A Phase 1 interventional study of Bupivacaine Injection in Encephalomyelitis, Myalgic, Chronic Fatigue Syndrome and Chronic Fatigue Disorder, sponsored by Neuroversion, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Neuroversion, Inc. · Phase 1, Interventional, and Treatment
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.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →This is the only study on the registry with Neuroversion, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The stellate ganglion and nearby cervical sympathetic ganglia will be blocked with 10 mL 0.5 percent bupivacaine under ultrasound guidance.
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.
Also known as: stellate ganglion block
Change in Subjective Rating of Symptoms at 2 Weeks
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two weeks for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).
Time frame: 2 weeks
Change in Subjective Rating of Symptoms at 2 Months
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two months for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).
Time frame: 2 months
Change in Cognitive Function at 2 Weeks
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces "brain fog" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two weeks post-treatment.
Time frame: 2 weeks
Change in Cognitive Function at 2 Months
The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces "brain fog" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two months post-treatment.
Time frame: 2 months
Change in Orthostatic Tolerance at 2 Weeks
The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 weeks post-treatment.
Time frame: 2 weeks
Change in Orthostatic Tolerance at 2 Months
The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 months post-treatment.
Time frame: 2 months
Change in Autonomic Tone at 2 Weeks
A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two weeks after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka "autonomic tone"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation.
Time frame: 2 weeks
Change in Autonomic Tone at 2 Months
A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two months after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka "autonomic tone"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation compared to baseline.
Time frame: 2 months
Change in Salivary Cortisol upon Awakening at 2 Weeks
Concentration of free cortisol in saliva upon awakening will be measured in micrograms per deciliter (ug/dL) using Enzyme-Linked Immunosorbent Assay (ELISA), at baseline and two weeks after treatment. ME/CFS patients have abnormally low levels of cortisol in general and upon awakening. An increased concentration within the normal range (from 0.007 ug/dL to 0.115 ug/dL) indicates a better outcome.
Time frame: 2 weeks
Change in Salivary Cortisol Upon Awakening at 2 Months
Concentration of free cortisol in saliva upon awakening will be measured in micrograms per deciliter (ug/dL) using Enzyme-Linked Immunosorbent Assay (ELISA), at baseline and two months after treatment. ME/CFS patients have abnormally low levels of cortisol in general and upon awakening. An increased concentration within the normal range (from 0.007 ug/dL to 0.115 ug/dL) indicates a better outcome.
Time frame: 2 months
Change in Metabolites at 2 Weeks
Plasma will be analyzed by liquid chromatography/mass spectrometry (LC/MS) to determine the levels of 433 hydrophilic metabolites (relative to an unchanging molecule in plasma) at baseline and at two weeks after treatment. ME/CFS patients are known to have abnormally high or low amounts of many metabolites, indicating mitochondrial dysfunction. Changes in abnormal metabolites toward normal values would indicate a better outcome.
Time frame: 2 weeks
Change in Metabolites at 2 Months
Plasma will be analyzed by liquid chromatography/mass spectrometry (LC/MS) to determine the levels of 433 hydrophilic metabolites (relative to an unchanging molecule in plasma) at baseline and at two months after treatment. ME/CFS patients are known to have abnormally high or low amounts of many metabolites, indicating mitochondrial dysfunction. Changes in abnormal metabolites toward normal values would indicate a better outcome.
Time frame: 2 months
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2023 to primary completion in Dec 2023, 9 months.
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Studies of the drug tested here: Bupivacaine