Brain Imaging for Juvenile Fibromyalgia

(JFM Trial)

MP
CJ
Overseen ByCatherine Jackson
Age: < 18
Sex: Female
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how teenage girls with juvenile fibromyalgia experience pain and emotions differently in their brains compared to girls without the condition. Researchers will use brain scans (fMRI, or Functional Magnetic Resonance Imaging) to observe these differences and determine if they change with various treatments over time. Girls diagnosed with juvenile fibromyalgia, who are right-handed and experience mild or greater disability, can participate. As an unphased study, this trial offers a unique opportunity to contribute to understanding juvenile fibromyalgia and potentially improve future treatments.

Do I have to stop taking my current medications for the trial?

The trial requires that you have a stable medication regimen for 3 weeks before the MRI scan, so you should not change your current medications during that time. However, you cannot participate if you are taking opioid pain medication.

What prior data suggests that functional magnetic resonance imaging is safe for adolescents?

Research has shown that functional magnetic resonance imaging (fMRI) is often used to study fibromyalgia and involves no invasive procedures, making it generally easy for patients to handle. fMRI, a type of brain scan, helps doctors observe brain activity by tracking blood flow.

While specific safety information for fMRI in young people with fibromyalgia is lacking, many studies have used fMRI with both adults and children without major safety concerns. It does not use radiation, making it safer than some other imaging methods. The most common issues might include discomfort in the machine or claustrophobia, but these are not harmful.

Overall, fMRI is considered safe for most people, including teenagers. There are no known harmful side effects from the magnetic fields or radio waves used in fMRI.12345

Why are researchers excited about this trial?

Researchers are excited about using Functional Magnetic Resonance Imaging (fMRI) for juvenile fibromyalgia because it offers a new way to explore how the brain is involved in this condition. Unlike typical treatments that focus on managing symptoms through medication or physical therapy, fMRI provides a detailed look at brain activity and could uncover underlying neurological patterns. This technique could potentially lead to more targeted treatment strategies, offering hope for more effective management of fibromyalgia in young patients.

What evidence suggests that this imaging technique is effective for studying juvenile fibromyalgia?

Research shows that functional magnetic resonance imaging (fMRI), which participants in this trial will undergo, can reveal differences in how the brains of people with fibromyalgia handle pain. Studies have found that when people with fibromyalgia experience certain sensations, their brain responses differ from those without the condition, suggesting a unique way of processing pain. Additionally, evidence indicates that children with chronic pain conditions like fibromyalgia have less connection between brain areas that sense pain. These findings suggest that fMRI could help researchers understand and improve treatments for juvenile fibromyalgia by focusing on these specific brain changes.15678

Who Is on the Research Team?

RC

Robert Coghill, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Juvenile Fibromyalgia by a specialist.
You are right handed.
I have at least mild disability.
See 1 more

Exclusion Criteria

I have a condition like juvenile arthritis or lupus.
You have metal objects in your body that are not safe for an MRI. This includes things like braces or permanent retainers.
You have been diagnosed with serious mental health conditions like bipolar disorder, obsessive compulsive disorder, or schizophrenia. Or you have a documented delay in your development.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Functional Magnetic Resonance Imaging (fMRI) scans to assess baseline brain activation differences in pain and emotional processing

1 week

Treatment

Participants undergo different treatment strategies such as neuromuscular training, cognitive behavioral therapy, and graded aerobic exercise

8-12 weeks

Post-treatment Assessment

fMRI scans to evaluate changes in neural processing of pain and emotion after treatment

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Magnetic Resonance Imaging
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Functional Magnetic Resonance ImagingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Published Research Related to This Trial

Neuroimaging techniques like fMRI have advanced our understanding of how the brain processes pain, particularly in conditions like fibromyalgia.
This review highlights the importance of supraspinal mechanisms in pain perception and integrates existing studies to explain how fMRI can reveal central pain processing mechanisms in fibromyalgia.
Biology and therapy of fibromyalgia. Functional magnetic resonance imaging findings in fibromyalgia.Williams, DA., Gracely, RH.[2022]
In a study of 37 female adolescents with juvenile-onset fibromyalgia (JFM) compared to 43 healthy peers, significant reductions in resting-state functional connectivity (rsFC) were found in key brain areas related to sensory processing, particularly in the paracentral lobule and primary somatosensory cortex, which are associated with bodily pain.
The findings suggest that reduced sensory integration in these brain regions may contribute to the chronic pain experienced in JFM, while increased connectivity with regions involved in emotional processing indicates a potential shift in how pain is perceived, emphasizing the need for targeted interventions.
Reduced Cortico-Cortical Resting-State Connectivity in Sensory Systems is related to Bodily Pain in Juvenile Fibromyalgia.Suñol, M., Dudley, J., Payne, MF., et al.[2023]
Adolescent girls with juvenile fibromyalgia (JFM) experience heightened sensitivity to pain, reporting greater pain intensity and unpleasantness compared to healthy peers when subjected to noxious pressure.
Functional MRI scans revealed increased activation in the primary somatosensory cortex in the JFM group, indicating that this heightened brain response may be linked to their widespread pain and could suggest a mechanism of central sensitization.
Augmented pain-evoked primary sensorimotor cortex activation in adolescent girls with juvenile fibromyalgia.Tong, H., Maloney, TC., Payne, MF., et al.[2023]

Citations

Neurophysiology of Resilience in Juvenile Fibromyalgia - PMCResilience may be a protective factor in coping with pain, reducing affective burden, and promoting positive outlooks.
Altered Functional Magnetic Resonance Imaging Responses ...The aim of this study was to characterize brain responses to non-nociceptive sensory stimulation in FM patients and their relationship to subjective sensory ...
Brain Imaging for Juvenile Fibromyalgia (JFM Trial)Functional MRI showed that pregabalin led to a significant decrease in brain activation in 13 regions associated with pain processing, indicating its efficacy ...
Reduced Resting-State Connectivity in Sensory Regions ...A study found reduced resting-state functional connectivity (rs-FC) in the primary somatosensory system of children with chronic pain.
Brain structural differences between fibromyalgia patients ...In this study, we investigated the structural differences between FM patients and healthy control (HC) subjects using a multivariate approach.
Brain Structural Changes During Juvenile FibromyalgiaThis study was undertaken to characterize gray matter volume (GMV) alterations in juvenile FM patients for the first time, and to investigate their functional ...
Fibromyalgia - StatPearls - NCBI Bookshelf - NIHChanges in brain morphology and function: Magnetic resonance imaging (MRI) studies in patients with fibromyalgia have revealed several changes ...
Investigating Descending Pain Regulation in Fibromyalgia ...This study aimed to apply novel analysis methods to investigate altered neural processes underlying pain sensitivity in FM in functional magnetic resonance ...
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