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Local Anesthetic

Stellate Ganglion Block for Chronic Fatigue Syndrome (SGB_ME Trial)

Phase 1

Waitlist Available

Led By Deborah L Duricka, PhD

Research Sponsored by Neuroversion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

SGB_ME Trial Summary

This trial will investigate if SGB can improve symptoms in people with ME/CFS, and if so, what changes in the body accompany those improvements.

Who is the study for?

This trial is for women aged 18-50 with ME/CFS lasting less than 4 years, a BMI of 18-29, and who had a viral disease before their ME/CFS. They must speak English and not be pregnant or have had certain neck surgeries, substance use disorders, SGB treatment before, severe mental health issues, hypertension, diabetes, vocal cord issues, CRPS, Guillain-Barré syndrome or allergies to local anesthetics.Check my eligibility

What is being tested?

The trial tests if stellate ganglion block (SGB) using Bupivacaine injections can improve symptoms like brain fog and fatigue in ME/CFS patients. It involves six injection sessions over three weeks and monitoring through surveys, cognitive tests plus blood/saliva analysis before and after treatment.See study design

What are the potential side effects?

Potential side effects from the Bupivacaine injection could include discomfort at the injection site; rare but serious risks may involve nerve damage or adverse reactions to the anesthetic.

SGB_ME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cognitive Function at 2 Months

Change in Cognitive Function at 2 Weeks

Change in Subjective Rating of Symptoms at 2 Months

+1 more

Secondary outcome measures

Change in Autonomic Tone at 2 Months

Change in Autonomic Tone at 2 Weeks

Change in Orthostatic Tolerance at 2 Months

+1 more

Other outcome measures

Change in Metabolites at 2 Months

Change in Metabolites at 2 Weeks

Change in Salivary Cortisol Upon Awakening at 2 Months

+1 more

SGB_ME Trial Design

1Treatment groups

Experimental Treatment

Group I: Stellate Ganglion BlockExperimental Treatment1 Intervention

The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine Injection

2017

Completed Phase 4

~580

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Neuroversion, Inc.Lead Sponsor

Deborah L Duricka, PhDPrincipal InvestigatorNeuroversion, Inc.

Media Library

Bupivacaine Injection (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05664711 — Phase 1

Chronic Fatigue Syndrome Research Study Groups: Stellate Ganglion Block

Chronic Fatigue Syndrome Clinical Trial 2023: Bupivacaine Injection Highlights & Side Effects. Trial Name: NCT05664711 — Phase 1

Bupivacaine Injection (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664711 — Phase 1

Chronic Fatigue Syndrome Patient Testimony for trial: Trial Name: NCT05664711 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol accepting participants aged 30 and up?

"This trial is open to adults between the ages of 18 and 50."

Answered by AI

To what extent might Stellate Ganglion Block endanger patients?

"Taking into consideration the limited evidence available, Stellate Ganglion Block has been assessed by our team at Power to be of low risk and granted a score of 1."

Answered by AI

Are new volunteers being accepted for this scientific experiment?

"Presently, this clinical trial is not actively seeking patients. The study was initiated on 1/1/2023 and last updated on 12/21/2022 according to the details posted on clinicaltrials.gov. Nonetheless, there are over 1800 other studies currently in search of volunteer participants."

Answered by AI

What are the ultimate goals of this experiment?

"The primary aim of this two-week clinical trial is to analyse the Changes in Subjective Rating of Symptoms at 2 Months. Secondary objectives include gauging changes in Orthostatic Tolerance, Autonomic Tone, and Blood Oxidation both after a fortnight and once two months have passed since treatment began. To measure these metrics accurately, The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used for orthostatic tolerance while wearables such as rings worn on fingers paired with smartphones apps are employed for autonomic tone measurements over both time frames."

Answered by AI

Might I be eligible to participate in this trial?

"A total of 10 individuals between the ages 18 and 50, who have been diagnosed with chronic fatigue syndrome by both CCC and IOM criteria in less than three years prior to enrollment are eligible for this trial. Additionally, those admitted must demonstrate evidence of a viral illness preceeding their ME/CFS diagnosis (e.g., SARS-CoV-2, Epstein-Barr or Influenza), possess a BMI ranging from 18 - 29 kg/m^2 and be able to comprehend English language proficiently."

Answered by AI