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Brain Mechanisms of Juvenile Fibromyalgia (JFM)

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ClinicalTrials.gov Identifier: NCT03612258
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Marina Lopez Sola, Children's Hospital Medical Center, Cincinnati

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Diagnostic Test: Functional Magnetic Resonance Imaging Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional Magnetic Resonance Imaging 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.




Primary Outcome Measures :
  1. Functional brain activation differences [ Time Frame: Baseline ]
    Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls


Secondary Outcome Measures :
  1. Functional brain activation differences [ Time Frame: Baseline and 8 weeks ]
    Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612258


Contacts
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Contact: Michael Payne, MA 513-803-0288 Michael.Payne@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michael Payne, MA    513-803-2088    Michael.Payne@cchmc.org   
Principal Investigator: Marina Lopez-Sola, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Marina Lopez-Sola, PhD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Marina Lopez Sola, Assistant Professor, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03612258     History of Changes
Other Study ID Numbers: CIN_brainjfm_001
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share behavioral MRI task data and functional brain imaging data, after the main results of the study have been published.
Supporting Materials: Study Protocol
Time Frame: Data will become available after main study results (data from primary outcomes/aims of the study) have been published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marina Lopez Sola, Children's Hospital Medical Center, Cincinnati:
Fibromyalgia
Pain
Neuroimaging
Sensory sensitivity
Fatigue

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases