CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Bupivacaine Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05664711
NCT05664711Phase 1Completed
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Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites

Neuroversion, Inc.·interventional·Posted Dec 27, 2022·Updated Dec 6, 2024

In Brief

A Phase 1 clinical trial evaluating Bupivacaine Injection for Encephalomyelitis, Myalgic and 8 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalomyelitis, 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
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedDec 27, 2022
Enrollment StartMar 15, 2023
Primary CompletionDec 21, 2023
Study CompletionJan 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.5 years ago

Interventions

Bupivacaine Injectiondrug

Reciprocal 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.