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

Completed

Conditions studied: Headache, Migraine

In brief

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.

Key facts

Study ID

NCT02259387

Run by

University of Colorado, Denver

People needed

100

Starts

2014-09-12

Expected to finish

2017-10-15

Last updated by the study team

2018-06-08

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• Colorado Children's Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.