Mind Body Balance for Pediatric Migraine (NCT04715685) | Clinical Trial Compass
RecruitingNot Applicable
Mind Body Balance for Pediatric Migraine
United States260 participantsStarted 2021-03-09
Plain-language 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 reduction.
Who can participate
Age range10 Years ā 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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What they're measuring
1
Change in number of headache days
Timeframe: baseline to post treatment (8 weeks post randomization)
Trial details
NCT IDNCT04715685
SponsorChildren's Hospital Medical Center, Cincinnati