Staci R Stevens

Purpose Individuals with Long COVID and myalgic encephalomyelitis are characterized by post-exertional neuroimmune exhaustion (PENE) that affects their daily functional abilities. The purpose of this study was to compare self-rated function and the associated burden of functioning in individuals with PENE associated with Long COVID and other causes...

Background Post-exertional malaise (PEM), the hallmark symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), represents a constellation of abnormal responses to physical, cognitive, and/or emotional exertion including profound fatigue, cognitive dysfunction, and exertion intolerance, among numerous other maladies. Two sequential c...

Patients with Myalgic Encephalomyelitis (ME) have diminished exercise performance, work output, and lower oxygen consumption in the post-exertional state. PURPOSE: To test whether reductions in ventilatory responses contribute to impaired exercise performance. METHODS: Maximal exercise tests were performed on sequential days using a cycle ergomet...

Background and Objectives: Post-exertional malaise (PEM) is the hallmark of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there has been little effort to quantitate the duration of PEM symptoms following a known exertional stressor. Using a Symptom Severity Scale (SSS) that includes nine common symptoms of ME/CFS, we sought to ch...

Background: Existing instruments often are inappropriate to measure the effects of post-exertional malaise (PEM) and post-exertional symptom exacerbation (PESE) on activities of daily living (ADLs). A validated questionnaire to measure self-reported ability with ADLs would advance research and clinical practice in conditions like myalgic encephalo...

Background: Post-exertional malaise (PEM) is the hallmark symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) yet its diverse manifestations make it difficult to recognize. Brief instruments for detecting PEM are critical for clinical and scientific progress. Objective: To develop a clinical prediction rule for PEM. Method:...

In the U.S., annual incidence of Lyme disease is approximately 300,000. In an estimated 5-30% of cases, post-treatment Lyme disease syndrome (PTLDS) develops; symptoms include post-exertional malaise characteristic of myalgic encephalomyelitis. The contribution of autonomic regulation has not been elucidated. PURPOSE: To evaluate cardiovascular res...

Fibromyalgia syndrome (FMS) affects nearly 10 million people in the United States and an estimated 6% of the world’s population. FMS is idiopathic and characterized by severe pain (typically in joints and musculature), fatigue, and malaise. Pain and fatigue may limit physical activity, but other factors such as post-exertional malaise, may also con...

Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) causes significant impairment in daily activities, including the ability to pursue daily activities. Chronotropic intolerance is becoming better characterized in ME/CFS and may be the target of supportive treatment. Objective: To document the effect of repeated intravenous (...

Background: Diminished cardiopulmonary exercise test (CPET) performance indicates the physiological basis for reduced capacity for activities of daily living and work. Thus, it may be a biomarker for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Objective: To determine statistical properties of cardiac, pulmonary, and metabolic me...

Background: Post-exertional malaise (PEM) is an exacerbation of symptoms that leads to a reduction in functionality. Recognition of PEM is important for the diagnosis and treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Objective: Symptoms following cardiopulmonary exercise testing were compared between ME/CFS patients a...

Abstract Purpose: Measurements obtained during maximal cardiopulmonary exercise testing (CPET) demonstrate high test–retest reliability, which indicates low error variance. However, measurements obtained from people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) may depart from typically observed high reproducibility, which could...

Purpose Measurements obtained during maximal cardiopulmonary exercise testing (CPET) demonstrate high test–retest reliability, which indicates low error variance. However, measurements obtained from people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) may depart from typically observed high reproducibility, which could represent...

Post-exertional malaise (PEM) is the hallmark clinical feature of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). PEM involves a constellation of substantially disabling signs and symptoms that occur in response to physical, mental, emotional, and spiritual over-exertion. Because PEM occurs in response to over-exertion, physiological m...

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a syndrome of unknown etiology characterized by profound fatigue exacerbated by physical activity, also known as post-exertional malaise (PEM). Previously, we did not detect evidence of immune dysregulation or virus reactivation outside of PEM periods. Here we sought to determine whet...

Background: Concise methodological directions for administration of serial cardiopulmonary exercise testing (CPET) are needed for testing of patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Maximal CPET is used to evaluate the coordinated metabolic, muscular, respiratory and cardiac contributions to energy production in pa...

Reduced functional capacity and post-exertional malaise following physical activity are hallmark symptoms of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The mechanisms producing exercise intolerance in the post-exertional state have not been adequately described. PURPOSE: To compare the ventilatory response to repeated exercise str...

Objectives Reduced functional capacity and post-exertional fatigue following physical activity are hallmark symptoms of chronic fatigue syndrome (CFS) and may even qualify for biomarker status. That these symptoms are often delayed may explain the equivocal results for clinical cardiopulmonary exercise testing among individuals with CFS. Test repro...

Eur J Clin Invest 2012; 42 (12): 1362

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue. The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C(12)U), in patients with debilitating CFS/ME. A Phase III pr...

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Clinical Trial Sites, Principal Investigators, and IRB. (DOC)

Clinical Significance of Karnofsky Performance Scale Scores. (DOC)

Comparison of Intra-Group Mean ET Improvement Seen With Rintatolimod (PolyI:C12U) vs. Approved Drugs for Non-CFS Severe Exertional Fatigue. (DOC)

Treadmill Exercise Testing Protocol. (DOC)

Demographic Characteristics of the Rintatolimod (Poly I:C12U) versus Placebo Cohorts. (DOC)

Concomitant Medications Used for CFS Symptoms. (DOC)

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All Adverse Events Experienced by at Least 5% of Subjects in Either Treatment Group during the First 40 Weeks (Safety Population). (DOC)

Chronological Listing of Stage I Serious Adverse Events (SAEs). (DOC)

Requirements for Entry into the Phase-III AMP-516 Clinical Study. (DOC)

The purpose of this investigation was to identify significant quality-of-life issues for two women previously diagnosed with chronic fatigue syndrome (CFS), and their families. Both women were participants in a cost-recovery, clinical trial of the antiviral and immuno-modulatory drug, Ampligen. A qualitative, case study approach was adopted to acce...

To determine the diagnostic accuracy for single symptoms and clusters of symptoms to distinguish between individuals with and without chronic fatigue syndrome (CFS).  A cohort study was conducted in an exercise physiology laboratory in an academic setting. Thirty subjects participated in this study (n = 16 individuals with CFS; n = 14 non-disabled...

The label 'chronic fatigue syndrome' (CFS) has persisted for many years because of the lack of knowledge of the aetiological agents and the disease process. In view of more recent research and clinical experience that strongly point to widespread inflammation and multisystemic neuropathology, it is more appropriate and correct to use the term 'myal...

To determine the validity and reliability of Short Form 36 Version 2 (SF36v2) in sub-groups of individuals with fatigue. Thirty subjects participated in this study, including n = 16 subjects who met case definition criteria for chronic fatigue syndrome (CFS) and n = 14 non-disabled sedentary matched control subjects. SF36v2 and Multidimensional Fat...

Most research points to cognitive slowing in chronic fatigue syndrome (CFS), although there have been negative reports. The present study is one of few that examines fine motor processing and the inhibition of automatic responses in a well-characterised CFS population. A total of 35 female CFS patients without current major depression and 25 female...

Postexertional malaise (PEM) is a defining characteristic of chronic fatigue syndrome (CFS) that remains a source of some controversy. The purpose of this study was to explore the effects of an exercise challenge on CFS symptoms from a patient perspective. This study included 25 female CFS patients and 23 age-matched sedentary controls. All partici...

Fatigue is one of the most common reasons why people consult health care providers. Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is one cause of clinically debilitating fatigue. The underdiagnosis of CFS/ME, along with the spectrum of symptoms that represent multiple reasons for entry into physical therapy settings, places physical t...

Reduced functional capacity and post-exertional malaise following physical activity are hallmark symptoms of Chronic Fatigue Syndrome (CFS). That these symptoms are often delayed may explain the equivocal results for clinical cardiopulmonary exercise testing with CFS patients. The reproducibility of VO2 max in healthy subjects is well documented. T...

A reduction in peak oxygen consumption (VO2 max) between two maximal exercise tests administered over a two-day period has been suggested as a metabolic abnormality that is unique to chronic fatigue syndrome (CFS). The reduction in VO2 max of 27% observed in preliminary studies may be due to lowered blood volume from either dehydration or abnormal...

This article examines the legal and scientific bases on which an exercise stress test can provide medically acceptable evidence of disability for the Chronic Fatigue Syndrome (CFS) patient. To qualify for disability benefits, a claimant must establish the existence of a seri-ous medically determinable impairment (MDI) that causes the inability to w...

Reduced functional capacity and post-exertional malaise following physical activity are hallmark symptoms of Chronic Fatigue Syndrome (CFS). That these symptoms are often delayed may explain the equivocal results for clinical cardiopulmonary exercise testing (GXT) with CFS patients. The reproducibility of VO2max in healthy subjects is well document...

Clinical cardiopulmonary exercise testing suggests that the diminished physical working capacity in Chronic Fatigue Syndrome (CFS) is associated in part with a blunted cardiovascular response. This could be linked to of low blood volume or an abnormal autonomic responsiveness to stress, both of which have been documented in CFS. Administration of i...

Reduced functional capacity following physical activity is a hallmark symptom of Chronic Fatigue Syndrome (CFS). While it is hypothesized that this post-exertional malaise may result from impaired aerobic metabolism, current diagnoses rely mainly on self-report measures of symptom exacerbation and fatigue following physical activity. Purpose: This...

Hyperactivition of an unwanted cellular cascade by a protein (RNase L) central to immune function has been linked to reduced exercise capacity in persons with CFS. However, these findings may be confounded by a failure to adequately control for gender differences in exercise capacity when the results of exercise testing are a primary outcome measur...

Hyperactivition of an unwanted cellular cascade by the immune-related protein RNase L has been linked to reduced exercise capacity in persons with chronic fatigue syndrome (CFS). This investigation compares exercise capacities of CFS patients with deregulation of the RNase L pathway and CFS patients with normal regulation, while controlling for pot...

The purpose of this study was to examine physiological responses of persons with chronic fatigue syndrome (CFS) to a graded exercise test. Cardiopulmonary exercise tests were performed on 189 patients diagnosed with CFS. Based on values for peak oxygen consumption, patients were assigned to one of four impairment categories (none, mild, moderate, a...

The physiological response to exercise has the potential to provide important insights into the underlying pathogenic mechanisms of CFS. However, studies employing exercise testing with CFS patients are often plagued with problems of small sample sizes which may be the result of many CFS patients being unwilling or unable to fulfill traditional cri...

The state of chronic immune activation observed in many individuals with CFS may be linked to the low exercise tolerance and functional impairment that typify this disease. Defects in the dsRNA-dependent, interferon-inducible 2'-5'A/RNase L antiviral defense pathways have been implicated in these clinical and immunological abnormalities. PURPOSE: T...

The elevated RNase L enzyme activity observed in some Chronic Fatigue Syndrome (CFS) patients may be linked to the low exercise tolerance and functional impairment that typify this disease. The purpose of this investigation was to determine if specific indicators of physical performance can predict abnormal RNase L activity in CFS patients. Seventy...

Functional impairment in a population of patients with chronic fatigue syndrome (CFS) was determined by exercise testing. The criteria established by Weber and Janicki (1) were employed because impairment levels are based on maximal oxygen consumption. Oxygen consumption was obtained by cardiopulmonary exercise testing and was used to classify subj...

The purpose of this investigation was to identify significant quality-of-life issues for two women previously diagnosed with chronic fatigue syndrome (CFS), and their families. Both women were participants in a cost-recovery, clinical trial of the antiviral and immuno-modulatory drug, Ampligen.A qualitative, case study approach was adopted to acces...

Chronic Fatigue Syndrome (CFS) is a complex illness characterized by pervasive fatigue, sleep disturbance, neurocognitive problems, joint and muscle pain and numerous other symptoms. Persons with the illness face functional impairment that has not yet been clearly characterized. Because CFS is an emerging illness, there are few guidelines for the e...

Chronic Fatigue Syndrome (CFS) is a complex illness characterized by pervasive fatigue, sleep disturbance, neurocognitive problems, joint and muscle pain and numerous other symptoms. Persons with the illness face functional impairment that has not yet been clearly characterized. Because CFS is an emerging illness, there are few guidelines for the e...