Exertional Exhaustion in Chronic Fatigue Syndrome
Launched by GEORGETOWN UNIVERSITY · Jun 21, 2018
Trial Information
Current as of June 19, 2025
Completed
Keywords
ClinConnect Summary
Chronic Fatigue Syndrome (CFS) and sedentary control subjects answered on-line advertisements and word-of-mouth communications. Candidates gave verbal informed consent to discuss their medical history during a telephone interview. If the met inclusion and exclusion criteria, they were assigned an log-in code and password to complete an extensive on-line questionnaire, and were scheduled for the 3 day in-patient study.
On the Screening Day subjects completed written informed consent, history and physical, screening blood work, mental status exam, heart rate variability for orthostasis, and ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • CFS and healthy subjects
- Exclusion Criteria:
- • HIV / AIDS subjects
- • Pregnant women
- • Lactation
- • Cognitive impairment, mental retardation, severe head injury, stroke, proven multiple sclerosis, "melancholic" suicidal major depression, schizophrenia, Alzheimer's disease, "mild cognitive impairment" (MCI), other dementia, or other serious neurological diseases
- • Brain injury. stroke, severe head injury (concussion, severe motor vehicle accidents), bleeding into brain, have been unconscious for more than 1 day (in a coma), seizures, brain inflammation such as multiple sclerosis or lupus.
- • Metal implants such as prostheses, wires, plates, or screws that may heat up in the magnetic resonance imaging scanner and cause harm.
- • Claustrophobia.
- • Abnormal laboratory and questionnaire results.
- • Heart, lung, kidney, arthritis, autoimmune, cancer, and other chronic illnesses, leg amputations heart attacks (myocardial infarction), coronary artery disease, abnormal heart rhythms, congestive heart failure, heart valve disease, uncontrolled high blood pressure or strokes, lung disease from smoking or other causes, painful, swollen or deformed joints related to arthritis or autoimmune diseases, weakness from nerve damage, kidney disease on dialysis, liver disease (alcoholic cirrhosis, hepatitis B, hepatitis C), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or cancer Subjects may participate if they have well-controlled diabetes or thyroid disease.
- • Any other chronic disease with chronic pain, fatigue and thinking problems (cognitive impairment) that would limit the ability to complete the questionnaires and other tests.
- • Amputation that would prevent bicycle exercise.
- • Medications. Drugs that interfere with heart, lung, brain and nerve function
- • Drinking and Smoking. You will have to stop caffeine (coffee, tea, soft drinks), alcohol, cannabis and nicotine products (smoking) for 3 days before the study, and the full period of the testing.
- • Difficulties Drawing Blood.
- • Children under the age of 18 years
- • Incarcerated people (in jail)
- • Alcohol or substance abuse in the past 6 months.
- • English: Subjects must be able to speak and understand English to be able to understand the tests and other instructions during the study.
- • Disruptive: Subjects who are disruptive or may reveal medical information about other subjects will be excluded.
About Georgetown University
Georgetown University is a prestigious academic institution renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Georgetown University leverages its extensive resources and expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among multidisciplinary teams, emphasizing ethical practices and adherence to regulatory standards. With a focus on translating scientific discoveries into clinical applications, Georgetown University plays a vital role in enhancing patient care and contributing to the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Kristen Katopol
Study Chair
IRB Director
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials