NCT05814497 Supraspinal Processing of Sensory Aspects of Pain
| NCT ID | NCT05814497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Migraine in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 255 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 255 participants in total. It began in 2023-05-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: * Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? * What are predictors of recovery from chronic pain? * What brain systems are associated with the spread of pain? For this study participants will undergo: * Functional Magnetic Resonance Imaging (fMRI) * Quantitative Sensory Testing * Psychological Assessments
Eligibility 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.
Contact & Investigator
Robert Coghill, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05814497 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Migraine in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05814497 currently recruiting?
Yes, NCT05814497 is actively recruiting participants. Contact the research team at Catherine.Jackson@cchmc.org for enrollment information.
Where is the NCT05814497 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05814497 clinical trial?
NCT05814497 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Robert Coghill, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 255 participants.
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