Understanding how the brain processes chronic pain in children
Supraspinal Processing of Sensory Aspects of Pain
This study is trying to understand how children's brains handle chronic pain from conditions like migraines and fibromyalgia to see what helps them recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05814497 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the brain mechanisms involved in chronic pain among pediatric patients suffering from various conditions such as migraines, complex regional pain syndromes, and fibromyalgia. By utilizing functional Magnetic Resonance Imaging (fMRI), quantitative sensory testing, and psychological assessments, the research will identify shared and distinct brain systems engaged by different forms of chronic pain. The study will also explore predictors of recovery and the brain systems associated with the spread of pain. A total of 400 patients aged 10 to 17 will be recruited to participate in this comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates are children aged 10 to 17 with a diagnosis of chronic pain conditions such as migraines or complex regional pain syndromes.
Not a fit: Patients with comorbid neurological diseases or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for chronic pain in children.
How similar studies have performed: While there is ongoing research in chronic pain mechanisms, this study's specific focus on pediatric populations and the integration of neuroimaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), diffuse MSK (widespread MSK pain), or CRPS * If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit. * Male or female, age 10 -17 (inclusive) * English speaking, able to complete interviews and questionnaires in English Exclusion Criteria: * Weight/size incompatible with MRI scanner * Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment * Claustrophobia * Youth who are pregnant * Any comorbid rheumatic disease, diagnosis of epilepsy, other neurological diseases, or medical condition (e.g. diabetes, cancer, IBD) * Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study * Skin conditions or past skin damage on the arms or legs in or near sites of sensory testing * Outside the age range (9 years old or younger; 18 years or older) at the time of consent * History of \> 1 month opioid treatment.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Robert Coghill, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Catherine Jackson, MSc
- Email: Catherine.Jackson@cchmc.org
- Phone: 5136360669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.