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NCT04715685Active, not recruiting

Mind Body Balance for Pediatric Migraine

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
260 (estimated)
First submitted
15 Jan 2021
Start date
9 Mar 2021
Primary completion date
1 Nov 2026
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Diseases
Migraine
NCT number
NCT04715685

What you commit to

  • Study type: Interventional
  • Planned participants: 260
  • From 9 Mar 2021 to the primary completion date, 1 Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Continuous migraine defined as unrelenting headache for a 28 day period
  • Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)

Who the study is looking for

  • 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

Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado/Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.