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Brain Imaging for Juvenile Fibromyalgia (JFM Trial)

N/A
Recruiting
Led By Marina Lopez-Sola, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria)
Functional Disability Index score ≥ 7, indicating at least mild disability
Must not have
Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well different treatments work for fibromyalgia in girls by studying brain activity.

Who is the study for?
This trial is for adolescent females with juvenile-onset fibromyalgia who are right-handed, have a mild disability or greater, and have been on stable medication for at least 3 weeks. They must be diagnosed by a specialist using specific criteria. Those with major psychiatric conditions, opioid use, other rheumatic diseases, or non-MRI compatible metal in their body cannot participate.
What is being tested?
The study uses functional Magnetic Resonance Imaging (fMRI) to compare how adolescent girls with juvenile fibromyalgia and healthy individuals process pain and emotions in the brain. It also looks at changes over time before and after treatment strategies.
What are the potential side effects?
Since this trial involves fMRI scanning rather than medication or invasive procedures, side effects are minimal but may include discomfort from lying still during the scan or anxiety within the confined space of the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Juvenile Fibromyalgia by a specialist.
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I have at least mild disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition like juvenile arthritis or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Brain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Functional Magnetic Resonance ImagingExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Functional Magnetic Resonance Imaging
2017
Completed Phase 4
~920

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,257 Total Patients Enrolled
5 Trials studying Fibromyalgia
1,103 Patients Enrolled for Fibromyalgia
Marina Lopez-Sola, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Robert Coghill, PhDPrincipal Investigator - Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
715 Total Patients Enrolled
1 Trials studying Fibromyalgia
500 Patients Enrolled for Fibromyalgia
~10 spots leftby Nov 2025
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