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Migraine HeadacheNCT02742272

Clinical Decision Rule for Pediatric Intracranial Pathology

An observational study of Migraine Headache and Headache, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to develop a clinical decision rule for patients seen in the pediatric emergency department for possible intracranial pathology. This a prospective study evaluating patients presenting with headache and migraine. The study is observational and does not impact patient care. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Migraine Headache, Headache
How many people
500 participants
Where
1 siteUnited States
Study dates
Sep 2015to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients presenting to the ED with Headache or Migraine who meet the inclusion criteria and do not meet any exclusion criteria.

Who may be able to join

  • Age 6-18 years
  • Chief complaint of headache or migraine

Who cannot join

  • Head trauma within 48 hours
  • Previous neurosurgery (shunt included)
  • Personal history of brain tumor
  • History of stroke or vascular abnormality
  • Sickle Cell Disease
  • Fever (temperature over 38 degrees C)

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Children's Hopsitals and Clinics of Minnesota

    Saint Paul, Minnesota, 55102

    Meghan Cain, MD, 612-813-6843, Meghan.cain@childrensmn.org

    Kristin Frenn, MPH, 612.813.7104, kristin.frenn@childrensmn.org

    Recruiting

Other trials in United States

About this study

Official title: Development of a Clinical Decision Rule to Identify Pediatric Patients With Headache at Low Risk for Intra-cranial Pathology

The purpose of this study is to develop a clinical decision rule for patients seen in the pediatric emergency department for possible intracranial pathology. This a prospective study evaluating patients presenting with headache and migraine. The study is observational and does not impact patient care.

Read the detailed description

Background/Question: A significant number of children who present to the Emergency Department (ED) with headache or migraine undergo head imaging with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). However, there is relatively low yield in imaging neurologically normal patients based on prior studies. The goal of this study is to describe the utilization of head CT or MRI among pediatric ED patients with headache and migraine. The investigators plan to evaluate clinical and examination characteristics of these patients, and use this information to develop a clinical decision rule to help providers predict the risk of finding an abnormality that affects patient treatment.

Design: The investigators will perform a study of all children between 6 and 18 years of age who present to the ED with headache or migraine. At the time of the visit providers will be asked to complete a questionnaire regarding exam and history without making any changes to patient care. The investigators will also contact a sub-group of patients who do not undergo MRI or CT, 12-14 weeks after discharge to ask about subsequent headache care after leaving our facility.

Methods: All children age 6-18 years who present to the ED with a chief complaint of headache or migraine will be eligible for the study. Patients will be excluded if they meet any of the following criteria: trauma within 48 hours, previous neurosurgery (shunt included), known tumor, history of cerebral hemorrhage/ischemia, Sickle Cell Disease, thrombophilia, bleeding disorder or non-English speaker. ED Research Assistants and ED staff physicians and nurse practitioners will screen potential candidates and ask providers to review the inclusion criteria. If the eligibility criteria are met, the provider will complete a standardized data collection form regarding exam and history findings. Patient care will not be impacted or altered. Research Assistants will also provide a Parent Information Sheet (either during the visit, or by mail following the ED visit) to the family of those patients who are enrolled informing them they may be contacted following discharge. Medical records will be reviewed for all eligible patients to obtain information on patient demographics, course of treatment and diagnosis. For those patients who do not have any head CT or MRI performed at their visit, the family will be contacted 12-14 weeks later to determine if they have had subsequent care for their headache. If the family is unable to be reached by phone, the patient chart will be reviewed for any other pertinent visits.

Analysis: For each patient characteristic examined, the investigators will look for a statistically significant difference between those patients who have normal head imaging, and those with abnormal imaging. Using the characteristics that are significantly different, the investigators will develop a clinical decision rule to help providers assess the risk of significant findings in an individual patient. The investigators will also develop a decision tree to help aid providers when deciding which patients need head imaging. A sample of patients will have two independent assessments to allow us to look for evidence of inter-rater reliability in our questionnaires.

Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02742272
Study groupRoleWhat they receive
ED Headache or Migraine PatientsThe investigators will perform a prospective cohort study of patients ages 6-18 years presenting to the ED with a complaint of headache or migraine over a 12 month period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial pathology identified by imaging studies

    Measured: within 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02742272
Sponsor's protocol ID
1506-076
Status last verified
Apr 2016
First submitted
20 Nov 2015
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Larson DB, Johnson LW, Schnell BM, Goske MJ, Salisbury SR, Forman HP. Rising use of CT in child visits to the emergency department in the United States, 1995-2008. Radiology. 2011 Jun;259(3):793-801. doi: 10.1148/radiol.11101939. Epub 2011 Apr 5.

    PubMed 21467249

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine Headache and Headache, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meghan Cain, MD (6128136843, meghan.cain@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial pathology identified by imaging studies (time frame: within 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742272, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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