Brain Mechanisms of Juvenile Fibromyalgia

NCT03612258 | Completed

• 1 other identifier: CIN_brainjfm_001
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain; Neuroimaging; Sensory sensitivity; Fatigue

Outcome Measures

Primary Outcomes (1)

• Functional brain activation differences

  Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls

  Baseline

Secondary Outcomes (1)

• Functional brain activation differences

  Baseline and 8 weeks

Study Arms (1)

Functional Magnetic Resonance Imaging

EXPERIMENTAL

Diagnostic Test: Functional Magnetic Resonance Imaging

Interventions

Functional Magnetic Resonance Imaging DIAGNOSTIC_TEST

Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.

Functional Magnetic Resonance Imaging

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 37326678 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Coghill, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: February 28, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after main study results (data from primary outcomes/aims of the study) have been published

Locations

US (1)