Clinical Trials Directory

Trials / Completed

CompletedNCT05664711

Effect of Stellate Ganglion Block on ME/CFS

Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Neuroversion, Inc. · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBupivacaine InjectionReciprocal unilateral stellate ganglion blocks, separated by at least 16 hours, will be given once per week for three weeks (for a total of 6 blocks). This study is not intended to be reported to FDA as a well-controlled study in support of a new indication for bupivacaine or to support any other significant change in the labeling for the drug.

Timeline

Start date
2023-03-15
Primary completion
2023-12-21
Completion
2024-01-15
First posted
2022-12-27
Last updated
2024-12-06

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05664711. Inclusion in this directory is not an endorsement.