Effect of Stellate Ganglion Block on ME/CFS (SGB_ME)

Neuroversion

Status and phase: Completed; Phase 1

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue-Fibromyalgia Syndrome; Infectious Mononucleosis-Like Syndrome, Chronic; Systemic Exertion Intolerance Disease; Chronic Fatigue Disorder; Chronic Fatigue Syndrome; Encephalomyelitis, Myalgic; Chronic Fatigue and Immune Dysfunction Syndrome; Postviral Fatigue Syndrome

Treatments: Drug: Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05664711

20193104

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age (18-50 years)
• Female
• ME/CFS (CCC and IOM criteria) duration less than 4 years at time of study enrollment
• Confirmed or suspected viral disease prior to ME/CFS onset (e.g., SARS-CoV-2, Epstein-Barr, Influenza)
• BMI =18-29 kg/m^2
• Ability to read, write and speak English language

Exclusion criteria

• Prior SGB treatment
• Allergy to amide local anesthetics (e.g. ropivacaine, bupivacaine)
• Current anticoagulant use
• History of bleeding disorder
• History of glaucoma
• Infection or mass at injection site
• Anatomical abnormalities in C3-T1 region
• Current pregnancy
• Hypertension
• Diabetes (any type)
• Thyroid disease
• History of neck or throat surgeries
• Vocal cord problems or paralysis
• Causalgia/Chronic Regional Pain Syndrome (CRPS)
• Current cancer diagnosis
• Diagnosis of Guillain-Barré syndrome
• Diagnosis of current moderate or severe substance use disorder
• History of neurological disease, seizure, or significant head trauma
• Conditions or disorders (other than ME/CFS) that affect cognitive functioning including stroke, past or present diagnosis of psychosis or psychotic symptoms, diagnosis of bipolar I disorder, or severe depression

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stellate Ganglion Block

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Injection