Mind Body Balance for Pediatric Migraine

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Mind Body Balance for Pediatric Migraine," is exploring a new approach to help children and teenagers with migraine headaches. The study is testing a special program led by nurses that combines different mind-body techniques to see how well they can reduce the number of headache days. Researchers want to find out which combination of these techniques works best for young people experiencing migraines, whether they have migraines with or without aura (warning signs before a headache) or chronic migraines.

To participate, children aged between 1 to 17 years must have a diagnosed migraine (according to specific guidelines) that occurs at least 4 to 28 times a month and causes some disruption in their daily activities. They should also be able to speak English and complete interviews and questionnaires. Participants will receive guidance and support throughout the 12-week study. It’s important to note that those who have severe or continuous migraines, or certain health conditions, may not be eligible. This trial aims to provide new insights and potential relief for young people struggling with migraines.

Gender

ALL

Eligibility 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