Mind and body intervention for pediatric migraine relief
Mind Body Balance for Pediatric Migraine
This study is testing a new mind and body treatment to see if it can help children and teens aged 10 to 17 with migraines have fewer headache days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04715685 on ClinicalTrials.gov |
What this trial studies
This study evaluates a nurse-delivered mind and body intervention designed to reduce headache days in children and adolescents aged 10 to 17 suffering from migraines. Using a factorial design, it tests different doses of three treatment components: session duration, home practice support intensity, and adherence prompts. The goal is to optimize the intervention package for effective migraine management. Participants will be monitored over 12 weeks to assess the impact of the intervention on their migraine frequency and severity.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 10 to 17 diagnosed with migraines that meet specific criteria.
Not a fit: Patients with migraine frequencies outside the specified range or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the frequency of migraine headaches in pediatric patients.
How similar studies have performed: Other studies have shown promise in using mind and body approaches for migraine treatment, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria * Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28. * PedMIDAS: PedMIDAS Disability Score \> 4, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy * Use of one or more of the following prescribed nutraceuticals and/or preventive anti-migraine medications at the time or randomization or be on a stable dose of one or more of the following throughout the 12 weeks of the study \[Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)\] * Language: English speaking, able to complete interviews and questionnaires in English Exclusion Criteria: * Continuous migraine defined as unrelenting headache for a 28 day period * Must agree not to take non-specific acute medication, such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month (to prevent medication overuse headache) * PedMIDAS Disability Score \> 140, indicating extreme disability that may require more comprehensive, multi-component therapy * Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods) * Present severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) or other circumstances, that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado/Children's Hospital Colorado — Aurora, Colorado, United States (Active_not_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Scott Powers, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: LeighAnn Chamberlin, MEd
- Email: leighann.chamberlin@cchmc.org
- Phone: 513-636-9739
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.