Effect of Stellate Ganglion Block on ME/CFS

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.