Brain Mechanisms of Juvenile Fibromyalgia (JFM)
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Neuroimaging, Sensory sensitivity, Fatigue
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional Magnetic Resonance Imaging
Arm Description
Outcomes
Primary Outcome Measures
Functional brain activation differences
Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls
Secondary Outcome Measures
Functional brain activation differences
Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment
Full Information
NCT ID
NCT03612258
First Posted
July 26, 2018
Last Updated
March 9, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03612258
Brief Title
Brain Mechanisms of Juvenile Fibromyalgia
Acronym
JFM
Official Title
Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain, Neuroimaging, Sensory sensitivity, Fatigue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional Magnetic Resonance Imaging
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional Magnetic Resonance Imaging
Intervention Description
Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.
Primary Outcome Measure Information:
Title
Functional brain activation differences
Description
Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Functional brain activation differences
Description
Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Payne, MA
Phone
513-803-0288
Email
Michael.Payne@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Lopez-Sola, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Payne, MA
Phone
513-803-2088
Email
Michael.Payne@cchmc.org
First Name & Middle Initial & Last Name & Degree
Marina Lopez-Sola, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will become available after main study results (data from primary outcomes/aims of the study) have been published
Learn more about this trial
Brain Mechanisms of Juvenile Fibromyalgia
We'll reach out to this number within 24 hrs