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Effect of Stellate Ganglion Block on ME/CFS

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender Female
More Inclusion & Exclusion 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-BarrĂ© 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05664711
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Neuroversion, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Deborah L Duricka, PhD
Principal Investigator Affiliation Neuroversion, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Stellate Ganglion Block

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Neuroversion, Anchorage, Alaska

Status

Recruiting

Address

Neuroversion

Anchorage, Alaska, 99508

Site Contact

Deborah L Duricka, PhD

[email protected]

907-339-4650

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