Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04263454 |
Other study ID # |
IRB-140930002 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
March 11, 2020 |
Est. completion date |
December 22, 2021 |
Study information
Verified date |
March 2023 |
Source |
University of Alabama at Birmingham |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The major goal of this study is to determine if the innate immune response is dysregulated in
people with fibromyalgia, compared to healthy controls. Magnetic resonance spectroscopy will
be used to measure changes in the brain's metabolic profile following an experimental immune
stimulus, to test whether individuals with fibromyalgia show a heightened immune response in
the brain. The ultimate goal of this research is to better understand the role of brain
inflammation in the pathophysiology of chronic pain and fatigue, which will guide the
development of more effective therapies for these conditions.
Description:
The study consists of two sessions: the screening session and the experimental session.
During the initial phone screening, individuals who contact the study team will be given
information about the study, including a description of all study-related procedures. If
interested, participants will then be taken through a phone screen interview that will ask
them to report demographic information (date of birth, race, ethnicity), height and weight,
and list of medical conditions and current medications, surgical history within the past
year, amount of weekly consumption of alcohol, tobacco products, and illicit substances,
viral or bacterial infections within the past 3 months, recent vaccines received, and current
participation in other research. The standard MRI Safety form will be administered to ensure
participants do not have ferromagnetic implants or other contraindications to MRI (e.g.
claustrophobia).A self-report will also be administered to ascertain that potential
fibromyalgia participants meet 2016 American College of Rheumatology (ACR) criteria for
fibromyalgia. The phone screen is intended to reduce participant burden by identifying
exclusion criteria without the need to attend at UAB. Participants who meet initial screening
criteria will be invited to attend an in-person screening visit.
During the screening visit, participants will go to the Clinical Research Unit (CRU) on the
15th floor of Jefferson Tower. Participants will be asked to fast prior to this visit.
Participants will provide written informed consent before any study procedures are initiated.
Participants will provide a urine sample for pregnancy testing. Vital signs (blood pressure,
heart rate), aural temperature, height and weight will be measured and recorded. Participants
will undergo 12-lead electrocardiogram and provide a maximum of 60cc of blood into labeled
blood collection tubes for screening tests. A tender point exam will be administered to
assess fibromyalgia symptomatology. The procedure uses a pressure algometer, a hand-held
instrument with a small rubber tip that is applied to the participant's skin over
standardized regions of the body (occipital, low cervical, upper trapezius, supraspinatus,
anterior second rib, lateral epicondyle, gluteal, greater trochanteric, or medial knee).
Pressure is slowly increased at a constant rate until the participant reports the sensation
changing from one of pressure to one of pain or discomfort. Participants will complete a
demographics form , Brief Pain Inventory, Fibromyalgia Impact Questionnaire, Multidimensional
Fatigue Inventory, and Multiple Abilities Symptom Questionnaire. The blood will be tested by
the UAB Hospital Labs to ensure that the participant meets the study criteria. The ECG will
be forwarded to the study physician who will assess for evidence of conduction abnormalities
or of ischemia. If the blood tests or ECG are abnormal, the study physician will determine if
the participant should be advised to see their PCP. Following availability of all results
from the screening visit, participants will be contacted via phone and informed of their
eligibility to attend the experimental session.
During the experimental session, the administration of endotoxin, brain imaging, and related
procedures will be performed at the CRU. No fasting is required prior to this visit, and
participants will be asked to eat breakfast prior to arrival and will be provided with meal
suggestions. Baseline vital sign measurements consisting of resting blood pressure and pulse
rate will be measured and recorded within 60 minutes prior to the start of imaging. ECG and
pregnancy tests will be repeated and participants will be excluded from participation in the
session if conduction abnormalities are found (same criteria as used during screening) or if
participants are found to be pregnant. Participants will undergo MRI imaging for
approximately 1 hour. Participants will leave the scanner and complete questionnaire measures
assessing participant's current level of fatigue, pain, and mood symptoms. Grip strength will
also be assessed. A low dose of endotoxin (0.3ng/kg) will then be administered by the study
nurse via intravenous infusion. Vital signs will be periodically monitored for the rest of
the session. Participants will remain in the laboratory for three hours before being placed
into the MRI scanner to complete a second, identical, imaging session. The self-report
questionnaire measures and grip strength will be repeated every hour following endotoxin
administration in order to quantify changes in symptoms due to LPS. To avoid participant
discomfort and to optimize study integrity, a standardized meal of approximately 600-kcal
will be provided to each participant between the two MRI sessions, as well as a later snack
of approximately 200-kcal. The meal is standardized to caloric quantity and timing to offset
any effects of food intake on the immune response.