Understanding different types of fatigue

Patient-Centered Assessment of Symptoms and Outcomes

This study is trying to understand the different types of fatigue by looking at people who feel very tired and comparing them to healthy volunteers to see what might be causing their fatigue.

Quick facts

• Study type: Observational
• Enrollment: 692 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03952624 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize and phenotype individuals experiencing clinically-meaningful fatigue, regardless of the underlying condition. Participants will undergo a series of assessments, including interviews, questionnaires, physical tests, and biological sample collection, to explore the heterogeneity of fatigue symptoms. The study will involve up to 692 participants, including both fatigued individuals and healthy volunteers, to generate hypotheses about the mechanisms behind different fatigue dimensions. The research will provide insights into the biological correlates of fatigue and may help in developing targeted therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced fatigue for more than a month, as well as healthy volunteers.

Not a fit: Patients with acute complications of medical diseases or psychiatric conditions that impair their ability to report fatigue may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and treatment options for patients suffering from various forms of fatigue.

How similar studies have performed: While the approach of characterizing fatigue is not widely tested, similar studies have shown promise in understanding complex symptoms in various conditions.

Eligibility criteria

* 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

EXCLUSION CRITERIA:

Exclusion from study entry:

* Not fluent in English.
* 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);
* 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.
* 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.
* 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).
* 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.
* Tilt Table Test

  --Beta blocker medications.
* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Miroslav Backonja, M.D. — National Center for Complementary and Integrative Health (NCCIH)
• Study coordinator: Alexander L Ross, R.N.

Conditions: Fatigue, Cancer, CFS, ME/CFS, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Lupus, Systemic Lupus Erthematosus, Sjogrens