Brain Mechanisms of Juvenile Fibromyalgia

Study Purpose

This study evaluates whether differences exist between adolescent females with juvenile-onset fibromyalgia and healthy controls in processing of pain and emotion at the neural level as assessed by functional magnetic resonance imaging (fMRI). The study includes a longitudinal component to evaluate changes in neural processing of pain and emotion before and after different treatment strategies.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	13 Years - 17 Years
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria) - Right handed.

- Functional Disability Index score ≥ 7, indicating at least mild disability.

- Stable medication regimen for 3 weeks prior to MRI scan.

Exclusion Criteria:

- Non-MRI compatible metal objects in the body (including braces, permanent upper retainers) - Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus) - Major psychiatric diagnoses (e.g. bipolar disorder, obsessive compulsive disorder, schizophrenia) or documented developmental delay.

- Taking opioid pain medication

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03612258
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Hospital Medical Center, Cincinnati
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Coghill, PhD
Principal Investigator Affiliation	Children's Hospital Medical Center, Cincinnati
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibromyalgia

Additional Details

Juvenile-onset fibromyalgia (JFM) is a chronic, widespread pain condition that primarily affects females. Previous work has shown increased sensitivity to painful and non-painful sensory stimuli in adults with fibromyalgia, as well as brain processing abnormalities associated with these stimuli. These abnormalities in adults are highly predictive of fibromyalgia status (as opposed to healthy status) in adults. Although JFM has some similar symptoms and features to fibromyalgia in adults, the neural mechanisms of JFM may be partially different, given the moment of sharp brain development characterising JFM. fMRI scans will be completed before and after different treatments for JFM (e.g. neuromuscular training + cognitive behavioral therapy, graded aerobic exercise) to investigate the effects of treatment on brain measures related to pain, fatigue and emotion processing.

Arms & Interventions

Arms

Experimental: Functional Magnetic Resonance Imaging

Interventions

Diagnostic Test: - Functional Magnetic Resonance Imaging

Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Catherine Jackson

[email protected]

513-636-0669

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