MedTrace Logo

Effect of Stellate Ganglion Block on ME/CFS

NCT05664711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-06

No results posted yet for this study

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

  • 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

Interventions

DRUG

Bupivacaine Injection

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.

Sponsors & Collaborators

  • Neuroversion, Inc.

    lead OTHER

Principal Investigators

  • Deborah L Duricka, PhD · Neuroversion, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2023-12-21
Completion
2024-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664711 on ClinicalTrials.gov