Baraniuk Lab (original) (raw)

If you are interested in participating in our research, please contact:

  1. Email: gwiresearch@georgetown.edu

  2. Email: cfsresearch@georgetown.edu

  3. Phone: 202-687-8231

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Introduction

You are invited to take part in this study called Exercise in Gulf War Illness (GWI). You can participate if you were in the Armed Forces for at least 30 days between August 1, 1990 and July 31, 1991. You cannot take part if you are still Active Duty Military.

Study summary

Participants will spend about four (4) days in this study at the Georgetown University General Clinical Research Center (G-CRC). The objective is to find out if bicycle exercise stress tests on two (2) consecutive days lead to different reactions in GWI subjects compared to other veterans from the Gulf War era who do not have GWI (Healthy Veterans). Differences will be tested by exercise levels, blood tests, and brain scans using functional magnetic resonance imaging (fMRI). A lumbar puncture (LP; spinal tap) will be done so we can collect the fluid from around your brain and determine changes caused by the exercise. Our aim is to find new evidence of what goes wrong in the central nervous system (brain and spinal cord) in GWI.

Please take your time to make your decision. Discuss it with your family and friends. It is important that you read and understand several general principles that apply to all who take part in our studies:

  1. a.Taking part in the study is entirely voluntary
  2. b.Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained from your participation that will benefit others
  3. c.You may withdraw from the study at any time without any of the benefits you would have received normally being limited or taken away.

The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your rights as a participant, and other information about the study are discussed below. Any new information discovered, at any time during the research, which might affect your decision to participate or remain in the study will be provided to you. You are urged to ask any questions you have about this study with the staff members who explain it to you. You are urged to take whatever time you need to discuss the study with your physician, hospital personnel and your family and friends. It is your decision whether you do or do not participate. If you decide to participate, please sign and date where indicated at the end of this form.

The research is being sponsored by the Department of Defense (DOD). DOD is called the sponsor. Georgetown University is being paid by the DOD to conduct this study. James N. Baraniuk, M.D. is the person in charge of this research study (the primary or principal investigator).

This research study follows the directives of the U.S. Army Medical Research and Materiel Command (USAMRMC) Guidelines for Human Research (June 21, 2007) and its Guidelines for Investigators: Requirements for U.S. Army Medical Research and Materiel Command (USAMRMC) Headquarters Review and Approval of Research Involving Human Volunteers, Human Anatomical Substances, and/or Human Data under the guidance of the USAMRMC Human Research Protection Office (HRPO). As a volunteer, you must be aware that representatives of the USAMRMC have the authority to review research records. You have the right to decline to participate in this research study based on the DOD source of funding. You may NOT participate if you are Active Duty Military.

Why is the study being done?

You are being asked to participate in this study because you were enlisted in the military for at least 30 days during the Persian Gulf War of August 1, 1990 to July 31, 1991. You may have developed Gulf War Illness (GWI) or be healthy (healthy veteran). Participants with and without Gulf War Illness will be compared to better define GWI. This will help discover new methods for diagnosis and treatment.

Reasons Why you may not take part in this study (Exclusion Criteria)

You may not participate in this protocol if any of the following exclusion criteria apply to you:

  1. 1.HIV / AIDS subjects will be excluded. This infection alters many of the tests that will be part of this study. Everyone will have an HIV test. If your HIV test is positive, Dr. Baraniuk and the study team will contact you immediately. You will be immediately referred to your local primary care physician, infectious disease or other medical facility for follow-up and to start treatment.
  2. 2.Pregnant women will be excluded because of hormone effects and the fatigue that is common in pregnancy. Every woman will have a pregnancy test.
    1. Active duty military personnel
  4. 4.Children will be excluded because they are not old enough to have participated in the Persian Gulf War.
  5. 5.Incarcerated people (in jail) will be excluded because it is not fair to include them in this research study.
  6. 6.Cognitive impairment (problems thinking; brain fog) can make it difficult to understand this informed consent form, the questionnaires, and how to perform other parts of this study. If you have problems like this, then you cannot be in this study. However, we understand that problems concentrating, selecting the right word, and other issues are part of GWI. You will have a Mini-Mental Status exam and an interview with Dr. Baraniuk who will decide if you can join the study or not. You will be able to take part if you have GWI but do not have other thinking problem such as mental retardation, severe head injury, stroke, proven multiple sclerosis, melancholic suicidal major depression, schizophrenia, dementia, or other very serious neurological cause.
  7. 7.Brain injury. You will not be able to participate if you have had a severe head injury, bleeding into your brain, have been unconscious for more than 1 day (in a coma), have seizures, multiple sclerosis, dementia as in Alzheimer disease, the tremor and movement problems of Parkinson’s disease, or other nerve disorder.
  8. 8.Metal implants. The fMRI scanner uses magnets to measure blood flow in your brain. You will not be able to participate if you have any metal implants, prostheses, wires, plates, or screws in your body. The magnets are so strong that they can pull on the metal in your body and cause harm.
  9. 9.Claustrophobia. The fMRI scanner is narrow. Some people become anxious or agitated when they are in a small space. If you have this type of experience, then you should not take part in this study. Be sure you tell Dr. Baraniuk and his staff.
  10. 10.Abnormal laboratory and questionnaire results. Everyone will complete questionnaires, have blood work and other tests. We have set limits for these studies of blood, kidney, liver, blood pressure, heart, psychological status, and other measures that will allow you to be recruited into the study (inclusion criteria). If your results are outside these limits (exclusion criteria), then Dr. Baraniuk will decide if these values exclude you from the study. He and his study staff will help arrange for you to see your personal physician or another doctor to investigate abnormal test results.
  11. 11.Heart, lung, kidney, arthritis, autoimmune, cancer, and other chronic illnesses. You will be excluded if you can not perform the bicycle exercise stress tests. You will ride a bicycle to near your maximum ability, and at the same time breathe through a mouth piece to test your lung function. Some volunteers with leg amputations may not be able to perform the bicycle test. People with heart disease such as heart attacks (myocardial infarction), coronary artery disease, abnormal heart rhythms, uncontrolled high blood pressure or strokes will be excluded because the exercise may be too much of a strain for them. Subjects with lung disease from smoking or other causes may not be able to perform the exercise breathing part of the test. Painful, swollen or deformed joints related to arthritis or autoimmune diseases may not allow you to exercise. Weakness from nerve damage is different from the weakness related to GWI. Damage to other organs such as kidney disease on dialysis, liver disease (alcoholic cirrhosis), inflammatory bowel disease (Crohn’s disease, ulcerative colitis), or cancer will keep you out of the study. You may participate if you have well controlled diabetes or thyroid disease. Dr. Baraniuk will make the decision of whether these illnesses are under appropriate control so you can enter the study.
  12. 12.Medications. Drugs that interfere with heart, lung, brain and nerve function may have to be stopped or the dose decreased. Any changes will be made with the approval of your personal physician. If these types of drugs cannot be stopped, then you may not be able to take part in the study.
  13. 13.Problems Drawing Blood. Some people have very small veins that make it difficult to maintain intravenous lines for fluid replacement, or for drawing blood for tests. If you have small veins, or if it is difficult for nurses and doctors to draw your blood, then you should tell Dr. Baraniuk and his staff. It may be better to save your veins rather than have multiple needle sticks during this voluntary study.

The Purpose of this Study:

The purpose of this observational study is to find out if there are differences in the effects of exercise stress tests between GWI and healthy veterans. We will see if having two (2) bicycle stress tests on two (2) consecutive days will cause fatigue, pain, muscle weakness, difficulties solving problems, or brain function measured by fMRI brain scanning. Significant differences will help define the reasons why some people develop GWI.

Why is this clinical research study design being used?

This is an intensive in-hospital study with tests repeated on several days. This study design will check for differences between the first and the second set of tests you have. Some people may become more fatigued or weaker. Other people may have no changes. You will have a lumbar puncture (spinal tap) on the second last day of the study. Dr. Baraniuk and his team will work to discover the types of proteins and other brain chemicals that are associated with fatigue, pain, weakness, and thinking problems. This comparison type of study design is different from studies where you are tested once, or fill out questionnaires.