| NCT ID | NCT05752396 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2023-03-01 with a primary completion date of 2028-07-01.
⚠ 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 observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: * quantitative sensory testing * blood draw * sleep assessment * questionnaires
Eligibility Criteria
Inclusion Criteria: 1. General Criteria * Access to the internet either by laptop, tablet, or phone (for REDCap Surveys) * English-speaking * Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent 2. Control Specific Criteria * No history/active chronic pain 3. Patient Specific 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), or diffuse MSK (widespread MSK pain) * 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. Exclusion Criteria: 1. General Criteria * Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing * Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes) 2. Control Specific Criteria * Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric) 3. Patient Specific Criteria * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05752396 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 19 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05752396 currently recruiting?
Yes, NCT05752396 is actively recruiting participants. Contact the research team at Kacie.Peters@cchmc.org for enrollment information.
Where is the NCT05752396 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05752396 clinical trial?
NCT05752396 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 420 participants.
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