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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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cognitive Function at 2 Months
Change in Cognitive Function at 2 Weeks
Change in Subjective Rating of Symptoms at 2 Months
+1 moreSecondary study objectives
Change in Autonomic Tone at 2 Months
Change in Autonomic Tone at 2 Weeks
Change in Orthostatic Tolerance at 2 Months
+1 moreOther study objectives
Change in Metabolites at 2 Months
Change in Metabolites at 2 Weeks
Change in Salivary Cortisol Upon Awakening at 2 Months
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Neuroversion, Inc.Lead Sponsor
Deborah L Duricka, PhDPrincipal InvestigatorNeuroversion, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of serious head injury or neurological problems.You have a history of stroke, severe depression, bipolar I disorder, or psychosis.You are currently diagnosed with a serious problem of using drugs or alcohol.You have an infection or lump at the place where the injection will be given.You have been diagnosed with ME/CFS for less than 4 years.You have received SGB treatment before.You have high blood pressure.You have diabetes, no matter what type.You have a condition called causalgia or Chronic Regional Pain Syndrome (CRPS).You have been diagnosed with Guillain-Barré syndrome.You are allergic to certain types of local anesthesia, like ropivacaine or bupivacaine.You are currently taking blood thinners.You have a history of a disorder that causes bleeding.You have had glaucoma in the past.You have physical irregularities in the C3-T1 region of your body.You have a thyroid disease.You are between 18 and 50 years old.You have had a viral illness like COVID-19, Epstein-Barr, or the flu before developing ME/CFS.Your body mass index (BMI) is between 18 and 29.You have issues with your vocal cords or they are paralyzed.You have cancer right now.Your body mass index (BMI) is between 18 and 29.
Research Study Groups:
This trial has the following groups:- Group 1: Stellate Ganglion Block
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Fatigue Syndrome Patient Testimony for trial: Trial Name: NCT05664711 — Phase 1
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