The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: American Fibromyalgia Syndrome Association

Criteria

Inclusion Criteria:

• Female;

• Age 18-55, inclusive;

• Adequate English for study participation;

• (fibromyalgia group only) Meet 2010 American College of Rheumatology criteria for the diagnosis of fibromyalgia

• Able to undergo IV cannulation and to provide the requisite blood samples;

• BMI 18-39.9 inclusive;

• Resting heart rate ≥55

• Supine systolic blood pressure of <140mmHg and >100mmHg AND

• Diastolic blood pressure <90mgHG and >60mmHg at screening.

Exclusion Criteria:

• Cardiovascular, immune or infectious disease (e.g. HIV, HCV), or diabetes;

• At screening, a 12-lead ECG demonstrating QTc>450 or QRS >120msec. If the QTc exceeds 450msec, or QRS exceeds 120msec, the ECG will be repeated x2 and the median of the three values will be used to determine the participant's eligibility.

• Rheumatologic or autoimmune disease;

• Vaccine administered within 4 weeks of study participation;

• Viral or bacterial illness requiring medical attention and/or antibiotics within 3 months of study participation, or any illness or fever within 1 month of study participation;

• Surgical procedure within 3 months of study participation;

• Regular use of anti-inflammatory of immunomodulatory drugs (occasional use of NSAIDs is not an exclusion as long as the participant does not administer within 5 days of study participation);

• Current use of opioid medication;

• Current smoker or ceased smoking ≤12 months prior to participation;

• High alcohol consumption;

• Consumption of drugs of abuse (except alcohol);

• Significant psychological comorbidity that in the discretion of the investigator compromises study integrity;

• Current participation in any other research;

• Ongoing litigation or worker's compensation claim;

• Hospital Anxiety and Depression score indicating clinically significant depression;

• Currently pregnant or positive screening urine pregnancy test;

• Complete blood count values outside the normal clinical ranges, erythrocyte sedimentation rate (ESR) >60, C-reactive protein (CRP) >3, positive rheumatoid factor (RHF), or positive antinuclear antibodies (ANA).