglion Block on ME/CFS
United States10 participantsStarted 2023-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Diagnosis of Guillain-Barré syndrome
* Diagnosis of current moderate or severe substance use disorder
* History of neurological disease, seizure, or significant head trauma
* Conditions 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Subjective Rating of Symptoms at 2 Weeks
Timeframe: 2 weeks
2
Change in Subjective Rating of Symptoms at 2 Months