NCT05664711CompletedPhase 1
Effect of Stellate Ganglion Block on ME/CFS
Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 12 Dec 2022
- Start date
- 15 Mar 2023
- Primary completion date
- 21 Dec 2023
- Lead sponsor
- Neuroversion, Inc.
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05664711
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 15 Mar 2023 to the primary completion date, 21 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior SGB treatment
Other illness
- Allergy to amide local anesthetics (e.g. ropivacaine, bupivacaine)
- History of bleeding disorder
- History of glaucoma
- Infection or mass at injection site
- Hypertension
- Diabetes (any type)
- Thyroid disease
- History of neck or throat surgeries
- 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
Other
- Current anticoagulant use
- Anatomical abnormalities in C3-T1 region
- Current pregnancy
- Vocal cord problems or paralysis
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuroversion Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.