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Protocol Details

Patient-Centered Assessment of Symptoms and Outcomes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-NR-0098

Sponsoring Institute

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking

Keywords

Symptom Biology;
Symptom Phenotyping;
Fatigue;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Fatigue;
Cancer;
CFS;
ME/CFS;
Myalgic encephalomyelitis/chronic fatigue syndrome;
Lupus;
Systemic Lupus Erthematosus;
Sjogrens

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Nursing Research

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.

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Eligibility

INCLUSION CRITERIA:

All Participants

-Adult participants aged greater than or equal to 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.

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 (greater than or equal to 5 drinks/day and greater than or equal to 15 drinks/week for men, greater than or equal to 4 drinks per day and greater than or equal to 8 drinks per 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 Stage 2 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 greater than or equal to 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.


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Citations:

Saligan LN, Olson K, Filler K, Larkin D, Cramp F, Yennurajalingam S, Escalante CP, del Giglio A, Kober KM, Kamath J, Palesh O, Mustian K; Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The biology of cancer-related fatigue: a review of the literature. Support Care Cancer. 2015 Aug;23(8):2461-78. doi: 10.1007/s00520-015-2763-0. Epub 2015 May 15. Review. Erratum in: Support Care Cancer. 2015 Sep;23(9):2853. Sriram, Yennu [corrected to Yennurajalingam, Sriram].

Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM R. 2010 May;2(5):384-92. doi: 10.1016/j.pmrj.2010.03.026.

Sharpe M, Wilks D. Fatigue. BMJ. 2002 Aug 31;325(7362):480-3.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
NIHBC 03 BG RM 5E14
3 CENTER DR
BETHESDA MD 20892
(301) 451-1685
saliganl@mail.nih.gov

Alexander Ross, R.N.
National Institute of Nursing Research (NINR)
National Institutes of Health
Building 10
Room 2-1339
10 Center Drive
Bethesda, Maryland 20892
(301) 841-5068
alexander.ross2@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03952624

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