Status:
RECRUITING
Mind Body Balance for Pediatric Migraine
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Headache
Headache Disorders
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief Summary
This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day r...
Detailed Description
In the United States, over 6 million children and adolescents suffer from migraine headaches and it is 1 of the 5 most prevalent childhood disorders. Mind and body approaches can significantly help th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04715685
Start Date
March 9 2021
End Date
May 31 2026
Last Update
November 28 2025
Active Locations (2)
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1
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229