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Adolescents With Migraine: What's Stress Got To Do With It? (Adostress)

This study is currently recruiting participants.
Verified December 2016 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02259387
First Posted: October 8, 2014
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of the study: those with migraines (cases) and those without migraines or headaches (controls). Each arm will answer several of the same questionnaires and have hair cortisol samples taken multiple times over the course of 12 weeks.

Condition
Headache, Migraine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adolescents With Migraine: What's Stress Got To Do With It?

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Correlation between hair cortisol and perceived stress [ Time Frame: 12 weeks ]
    Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.

  • Correlation between headache frequency, perceived stress, and hair cortisol. [ Time Frame: 12 weeks ]
    Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.


Biospecimen Retention:   Samples With DNA
Hair samples for cortisol.

Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Children with migraines will be placed into this group.
Controls
Children without migraines or headaches will be placed into this group.

Detailed Description:

The overall objective of this proposal is to better define the relationship between perceived stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently report stress as their migraine trigger, stress measurement and treatment are usually beyond the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents who need structured stress management, as well as provide objective evidence for the medical community, migraineurs (i.e. individuals who experience migraines), and their families, who may be reluctant to accept stress as a migraine factor. The rationale for this research is that scientific validation of an association between stress and migraine will inform future prevention studies in the headache field and potentially identify a stress biomarker for migraine.

This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33 adolescents without migraine for 12 weeks with the following aims:

Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in adolescents with and without migraine.

Hypothesis: The association between hair cortisol and perceived stress (3 month averages) will be a positive in both adolescents with and without migraine.

Aim 2: Measure the relationship between migraine frequency with perceived stress and hair cortisol concentration in adolescents with migraine.

Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair cortisol will be positive in adolescents with migraines.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population to be sampled is adolescents (13-17 years old) with migraines, both male and female. Migraines are common in the pediatric population with a prevalence as high as 10% in children 5-14 years old,1 and 28% in adolescents 15-19 years old (Split W, 1999).
Criteria

Inclusion criteria:

For Cases:

  • Diagnosis of Migraine as defined by the ICHD-II
  • At least 1 migraine per month

For Controls:

  • No diagnosis of Migraine as defined by ICHD-II
  • No diagnosis of Primary Headache Disorders as defined by ICHD-II

Exclusion Criteria for Migrainers and Non-migrainers:

  • A secondary headache disorder as defined by ICHD-II
  • A continuous headache (i.e. 24 hours a day every day)
  • An underlying neurological condition such as epilepsy, chiari malformation, or neurocutaneous disorder
  • A chronic medical illness including those illnesses that require chronic steroid use such as asthma, cancer or rheumatologic disorders
  • Subject has bleached hair in past 3 months.
  • Pubertal Tanner stage 1 or 2 (Hair cortisol concentration may depend on developmental stage; 59 Tanner staging will be performed by Dr. Kedia).
  • Subject is pregnant or has a positive pregnancy test.
  • Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial
  • Any and all other diagnoses or conditions which in the opinion of the primary investigator would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259387


Contacts
Contact: Bryan Wallace, BS 720-777-3293 bryan.wallace@childrenscolorado.org
Contact: Sita Kedia, MD 720-777-3958 sita.kedia@childrenscolorado.org

Locations
United States, Colorado
Colorado Children's Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Bryan Wallace    720-777-3293    bryan.wallace@childrenscolorado.org   
Contact: Sita Kedia, MD    720-777-3958    sita.kedia@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sita Kedia, MD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02259387     History of Changes
Other Study ID Numbers: 13-3128
UL1TR001082 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2014
First Posted: October 8, 2014
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms