153 Participants Needed

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 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.

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 safety data exists for fMRI in juvenile fibromyalgia treatment?

The provided research does not directly address the safety data of fMRI in juvenile fibromyalgia treatment. The studies focus on using fMRI to understand brain activity and pain processing in fibromyalgia patients, but they do not discuss safety outcomes or adverse effects related to the use of fMRI itself.12345

Is the treatment in the trial 'Brain Imaging for Juvenile Fibromyalgia' promising?

The treatment in the trial 'Brain Imaging for Juvenile Fibromyalgia' is promising because it uses brain imaging to better understand how pain is processed in the brain of those with juvenile fibromyalgia. This could lead to more effective ways to manage and treat pain in young people with this condition.12346

What data supports the idea that Brain Imaging for Juvenile Fibromyalgia is an effective treatment?

The available research shows that brain imaging, specifically functional MRI, helps us understand how pain is processed in the brain of those with juvenile fibromyalgia. Studies have found that adolescents with this condition experience greater pain intensity and unpleasantness compared to healthy individuals. This suggests that brain imaging can identify changes in brain activity related to pain, which might help in developing better treatments. However, the research does not directly show that brain imaging itself is an effective treatment, but rather a tool to understand the condition better.12346

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

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]
In a study involving 16 patients with fibromyalgia (FM) and 16 matched controls, fMRI revealed that patients exhibited greater activation in 13 brain regions when subjected to similar pressure levels that caused pain, indicating heightened pain processing in FM.
When both groups experienced similar subjective pain levels, their brain activation patterns were more alike, suggesting that FM patients have an augmented response to pressure, which may contribute to their chronic pain symptoms.
Functional magnetic resonance imaging evidence of augmented pain processing in fibromyalgia.Gracely, RH., Petzke, F., Wolf, JM., et al.[2022]
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

Reduced Cortico-Cortical Resting-State Connectivity in Sensory Systems is related to Bodily Pain in Juvenile Fibromyalgia. [2023]
Functional magnetic resonance imaging evidence of augmented pain processing in fibromyalgia. [2022]
Augmented pain-evoked primary sensorimotor cortex activation in adolescent girls with juvenile fibromyalgia. [2023]
Functional imaging of pain in patients with primary fibromyalgia. [2022]
Biology and therapy of fibromyalgia. Functional magnetic resonance imaging findings in fibromyalgia. [2022]
Evaluation of the effectiveness of pregabalin in alleviating pain associated with fibromyalgia: using functional magnetic resonance imaging study. [2021]
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