FibromyalgiaJFMNCT03612258
Brain Mechanisms of Juvenile Fibromyalgia
A study testing Functional Magnetic Resonance Imaging in people with Fibromyalgia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Functional Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Functional Magnetic Resonance Imaging
- Keywords
- Fibromyalgia, Pain, Neuroimaging, Sensory sensitivity, Fatigue
- Medical subject headings
- Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingDiagnostic test
Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Functional Magnetic Resonance Imaging | Experimental | Not described Receives: Diagnostic Test: Functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain activation differences
Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls
Measured: Baseline
Secondary outcomes (1)
Functional brain activation differences
Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start28 Feb 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Coghill, Children's Hospital Medical Center, Cincinnati
- Investigators
- Robert Coghill, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612258
- Sponsor's protocol ID
- CIN_brainjfm_001
- Acronym
- JFM
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2018
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share behavioral MRI task data and functional brain imaging data, after the main results of the study have been published.
Publications
Tong H, Maloney TC, Payne MF, Sunol M, Dudley JA, King CD, Ting TV, Kashikar-Zuck S, Coghill RC, Lopez-Sola M. Augmented pain-evoked primary sensorimotor cortex activation in adolescent girls with juvenile fibromyalgia. Pain. 2023 Oct 1;164(10):2316-2326. doi: 10.1097/j.pain.0000000000002933. Epub 2023 Jun 16.
PubMed 37326678
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia
- ClinicalTrials.gov ID
- NCT03612258
- Acronym / sponsor ID
- JFM / CIN_brainjfm_001
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Pain, Neuroimaging, Sensory sensitivity, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Magnetic Resonance Imaging | Experimental | Diagnostic Test: Functional Magnetic Resonance Imaging |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance ImagingFunctional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli. | Diagnostic test | Functional Magnetic Resonance Imaging |
Primary outcome
Functional brain activation differences
Time frame: Baseline
Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls
1 secondary outcome
Functional brain activation differences
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 37326678Tong H, Maloney TC, Payne MF, Sunol M, Dudley JA, King CD, Ting TV, Kashikar-Zuck S, Coghill RC, Lopez-Sola M. Augmented pain-evoked primary sensorimotor cortex activation in adolescent girls with juvenile fibromyalgia. Pain. 2023 Oct 1;164(10):2316-2326. doi: 10.1097/j.pain.0000000000002933. Epub 2023 Jun 16.
- Individual participant dataSharing planned: Yes. We plan to share behavioral MRI task data and functional brain imaging data, after the main results of the study have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Coghill, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging in people with Fibromyalgia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional brain activation differences (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.