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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:13 - 17
Updated:6/10/2018
Start Date:September 12, 2014
End Date:October 15, 2017

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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.

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.

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.
We found this trial at
1
site
Aurora, Colorado 80045
Phone: 720-777-3293
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from
Aurora, CO
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