Clinical Trials / Research Studies

Clinical Trials / Research Studies

Migraine Study for Children and Teens 10 to 17 Years Old

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to test whether changes in brain activity are related to differences in the way children and teens feel pain both before and after receiving one of five different treatments (3 behavioral therapies, a placebo pill, or a study medication).

Who can participate?

Children and teens 10 to 17 years old who have migraines and are willing to keep a daily headache diary, complete 2 MRIs, undergo sensory testing, and complete questionnaires may be eligible to participate.

Conditions

  • Headaches - Migraines
  • Neurology

What will happen in the study?

This study includes 5 to 8 study visits to Cincinnati Children’s over 6 months. There are 3 phases in the study. Here are some of the things that will happen in this study.

During the first screening phase of 4 weeks, your child will:

  • Be asked to keep a daily headache diary
  • Complete questionnaires
  • Have an ECG (an electrocardiogram — abbreviated as EKG or ECG — is a test that uses a machine to measure the electrical activity of the heartbeat) and an MRI
  • Undergo sensory testing using pressure and temperature stimuli

In the second phase or intervention phase of 12 weeks, your child will:

  • Receive 1 of the 5 interventions by chance (like flipping a coin) which include Behavioral Treatment A, B or C, a placebo pill, or the study medication amitriptyline for 8 weeks followed by a safety phone call 4 weeks later
  • Be asked to keep a daily headache diary
  • After about 8 weeks of receiving his/her intervention, be asked to come back in to repeat the questionnaires, MRI, and sensory testing

In the third phase or follow-up phase, you will be contacted about 3 months after the final study visit, and you and your child will be asked to complete an online set of questionnaires about your child’s headaches, medicine use, healthy habits, illnesses, quality of life, pain and sleep.

You and your child will be given a consent form that thoroughly explains all of the details of the study including the specifics of the behavioral interventions. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your child may not have a direct medical benefit from being in this study. However, when we complete this study, we hope that we will know how behavioral therapies (A, B or C), placebo or the study medication amitriptyline might help other children with migraines.

What are the bad things that can happen from this research?

We will discuss possible risks and discomforts from being in this study with you and your child.

Will you/your child be paid to be in this research study?

Families will receive up to $770 for time and effort to complete the study.

Contact

Contact Us.Leigh Ann Chamberlin
513-636-9739
CAPstudy@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Scott Powers, PhD
Robert Coghill, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center