NCT03952624Completed
Patient-Centered Assessment of Symptoms and Outcomes
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 15 May 2019
- Start date
- 13 Sept 2019
- Primary completion date
- 20 Apr 2026
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT03952624
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 13 Sept 2019 to the primary completion date, 20 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current substance use disorder within the last five years or positive urine toxicology results at enrollment and before Stage 2. Prior marijuana use within the past five years will not be an exclusion.
- Tilt Table Test
- --Beta blocker medications.
Other illness
- Have medical health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as unstable hypertension, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina.
- Have a psychiatric condition that prevents participant from being able to reliably report the fatigue experience (e.g., a psychotic disorder with severely disorganized thinking);
- Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study or safety of the participant.
- Exclusion from specific tests:
- fMRI Technical Development Sub-Study
- Implanted cardiac pacemakers, metal aneurysm clips;
- Broken bones repaired with metal pins, screws, rods, plates;
- Prosthetic eye implants;
- Transdermal medications or infusion pumps;
- Bullet fragments or other metal pieces in body from old wounds;
- Significant work exposure to metal particles;
- Clinically relevant claustrophobia;
- Unable to lie comfortably on back for up to 4 hours;
- Left-handed. (Participants that are ambidextrous, will complete the Edinburgh Handedness Inventory).
- CPET
- Any neuromuscular conditions (e.g., multiple sclerosis, Parkinson s disease) with significant mobility impairment that prohibits treadmill or bike performance, or any medical condition (e.g., congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease \[COPD\], severe osteoarthritis and poorly controlled asthma) that would make it risky for the participant to exercise (e.g., exercise-induced angina and asthma), will exclude a participant from the CPET.
Other
- Exclusion from study entry:
- Not fluent in English.
- Categorized as a high-risk drinker (\>=5 drinks/day and \>=15 drinks/week for men, \>=4 drinks/day and \>=8 drinks/week for women). ( Dietary Guidelines for Americans 2015-2020," U.S. Department of Health and Human Services and U.S. Department of Agriculture).
- NIH employees.
- Pregnant or lactating women.
- EEfRT and Stroop Test
- Severe essential hand tremor or severe hand pain (e.g., severe arthritis or severe carpel tunnel) that makes it difficult to perform rapid keyboard presses will be an exclusion from the EEfRT and Stroop Test.
- Color-blindness, verified by scoring \>14 on the Ishihara card test, will exclude a participant from taking the Stroop test. The Ishihara card test will be administered only if the participant states he or she is color-blind.
Criteria the registry did not label
- INCLUSION CRITERIA:
- All Participants (including returning participants)
- Adult participants aged \>= 18 years at the time of enrollment.
- Able to provide written informed consent.
- Willing and able to complete study procedures.
- Fatigued Participants
- -In addition to the above, must experience fatigue for more than a month.
- Healthy Volunteers for the fMRI study
- Right handed
- Not taking any prescribed medications for chronic medical conditions
- Not diagnosed with any chronic medical condition
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.