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Research Studies

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), as well as other fatigue related illnesses are poorly understood.  Individuals can have severe, long-lasting fatigue, which cannot be properly explained through extensive diagnostic procedures. Our research partnership with the CDC, Miami VA, NIH, other universities and Private Institutions furthers the understanding in the medical community as to how these illnesses affect their patients and could be used to develop a better understanding for improved health care. 

While there is no direct benefit from participating in some of the below research studies, your participation will be contributing to the knowledge and understanding of these illnesses.  With your help, people with ME/CFS or other fatiguing illnesses may be better treated in the future. We thank you in advance for your participation and continued support.

Gulf War Illness Research Studies and Trials

For more information please contact us at:
305-575-7648 or email VHAMIAGWI@VA.gov
In this study, we are interested in better understanding the causes of Gulf War illness symptoms. We are currently recruiting Veterans with Gulf War illness as well as healthy Gulf War-era Veterans.

In this study we are using microarray, a technique which measures expression levels of large numbers of genes, to help better understand and identify the likely causes of Gulf War illness. This method allows researchers to study different genes that affect how the body reacts to rest and exercise and how these differences affect the immune system, endocrine system, and brain. Location: Miami VA Medical Center & University of Miami. We are currently recruiting Women Veterans with Gulf War illness and as well as Women Gulf War-era sedentary Veterans.

This is a systematic assessment and characterization of the therapeutic effects of drugs that impact a specific list of therapeutic targets and are based on prior research. This is study is located at Miami VA Medical Center. We are currently recruiting Veterans with Gulf War Illness and Gulf War era healthy controls.

Two natural supplements (Curcumin and Glutathione) have been shown to quiet inflammation. In this study, researchers will test to see which supplements, if any, are beneficial in Gulf War illness. This study is located at the Miami VA Medical Center. We are currently recruiting Veterans with Gulf War Illness between 35-70 years of age.

Purpose of this study is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War illness. We are Located at the Miami VA Medical Center, VA Boston Healthcare System, Minneapolis VA Health Care System, and the James J. Peters VA Medical Center. We are currently recruiting all Gulf War Veterans.

Purpose of this study is to test the safety, effectiveness, and biological response to two medications (Entanercept followed by Mifepristone) in changing your bodies sick responseof GWI into a more permanently healthy condition. This study is located at the Miami VA Medical Center. We are currently rrecruiting Male Veterans with Gulf War Illness between 45-70 years of age.

Institute for Neuro-Immune Medicine Research Studies

We are currently recruiting ME/CFS patients AND Healthy Controls for this completely web based study to create a one of a kind genetic database for individuals with ME/CFS. 

Click here for more information!

Past Research Studies

The INIM conducted a Multi-site research study on behalf of the CDC to better understand the nature of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with the ultimate goal of improving quality of care available to ME/CFS patients. These studies were conducted at the INIM's Kendall and Davie locations. Below are the different groups who participated in the study.

  • ME/CFS Group

Participants enrolled were diagnosed with ME/CFS or Post-Infective Fatigue (PIF), between the ages of 18 and 70 years old and diagnosed with their illness prior to age 62.

  • Healthy Control Group

Participants enrolled were healthy controls NOT diagnosed with ME/CFS, Fibromyalgia, or PIF and between the ages of 18 and 70.  In addition, participants could not be living with someone diagnosed with ME/CFS.

  • Illness Comparison Group

Participants enrolled were diagnosed with Fibromyalgia, between the ages of 18 and 70 years old and were NOT diagnosed with ME/CFS, HIV or Dementia.

  • Homebound Group

Participants enrolled were diagnosed with ME/CFS or Post-Infective Fatigue (PIF) and were unable to leave their homes for office visits without severe consequences. Eligible participants were between the ages of 18 and 70 years old and diagnosed with their illness prior to age 62.

  • Incident Group

Participants enrolled were diagnosed with ME/CFS or PIF, between the ages of 18 and 70 years old, diagnosed prior to age 62 and had the onset of their illness within the past 2 years.

  • Pediatric Group

Participants enrolled were diagnosed with ME/CFS and Post-Infective Fatigue, between the ages of 10 and 17 years old.

  • Cognition and Exercise Study

Participants enrolled completed Stage 1 of the CDC ME/CFS study and were between the ages of 18 and 70 years old. 

The INIM conducted a Chronic Fatigue Syndrome Research Study in Men. Participants enrolled for this study had to meet the following criteria: 

  • Male
  • Between the ages of 18-65
  • Meet the following Criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine, and immune manifestations; and adhere to item 7:
    1. Fatigue: The patient must have a significant degree of new onset, unexplained, persistent, or recurrent physical and mental fatigue that substantially reduces activity level.
    2. Post-Exertional Malaise and/or Fatigue: There is an inappropriate loss of physical and mental stamina, rapid muscular and cognitive fatigability, post exertional malaise and/or fatigue and/or  pain  and  a  tendency  for  other  associated  symptoms  within  the  patient’s  cluster  of symptoms to worsen. There is a pathologically slow recovery period - usually 24 hours or longer.
    3. Sleep Dysfunction:* There is unrefreshed sleep or sleep quantity or rhythm disturbances such as reversed or chaotic diurnal sleep rhythms.
    4. Pain:* There is a significant degree of myalgia. Pain can be experienced in the muscles, and/or joints, and is often widespread and migratory in nature.  Often there are significant headaches of new type, pattern or severity.
    5. Neurological/Cognitive Manifestations: Two or more of the following difficulties should be present: confusion, impairment of concentration and short-term memory consolidation, disorientation,  difficulty  with  information  processing,  categorizing  and  word  retrieval,  and perceptual and sensory disturbances – e.g. spatial instability and disorientation and inability to focus vision. Ataxia, muscle  weakness and fasciculations are common. There may be overload  phenomena: cognitive, sensory – e.g. photophobia and hypersensitivity to noise - and/or emotional overload, which may lead to “crash” periods and/or anxiety.
    6. At Least One Symptom from Two of the Following Categories:
      • Autonomic Manifestations: orthostatic intolerance - neurally mediated hypotension (NMH), postural orthostatic tachycardia syndrome (POTS), delayed postural hypotension; light-  headedness; extreme pallor; nausea and irritable bowel syndrome; urinary frequency and bladder dysfunction; palpitations with or  without  cardiac arrhythmias; exertional dyspnea.
      • Neuroendocrine Manifestations: loss of thermostatic stability – subnormal body temperature and marked diurnal fluctuation, sweating episodes, recurrent feelings of feverishness and cold  extremities; intolerance of extremes of heat and cold; marked weight change - anorexia or abnormal appetite;  loss of adaptability and worsening of symptoms with stress.
      • Immune Manifestations: tender lymph nodes, recurrent sore throat, recurrent flu- like symptoms, general malaise, new sensitivities to food, medications and/or chemicals.

7. The illness persists for at least six months:  It usually has a distinct onset, although it may be   gradual.   Preliminary diagnosis may be possible earlier. Three months is appropriate for children

To be included: the symptoms must have begun or have been significantly altered after the onset of this illness. It is unlikely that a patient will suffer from all symptoms in criteria 5 & 6.  The disturbances tend to form symptom clusters that may fluctuate and change over time.   Children often  have  numerous prominent symptoms but their order of severity tends to vary from day to day.  There is a small number of patients who have no pain or sleep dysfunction, but no other diagnosis fits except ME/CFS. A diagnosis of ME/CFS can be entertained when this group has an infectious illness type onset.  Some patients have been unhealthy for other reasons prior to the onset of ME/ CFS and lack detectable triggers at onset or have more gradual or insidious onset.

Exclusions:  Exclude active disease processes that explain most of the major symptoms of fatigue, sleep disturbance, pain, and cognitive dysfunction.  It is essential to exclude certain diseases, which would be  tragic  to  miss:  Addison’s  disease,  Cushing’s  Syndrome,  hypothyroidism,  hyperthyroidism,  iron deficiency, other treatable forms of anemia, iron overload syndrome, diabetes mellitus, and cancer.  It is also  essential  to  exclude  treatable  sleep  disorders  such  as  upper  airway  resistance  syndrome  and obstructive  or  central  sleep  apnea;  rheumatological  disorders  such  as  rheumatoid  arthritis,  lupus, polymyositis and polymyalgia rheumatica; immune disorders such as AIDS; neurological disorders such as multiple sclerosis (MS), Parkinsonism, myasthenia gravis and B12 deficiency; infectious diseases such as tuberculosis, chronic hepatitis, Lyme disease, etc.; primary psychiatric disorders and substance abuse. Exclusion of other diagnoses, which cannot be reasonably excluded by the patient’s history and physical examination, is achieved by laboratory testing and imaging. If a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.

Co-morbid   Entities:   Fibromyalgia Syndrome (FMS), Myofascial Pain Syndrome (MPS), Temporomandibular Joint Syndrome (TMJ), Irritable Bowel Syndrome (IBS), Interstitial Cystitis, Irritable Bladder  Syndrome,  Raynaud’s  Phenomenon,  Prolapsed  Mitral  Valve,  Depression,  Migraine,  Allergies, Multiple Chemical Sensitivities (MCS), Hashimoto’s thyroiditis, Sicca Syndrome, etc. Such co-morbid entities may occur in the setting of ME/CFS. Others such as IBS may precede the development of ME/CFS by many years, but then become associated with it.  The same holds true for migraines and depression.  Their association is thus looser than between the symptoms within the syndrome.  ME/CFS and FMS often closely connect and should be considered to be “overlap syndromes”.

Idiopathic Chronic Fatigue: If the patient has unexplained prolonged fatigue (6 months or more) but has insufficient symptoms to meet the criteria for ME/CFS, classify it as idiopathic chronic fatigue.

The INIM conducted a Multi-site research study with Columbia University to: (1) determine how the intestinal, oral and blood microbiome of subjects with Chronic Fatigue Syndrome (CFS) differ from those of healthy control subjects; (2) examine the relationship of participants’ microbiomes to their clinical characteristics, including duration of illness and illness severity for subjects with CFS; (3) evaluate correlations of the microbiota with other biological measures obtained at multiple time points throughout the study. Below are the different groups who participated in the study.

  • ME/CFS Group

Participants enrolled were diagnosed with ME/CFS) and between the ages of 18 and 70 years old..

  • Healthy Control Group

Participants enrolled were healthy controls NOT diagnosed with ME/CFS and between the ages of 18 and 70 years old. 

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