Clinical trial NCT05664711: Effect of Stellate Ganglion Block on ME/CFS
Official title: Effect of Stellate Ganglion Block on ME/CFS Symptoms and Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Keywords: ME/CFS
myalgic encephalomyelitis
chronic fatigue syndrome
stellate ganglion block
SGB
cervical sympathetic block
post-exertional malaise
PEM
exertional intolerance
brain fog
orthostatic intolerance
Lead sponsor: Neuroversion, Inc.
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Subjective Rating of Symptoms at 2 Weeks
timeFrame: 2 weeks
measure: Change in Subjective Rating of Symptoms at 2 Months
timeFrame: 2 months
measure: Change in Cognitive Function at 2 Weeks
timeFrame: 2 weeks
measure: Change in Cognitive Function at 2 Months
timeFrame: 2 months
Secondary outcomes:
measure: Change in Orthostatic Tolerance at 2 Weeks
timeFrame: 2 weeks
measure: Change in Orthostatic Tolerance at 2 Months
timeFrame: 2 months
measure: Change in Autonomic Tone at 2 Weeks
timeFrame: 2 weeks
measure: Change in Autonomic Tone at 2 Months
timeFrame: 2 months
Other outcomes:
measure: Change in Salivary Cortisol upon Awakening at 2 Weeks
timeFrame: 2 weeks
measure: Change in Salivary Cortisol Upon Awakening at 2 Months
timeFrame: 2 months
measure: Change in Metabolites at 2 Weeks
timeFrame: 2 weeks
measure: Change in Metabolites at 2 Months
timeFrame: 2 months
Locations:
city: Anchorage
country: United States
facility: Neuroversion
state: Alaska
Study officials:
affiliation: Neuroversion, Inc.
name: Deborah L Duricka, PhD
role: PRINCIPAL_INVESTIGATOR
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