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OpenTrials
Completed

NCT Number: NCT00750594

Patent Foramen Ovale in Children With Migraine Headaches

This study will be the first to provide data about the relationship between PFO and migraine in children. By establishing the actual prevalence, we will better understand if PFO plays a role in the occurence of pediatric migraine and, thus, provide the incentive to perform additional studies evaluating whether PFO closure is an effective treatment option for pediatric migraine. For children with migraine headaches, discovering novel and effective treatments would be life altering.

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Key information

Conditions

Migraine Headaches Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary Children's Medical Center

Salt Lake City, Utah, 84112, United States

About this study

Specific Aim 1 Using contrast transthoracic echocardiography, compare the prevalence of a PFO in children with migraine headache with the established incidence of PFO published for the general population.

Specific Aim 2 Using contrast transcranial Doppler, examine the relationship between the degree of right to left atrial shunting with the presence or absence of aura in children with migraine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than or equal to six years of age and less than 18 years of age.
  • Diagnosis of migraine headache based on the International Headache Society Criteria.
  • English speaking patients (and parent/guardians where appropriate).
  • Signed informed consent/assent (as appropriate) given by patient, parent or legal guardian.

Exclusion criteria

  • Inability to cooperate with imaging studies.
  • Known congenital heart disease.
  • Parent or guardian is unwilling to have their child undergo contrast echocardiography.

Treatment and study plan

Primary outcomes

  1. The prevalence of PFO in children with migraine headaches

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Primary Children's Hospital

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2008
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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