Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 7:53 PM
Study NCT ID:
NCT03612258
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Mechanisms of Juvenile Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional brain activation differences', 'timeFrame': 'Baseline', 'description': 'Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls'}], 'secondaryOutcomes': [{'measure': 'Functional brain activation differences', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Functional Magnetic Resonance Imaging: differences in response to painful, non-painful sensory, and emotion-eliciting stimuli before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Pain', 'Neuroimaging', 'Sensory sensitivity', 'Fatigue'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '37326678', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria)\n* Right handed\n* Functional Disability Index score ≥ 7, indicating at least mild disability\n* Stable medication regimen for 3 weeks prior to MRI scan\n\nExclusion Criteria:\n\n* Non-MRI compatible metal objects in the body (including braces, permanent upper retainers)\n* Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus)\n* Major psychiatric diagnoses (e.g. bipolar disorder, obsessive compulsive disorder, schizophrenia) or documented developmental delay\n* Taking opioid pain medication'}, 'identificationModule': {'nctId': 'NCT03612258', 'acronym': 'JFM', 'briefTitle': 'Brain Mechanisms of Juvenile Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia', 'orgStudyIdInfo': {'id': 'CIN_brainjfm_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional Magnetic Resonance Imaging', 'interventionNames': ['Diagnostic Test: Functional Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Functional Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.', 'armGroupLabels': ['Functional Magnetic Resonance Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Robert Coghill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will become available after main study results (data from primary outcomes/aims of the study) have been published', 'ipdSharing': 'YES', 'description': 'We plan to share behavioral MRI task data and functional brain imaging data, after the main results of the study have been published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Coghill', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}