Status:
COMPLETED
Adolescents With Migraine: What's Stress Got To Do With It?
Lead Sponsor:
University of Colorado, Denver
Conditions:
Headache, Migraine
Eligibility:
All Genders
13-17 years
Brief Summary
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: tho...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 12 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02259387
Start Date
September 12 2014
End Date
October 15 2017
Last Update
June 8 2018
Active Locations (1)
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1
Colorado Children's Hospital
Aurora, Colorado, United States, 80045