Actively Recruiting
Patient-Centered Assessment of Symptoms and Outcomes
Led by National Center for Complementary and Integrative Health (NCCIH) · Updated on 2026-05-01
692
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.
CONDITIONS
Official Title
Patient-Centered Assessment of Symptoms and Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants aged �3E= 18 years at the time of enrollment.
- Able to provide written informed consent.
- Willing and able to complete study procedures.
- Fatigued participants must have experienced fatigue for more than a month.
- Healthy volunteers for the fMRI study must be right handed, not taking prescribed medications for chronic conditions, and not diagnosed with chronic medical conditions.
You will not qualify if you...
- Not fluent in English.
- Medical health issues that create substantial risks related to study procedures, such as unstable hypertension, diabetic ketoacidosis, symptomatic hyperthyroidism, or unstable angina.
- Psychiatric conditions that prevent reliable reporting of fatigue (e.g., psychotic disorder with severely disorganized thinking).
- Current substance use disorder within the last five years or positive urine toxicology at enrollment and before Stage 2; prior marijuana use within five years is allowed.
- High-risk drinkers (>=5 drinks/day and >=15 drinks/week for men, >=4 drinks/day and >=8 drinks/week for women).
- NIH employees.
- Pregnant or lactating women.
- Ongoing medical conditions deemed by the Principal Investigator to interfere with study conduct or safety.
- For fMRI sub-study: implanted cardiac pacemakers or metal clips, metal hardware from broken bones, prosthetic eye implants, transdermal medications or infusion pumps, bullet fragments or metal pieces in the body, significant work exposure to metal particles, claustrophobia, inability to lie on back for up to 4 hours, left-handedness (ambidextrous allowed with inventory).
- For EEfRT and Stroop tests: severe essential hand tremor or severe hand pain that impairs rapid keyboard use; color blindness excluding Stroop test.
- For Tilt Table Test: use of beta blocker medications.
- For CPET: neuromuscular conditions with mobility impairment or medical conditions that make exercise risky (e.g., congestive heart failure, coronary artery disease, COPD, severe osteoarthritis, poorly controlled asthma, exercise-induced angina).
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Alexander L Ross, R.N.
CONTACT
M
Miroslav Backonja, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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